19 Biopharmaceutical jobs in the United States

**Biopharmaceutical Maintenance Technician**
Manufacturing
Agoura Hills, CA, US
Pay Rate Low: 22 | Pay Rate High: 25
+ Added - 10/06/2025
Apply for Job
**Biopharmaceutical Machine Operator**
We are seeking an experienced Machine Operator to join our operations team in a critical role supporting manufacturing, laboratory, and facility infrastructure.
**Position Overview**
**Location** : Agoura Hills, CA
**Pay** : $22-$25/hour
**Employment Type** : Contract
**Operational Schedule:** Night shift operations from 6:30 PM to 7:30 AM
**Work Days:** Thursday through Saturday, plus rotating Wednesday coverage
**Training Period:** Initial onboarding will occur during standard business hours (approximately 8:00 AM - 5:00 PM, Monday-Friday) for 2-6 weeks
**Key Responsibilities**
+ Execute complex installation, diagnostic, maintenance, and repair procedures on manufacturing and utility equipment.
+ Conduct comprehensive testing and maintain detailed operational logs across production facilities, utility systems, and analytical laboratories.
+ Create and maintain critical quality system documentation including:
+ Standard Operating Procedures and Change Control documentation.
+ Work Orders, Job Plans, and Non-Conformance reports.
+ Safety assessments including Hazard Risk and Job Hazard Analyses.
+ Ensure all activities comply with Good Manufacturing Practices, regulatory requirements, and company protocols.
**Specialized Requirements**
+ Apply knowledge of packaging systems and configurations.
+ Execute and document batch record procedures for inspection and packaging operations.
+ Perform component reconciliation and environmental exposure calculations.
**Required Qualifications**
+ Associate degree with 4+ years of relevant maintenance experience, OR High school diploma/GED with 6+ years of hands-on maintenance experience.
**Technical Skills**
+ Experience in pharmaceutical or biotechnology manufacturing environments, particularly with filling and finishing operations.
+ Understanding of Good Manufacturing Practice principles.
+ Ability to work independently while maintaining attention to detail and safety protocols.
_This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_
INDBH
#LI-DNP
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job Description

Job Description

Salary:

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the clients facilities.

This role is forCQV MANAGERrole to work on the validation of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor intermediate/junior specialists.

We are looking for candidates for our clients inRaleigh-Durham-Chapel Hill Area and Boulder, Colorado.

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites following all site safety requirements.
• Supervise contractors during critical testing of systems and equipment.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is an asset.
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of URSs, DQs, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Compensation : 80,000$-100,000$ per year based on industry experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma - Your Body. Your Hope. Your Cure.

POSITION SUMMARY

We are hiring for an experienced Biopharmaceutical Data Scientist who thrives on turning data into actionable insights. The ideal candidate has proven statistical expertise across Analytical Development and Quality, driving critical CMC decision-making. They're passionate about using data to accelerate life-saving treatments and expanding their reach to patients who need them most. They excel at building reproducible data products and drive impact autonomously in a fast-paced environment.

This role is based out of our Louisville, CO location, although, exceptional candidates based in Seattle, WA may be considered.

CORE ACCOUNTABILITIES

Specific responsibilities include:

• Drive statistical strategies for process validation and comparability, including risk-based PPQ approaches and direct interface with FDA/EMA statisticians during regulatory reviews
• Lead statistically robust study design and analysis to optimize manufacturing processes, establish control strategies, and support regulatory submissions per ICH/FDA/EMA guidance
• Build and maintain reproducible data science communication products including interactive dashboards, analytic reports, and other deliverables that effectively communicate complex findings to diverse stakeholders
• Collaborate using Git workflows for version control and code management
• Bridge scientific questions and computational solutions by translating problems into statistical models and applying optimal methods for each application
• Collaborate closely with scientists on research themes that span a diverse set of topics from immunology and molecular biology to process development and manufacturing
• Adherence to GMP when demanded by the specifics of projects, including timely completion of relevant training as provided by Umoja.

The successful candidate will have:

• Graduate degree (PhD or MS) in Statistics, Biostatistics, Computer Science, Bioinformatics, or related computational field with 2+ years (PhD) or 5+ years (MS) of experience.
• Strong foundation in applied statistics, statistical modeling, and method selection
• Demonstrated experience in computational problem-solving within a scientific research setting.
• Track record of developing analysis pipelines and reports
• Experience in scientific collaborations within therapeutics development with an ability to translate between scientific and computational domains.
• Experience with manufacturing statistics (process variability, specification setting, quality metrics)
• Advanced proficiency in R or Python
• Practical experience with Git workflows

Preferred Qualifications:

• Familiarity with data engineering and basic cloud tools (AWS)
• Experience with:
  • Building and deploying interactive dashboards, reports, and other analysis dissemination tools using appropriate technologies (R Markdown, Jupyter notebooks, Shiny, Dash, streamlit etc.)

• Omics assays (transcriptomics, proteomics, single-cell analysis, flow cytometry)
• AI/ML application development
• Familiarity with immunology and immune cell biology
• Working understanding of molecular mechanisms in cancer and cell therapy
• Experience working in biopharmaceutical R&D
• Ability to self-motivate to identify high-impact initiatives and drive them to completion
• Thrives in multidisciplinary teams while independently determining what needs to be done
• Proactively identifies opportunities to improve and expedite projects and workflows

Physical Requirements:

• Ability to sit for prolonged periods of time
• Ability to work onsite at least 2x per week in our Louisville, CO (ideal), or Seattle, WA location.

Salary Range: $142,630 - $176,190

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

Join a leading biopharmaceutical company in Huntsville, Alabama as a Lead Biopharmaceutical Process Engineer. This role is critical in the development, optimization, and scale-up of innovative biomanufacturing processes for novel therapeutic proteins and vaccines. You will be instrumental in ensuring the efficiency, robustness, and regulatory compliance of our upstream and downstream manufacturing operations. The successful candidate will possess a Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, or a related discipline, with a minimum of 7 years of experience in the biopharmaceutical industry. Responsibilities include designing and executing process development studies, performing risk assessments, and leading technology transfer activities from pilot scale to commercial manufacturing. You will troubleshoot complex process issues, implement process analytical technology (PAT), and stay abreast of emerging trends in bioprocessing, such as continuous manufacturing and single-use systems. This position demands strong analytical and problem-solving skills, a thorough understanding of GMP guidelines, and experience with cell culture, chromatography, filtration, and sterile fill-finish operations. Proficiency in process simulation software (e.g., Aspen Plus, SuperPro Designer) and statistical analysis tools (e.g., JMP, Minitab) is required. As a lead engineer, you will mentor junior team members, manage project timelines, and collaborate effectively with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs. We are looking for an individual with exceptional leadership qualities, excellent communication skills, and a passion for bringing life-saving medicines to patients worldwide. This is a unique opportunity to shape the future of biopharmaceutical manufacturing and contribute to impactful scientific advancements.

Territory: Orlando, FL  - Neurology

Target area for territory is Orlando, FL - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Deltona, Orlando, Clermont, Winter Haven, Merritt Island and Titusville.

SUMMARY:

Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. It’s a very exciting time to join our team as we lead the way in creating positive customer experiences!

As a BioPharmaceuticals Account Manager, you lead the promotion of our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local market and partnering to deploy approved services necessary to meet the needs of each account/customer. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas:

ESSENTIAL FUNCTIONS:

Business Planning & Account Leadership  - Ability to use digital tools and apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory effectiveness in competitive markets.

Selling  - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Engage with multi-disciplinary customers using a total office call approach to communicate value proposition of a new delivery method.

Customer Development  - Entrepreneurial mindset to gain access, build and maintain productive internal and external relationships through effective communication and collaboration based on customer needs and organizational goals.

Payer Access - Ability to grasp sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and communicates impact on product portfolio to key internal and external partners and effectively addresses payer access issues (Medicare, Medicaid, Commercial) using Lundbeck resources.

Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Demonstrates a clear and detailed understanding of the disease state and its impact on customers and patients including the full range of treatment options available.

Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA, and PDMA guidelines.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

• Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university
• 5+ years of Specialty Sales experience in Pharmaceutical, Biopharmaceutical, Biologics or Medical Device sales experience
• Ownership and accountability for the development and execution of a fully integrated account plans
• Self-starter, with a strong work ethic and outstanding communication skills
• Proven track record of consistent sales performance
• Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually
• Must be computer literate with proficiency in Microsoft Office Software
• Must live within 40 miles of territory boundaries
• Driving is an essential duty of this job; must have a valid driver’s license with a safe driving record that meets company requirements
• Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• Infusion/rare disease sales experience in both the Outpatient Infusion setting and Specialty Pharmacy channel with a strong understanding of pricing and reimbursement.
• Neurology experience specific to migraine
• Experience in both the medical or specialty pharmacy benefit market
• Experience working with high influence customers in physician clinics, integrated health systems, infusion centers and alternative sites of care
• Product launch or expansion experience, particularly in a new therapeutic class
• Strong analytical background, and experience using sales data reporting tools to identify trends
• Strong leadership through participation in committees, job rotations, panels and related activities

TRAVEL:

• Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner.

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $150,000 - $65,000 and eligibility for a sales incentive target of 41,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site . Applications accepted on an ongoing basis.

Why Lundbeck

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site .

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site .

Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify .

Territory:Orlando, FL- Neurology

Target area for territory is Orlando, FL - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Deltona, Orlando, Clermont, Winter Haven, Merritt Island and Titusville.

SUMMARY:

Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. It's a very exciting time to join our team as we lead the way in creating positive customer experiences!

As a BioPharmaceuticals Account Manager, you lead the promotion of our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local market and partnering to deploy approved services necessary to meet the needs of each account/customer. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas:

ESSENTIAL FUNCTIONS:

Business Planning & Account Leadership - Ability to use digital tools and apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory effectiveness in competitive markets.

Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Engage with multi-disciplinary customers using a total office call approach to communicate value proposition of a new delivery method.

Customer Development - Entrepreneurial mindset to gain access, build and maintain productive internal and external relationships through effective communication and collaboration based on customer needs and organizational goals.

Payer Access -Ability to grasp sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and communicates impact on product portfolio to key internal and external partners and effectively addresses payer access issues (Medicare, Medicaid, Commercial) using Lundbeck resources.

Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Demonstrates a clear and detailed understanding of the disease state and its impact on customers and patients including the full range of treatment options available.

Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA, and PDMA guidelines.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

• Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university
• 5+ years of Specialty Sales experience in Pharmaceutical, Biopharmaceutical, Biologics or Medical Device sales experience
• Ownership and accountability for the development and execution of a fully integrated account plans
• Self-starter, with a strong work ethic and outstanding communication skills
• Proven track record of consistent sales performance
• Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually
• Must be computer literate with proficiency in Microsoft Office Software
• Must live within 40 miles of territory boundaries
• Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements
• Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• Infusion/rare disease sales experience in both the Outpatient Infusion setting and Specialty Pharmacy channel with a strong understanding of pricing and reimbursement.
• Neurology experience specific to migraine
• Experience in both the medical or specialty pharmacy benefit market
• Experience working with high influence customers in physician clinics, integrated health systems, infusion centers and alternative sites of care
• Product launch or expansion experience, particularly in a new therapeutic class
• Strong analytical background, and experience using sales data reporting tools to identify trends
• Strong leadership through participation in committees, job rotations, panels and related activities

TRAVEL:

• Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner.

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $150,000 - $65,000 and eligibility for a sales incentive target of 41,500.Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis.

Why Lundbeck

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

#J-18808-Ljbffr

Job DescriptionJob Description

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Equity and and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families. 

Umoja Biopharma – Your Body. Your Hope. Your Cure. 

POSITION SUMMARY

We are hiring for an experienced Biopharmaceutical Data Scientist who thrives on turning data into actionable insights. The ideal candidate has proven statistical expertise across Analytical Development and Quality, driving critical CMC decision-making. They're passionate about using data to accelerate life-saving treatments and expanding their reach to patients who need them most. They excel at building reproducible data products and drive impact autonomously in a fast-paced environment.

This is a Contract-to-Hire position. This role is based out of our Louisville, CO location, although, exceptional candidates based in Seattle, WA may be considered.

CORE ACCOUNTABILITIES

Specific responsibilities include:

• Drive statistical strategies for process validation and comparability, including risk-based PPQ approaches and direct interface with FDA/EMA statisticians during regulatory reviews
• Lead statistically robust study design and analysis to optimize manufacturing processes, establish control strategies, and support regulatory submissions per ICH/FDA/EMA guidance
• Build and maintain reproducible data science communication products including interactive dashboards, analytic reports, and other deliverables that effectively communicate complex findings to diverse stakeholders
• Collaborate using Git workflows for version control and code management
• Bridge scientific questions and computational solutions by translating problems into statistical models and applying optimal methods for each application
• Collaborate closely with scientists on research themes that span a diverse set of topics from immunology and molecular biology to process development and manufacturing
• Adherence to GMP when demanded by the specifics of projects, including timely completion of relevant training as provided by Umoja.

The successful candidate will have:

• Graduate degree (PhD or MS) in Statistics, Biostatistics, Computer Science, Bioinformatics, or related computational field with 2+ years (PhD) or 5+ years (MS) of experience.
• Strong foundation in applied statistics, statistical modeling, and method selection
• Demonstrated experience in computational problem-solving within a scientific research setting.
• Track record of developing analysis pipelines and reports
• Experience in scientific collaborations within therapeutics development with an ability to translate between scientific and computational domains.

• Experience with manufacturing statistics (process variability, specification setting, quality metrics)

• Advanced proficiency in R or Python

• Practical experience with Git workflows

Qualifications:

• Familiarity with data engineering and basic cloud tools (AWS)
• Experience with:
  • Building and deploying interactive dashboards, reports, and other analysis dissemination tools using appropriate technologies (R Markdown, Jupyter notebooks, Shiny, Dash, streamlit etc.)

• Omics assays (transcriptomics, proteomics, single-cell analysis, flow cytometry)

• AI/ML application development

• Familiarity with immunology and immune cell biology
• Working understanding of molecular mechanisms in cancer and cell therapy
• Experience working in biopharmaceutical R&D
• Ability to self-motivate to identify high-impact initiatives and drive them to completion
• Thrives in multidisciplinary teams while independently determining what needs to be done
• Proactively identifies opportunities to improve and expedite projects and workflows

Physical Requirements:

• Ability to sit for prolonged periods of time
• Ability to work onsite at least 2x per week in our Louisville, CO (ideal), or Seattle, WA location.

Salary Range: $142,630 - $176,190

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma - Your Body. Your Hope. Your Cure.

POSITION SUMMARY

We are hiring for an experienced Biopharmaceutical Data Scientist who thrives on turning data into actionable insights. The ideal candidate has proven statistical expertise across Analytical Development and Quality, driving critical CMC decision-making. They're passionate about using data to accelerate life-saving treatments and expanding their reach to patients who need them most. They excel at building reproducible data products and drive impact autonomously in a fast-paced environment.

This is a Contract-to-Hire position. This role is based out of our Louisville, CO location, although, exceptional candidates based in Seattle, WA may be considered.

CORE ACCOUNTABILITIES

Specific responsibilities include:

• Drive statistical strategies for process validation and comparability, including risk-based PPQ approaches and direct interface with FDA/EMA statisticians during regulatory reviews
• Lead statistically robust study design and analysis to optimize manufacturing processes, establish control strategies, and support regulatory submissions per ICH/FDA/EMA guidance
• Build and maintain reproducible data science communication products including interactive dashboards, analytic reports, and other deliverables that effectively communicate complex findings to diverse stakeholders
• Collaborate using Git workflows for version control and code management
• Bridge scientific questions and computational solutions by translating problems into statistical models and applying optimal methods for each application
• Collaborate closely with scientists on research themes that span a diverse set of topics from immunology and molecular biology to process development and manufacturing
• Adherence to GMP when demanded by the specifics of projects, including timely completion of relevant training as provided by Umoja.

The successful candidate will have:

• Graduate degree (PhD or MS) in Statistics, Biostatistics, Computer Science, Bioinformatics, or related computational field with 2+ years (PhD) or 5+ years (MS) of experience.
• Strong foundation in applied statistics, statistical modeling, and method selection
• Demonstrated experience in computational problem-solving within a scientific research setting.
• Track record of developing analysis pipelines and reports
• Experience in scientific collaborations within therapeutics development with an ability to translate between scientific and computational domains.

• Experience with manufacturing statistics (process variability, specification setting, quality metrics)

• Advanced proficiency in R or Python

• Practical experience with Git workflows

Preferred Qualifications:

• Familiarity with data engineering and basic cloud tools (AWS)
• Experience with:
  • Building and deploying interactive dashboards, reports, and other analysis dissemination tools using appropriate technologies (R Markdown, Jupyter notebooks, Shiny, Dash, streamlit etc.)

• Omics assays (transcriptomics, proteomics, single-cell analysis, flow cytometry)

• AI/ML application development

• Familiarity with immunology and immune cell biology
• Working understanding of molecular mechanisms in cancer and cell therapy
• Experience working in biopharmaceutical R&D
• Ability to self-motivate to identify high-impact initiatives and drive them to completion
• Thrives in multidisciplinary teams while independently determining what needs to be done
• Proactively identifies opportunities to improve and expedite projects and workflows

Physical Requirements:

• Ability to sit for prolonged periods of time
• Ability to work onsite at least 2x per week in our Louisville, CO (ideal), or Seattle, WA location.

Salary Range: $142,630 - $176,190

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.

Senior Biopharmaceutical Data Scientist (Contract)

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma Your Body. Your Hope. Your Cure.

Position Summary

We are hiring for an experienced Biopharmaceutical Data Scientist who thrives on turning data into actionable insights. The ideal candidate has proven statistical expertise across Analytical Development and Quality, driving critical CMC decision-making. They're passionate about using data to accelerate life-saving treatments and expanding their reach to patients who need them most. They excel at building reproducible data products and drive impact autonomously in a fast-paced environment.

This is a Contract-to-Hire position. This role is based out of our Louisville, CO location, although, exceptional candidates based in Seattle, WA may be considered.

Core Responsibilities

Specific responsibilities include:

• Drive statistical strategies for process validation and comparability, including risk-based PPQ approaches and direct interface with FDA/EMA statisticians during regulatory reviews
• Lead statistically robust study design and analysis to optimize manufacturing processes, establish control strategies, and support regulatory submissions per ICH/FDA/EMA guidance
• Build and maintain reproducible data science communication products including interactive dashboards, analytic reports, and other deliverables that effectively communicate complex findings to diverse stakeholders
• Collaborate using Git workflows for version control and code management
• Bridge scientific questions and computational solutions by translating problems into statistical models and applying optimal methods for each application
• Collaborate closely with scientists on research themes that span a diverse set of topics from immunology and molecular biology to process development and manufacturing
• Adherence to GMP when demanded by the specifics of projects, including timely completion of relevant training as provided by Umoja.

The successful candidate will have:

• Graduate degree (PhD or MS) in Statistics, Biostatistics, Computer Science, Bioinformatics, or related computational field with 2+ years (PhD) or 5+ years (MS) of experience.
• Strong foundation in applied statistics, statistical modeling, and method selection
• Demonstrated experience in computational problem-solving within a scientific research setting.
• Track record of developing analysis pipelines and reports
• Experience in scientific collaborations within therapeutics development with an ability to translate between scientific and computational domains.

• Experience with manufacturing statistics (process variability, specification setting, quality metrics)

• Advanced proficiency in R or Python

• Practical experience with Git workflows

• Familiarity with data engineering and basic cloud tools (AWS)

• Experience with: Building and deploying interactive dashboards, reports, and other analysis dissemination tools using appropriate technologies (R Markdown, Jupyter notebooks, Shiny, Dash, streamlit etc.)

• Omics assays (transcriptomics, proteomics, single-cell analysis, flow cytometry)

• AI/ML application development

• Familiarity with immunology and immune cell biology

• Working understanding of molecular mechanisms in cancer and cell therapy

• Experience working in biopharmaceutical R&D

• Ability to self-motivate to identify high-impact initiatives and drive them to completion

• Thrives in multidisciplinary teams while independently determining what needs to be done

• Proactively identifies opportunities to improve and expedite projects and workflows

Physical Requirements:

• Ability to sit for prolonged periods of time
• Ability to work onsite at least 2x per week in our Louisville, CO (ideal), or Seattle, WA location.

Salary Range: $142,630 - $176,190

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.