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Showing 5000+ Analytical Development Scientist jobs in the United States
Job Description
The Analytical Development Scientist is responsible for performing laboratory testing on raw materials, in-process samples, and finished products, as well as supporting stability studies and validation activities for drug product development. This role operates in a cGMP environment and requires a strong understanding of pharmaceutical regulations and analytical best practices.
Key Responsibilities
-Perform routine analytical testing, method validation, and process validation in accordance with SOPs, cGMP, GLP, GDP, and regulatory guidelines (FDA, DEA, OSHA)
-Follow applicable compendial and regulatory standards for analytical procedures, method development, validation, and transfer
-Troubleshoot laboratory methods and instrumentation, including HPLC and UPLC systems
-Utilize Empower 3 software to analyze, interpret, and report analytical data
-Complete assigned work efficiently while maintaining a strong focus on safety, quality, and timelines
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: and Requirements
-Identify and troubleshoot issues related to analytical methods, instrumentation, or product quality beyond routine testing
-Maintain working knowledge of USP/NF standards, stability testing requirements, and validation processes
-Collaborate effectively within a team-oriented R&D environment
-Operate and maintain laboratory equipment such as HPLC, GC, dissolution systems, Karl Fischer titrators, UV/Vis, and FT-IR
-Demonstrate strong written and verbal communication skills
-Proficient in Microsoft Office (Word, Excel, Outlook)
-Able to work independently with minimal supervision
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Job Description
Job Description
This role focuses on performing analytical testing to support the development, validation, and control of raw materials, intermediates, and finished products in a regulated laboratory environment. The Analytical Development Scientist executes and optimizes analytical methods, maintains complex instrumentation, and ensures data integrity and compliance with GMP and applicable regulatory requirements. The position offers the opportunity to contribute directly to chemical development initiatives while working closely with cross-functional teams and external laboratories. Relocation to Iowa will be required!
Responsibilities
+ Perform analytical testing to support the development, validation, and control of raw materials, intermediates, and finished products.
+ Execute analytical assays using both established and newly developed methodologies.
+ Operate, troubleshoot, and maintain laboratory instrumentation, including HPLC, GC, GC/MS, LC/MS, FTIR, titrators, and particle size analyzers.
+ Set up, optimize, and refine analytical methods for compound identification, purity determination, and potency analysis.
+ Document all experimental work accurately and comprehensively in laboratory notebooks and formal reports.
+ Ensure strict compliance with GMP standards, standard operating procedures (SOPs), and applicable regulatory requirements, including those related to controlled substances (e.g., DEA).
+ Support the transfer of analytical methods to Quality Control and Process Support teams by preparing documentation, training materials, and technical guidance.
+ Coordinate external analytical testing with third-party laboratories, including sample submission and data review.
+ Generate, interpret, and analyze analytical data to support reference material qualification and other development activities.
+ Collaborate with internal teams to support Chemical Development initiatives and contribute to cross-functional project goals.
+ Perform additional laboratory duties and support tasks as assigned to ensure efficient laboratory operations.
Essential Skills
+ Hands-on experience operating and maintaining HPLC systems for analytical testing.
+ Proficiency with gas chromatography (GC) and mass spectrometry techniques, including GC/MS and LC/MS.
+ Experience using FTIR, titrators, and particle size analyzers in a laboratory setting.
+ Strong experience in wet chemistry techniques and analytical method execution.
+ Practical knowledge of GMP requirements and working in a regulated laboratory environment.
+ Ability to follow and develop SOPs and adhere to laboratory best practices.
+ Solid foundation in chemistry, including analytical and organic chemistry principles.
+ Experience in laboratory-based development activities, particularly related to APIs or chemical development.
+ Master's Degree in Chemistry with 2+ years of relevant industry experience, OR Bachelor's Degree in Chemistry with 6+ years of relevant industry experience.
+ Strong documentation skills with the ability to maintain accurate laboratory records and reports.
+ Ability to analyze and interpret analytical data to support development and qualification activities.
Qualifications
+ Master's Degree in Chemistry with 2+ years of relevant industry experience, OR Bachelor's Degree in Chemistry with 6+ years of relevant industry experience.
+ Experience supporting analytical method transfer to Quality Control or Process Support teams.
+ Familiarity with DEA or other controlled substance regulatory requirements in a laboratory setting.
+ Experience in API development or related pharmaceutical or chemical development activities.
+ Ability to work effectively in cross-functional teams and collaborate with internal and external stakeholders.
+ Interest in pursuing either a traditional scientist-level career progression or a technical specialist track.
+ Comfort working with multiple analytical platforms and adapting to new technologies and methods.
Work Environment
The position is based in a regulated laboratory environment with a standard Monday through Friday day shift schedule, totaling a 40-hour work week. Some overtime may be required to meet project timelines or support critical testing. The scientist will work as part of a larger team of approximately 25 colleagues, with a smaller sub-team of about 8-10 people for day-to-day collaboration. The laboratory uses advanced analytical technologies, including HPLC, GC, GC/MS, LC/MS, FTIR, titrators, and particle size analyzers, within a GMP-compliant setting. New team members receive comprehensive onboarding and mentorship to become proficient in the laboratory systems and regulatory expectations. The organization supports career growth through both traditional scientist-level progression and a technical track, with ongoing feedback and annual performance reviews to guide professional development.
Job Type & Location
This is a Contract to Hire position based out of Charles City, IA.
Pay and Benefits
The pay range for this position is $43.00 - $50.90/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Charles City,IA.
Application Deadline
This position is anticipated to close on Jul 24, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
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Analytical Development Scientist (HPLC)
Posted 20 days ago
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Job Description
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Analytical Characterization Development Scientist - LNPs
Posted 2 days ago
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Job Description
Full-time
**Company Description**
The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
If you're looking for a rewarding career, a place to call home, apply with us today!
**Job Description**
Eurofins is seeking a highly skilled, passionate, and motivated scientist to join our client Analytical Development team to support testing non-GMP samples for development studies such as comparability assessments, process development, stability, product, and process characterization.The Analytical Development team is responsible for developing and implementing new analytical methods, as well as optimizing and improving current methods for the characterization of raw materials, RNA drug substances, and LNP products and programs at various development stages.
+ Provide testing support for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and characterization of complex raw materials.
+ Collect, process, and analyze experimental data, ensure accurate and timely documentation in electronic laboratory notebook.
+ Review, interpret, and present data within the analytical team and cross-functionally.
+ Author, review, and revise technical source documents to support phase-appropriate comparability.
+ Provide technical oversight to guide analytical/QC investigations, as needed.
+ Actively collaborate with internal and external process development and quality teams.
+ Train and mentor junior team members as needed _._
**Qualifications**
**Basic Minimum Qualifications:**
+ B.S. in Analytical Chemistry, Biochemistry, Biophysics, or related field with 3-4 years of biotech industry experience utilizing HPLC, LCMS, or Capillary Electrophoresis
+ Proficiency with instrumentation such as Waters and Agilent LCs.
+ Proficiency with software systems such as OpenLab, Empower, and ELN (Benchling is a plus).
+ Previous experience developing methods for mRNA, gRNA, LNP, or lipids in general.
+ Familiarity with applicable ICH regulations and multi-compendial guidelines related to method validation.
+ Experience in assay development, qualification, validation, and transfer to GMP environments.
+ Ability to balance multiple responsibilities, prioritize activities, and navigate ambiguity.
+ Demonstrated learning agility, scientific problem solving, and strong written and verbal communication skills.
+ Proactive, creative, and positive attitude.
+ Unwavering commitment to safety protocols and procedures.
**Preferred Qualifications:**
+ Strong technical background on analytical methodologies using IP-RP, IEX, and AEX.
+ Experience working with various biophysical instrumentation such as GC, HIAC, and basic particle size characterization fluorescence-based assays.
+ Strong understanding of SEC-MALS analytical methodology.
+ Authorization to work in the United States indefinitely without restriction or sponsorship.
**Additional Information**
The position is **full-time, first shift, Monday-Friday** with overtime as needed. Candidates living within a commutable distance of **Boston, MA** are encouraged to apply.
**Excellent full-time benefits include:**
+ Comprehensive medical coverage, dental, and vision options
+ Life and disability insurance
+ 401(k) with company match
+ Paid vacation and holidays
+ Compensation: **$37.00-$41.00 per hour** based on education and experience
+ **\#LI-EB1**
**Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**
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Senior Analytical Development Scientist
Posted 18 days ago
Job Viewed
Job Description
- Develop, optimize, and validate analytical methods for the characterization of biologics, including proteins, antibodies, and vaccines.
- Perform routine and non-routine analytical testing to support drug development, formulation, and stability studies.
- Utilize a wide range of analytical techniques such as HPLC, UPLC, CE, MS, ELISA, SPR, and spectroscopy.
- Troubleshoot analytical instrumentation and method-related issues, implementing effective solutions.
- Prepare detailed analytical method development reports, validation protocols, and reports.
- Ensure all analytical activities are conducted in compliance with GMP, GLP, and relevant regulatory guidelines.
- Collaborate closely with formulation development, process development, and quality control teams.
- Contribute to the preparation of regulatory submissions (e.g., IND, BLA, NDA) with relevant analytical data.
- Mentor junior scientists and provide technical guidance.
- Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, or a related life science field.
- Minimum of 5 years of relevant industry experience in analytical development, preferably with biologics.
- Extensive hands-on experience with a variety of analytical techniques relevant to protein characterization (HPLC, MS, CE, SPR, etc.).
- Proven experience in method development, optimization, and validation according to ICH guidelines.
- Strong understanding of protein structure, function, and degradation pathways.
- Familiarity with GMP/GLP environments and regulatory expectations.
- Excellent problem-solving abilities and meticulous attention to detail.
- Strong written and verbal communication skills, with the ability to present complex data clearly.
- Experience in the **San Francisco, California** biotech cluster is highly valued.
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Analytical Development Scientist — Oligos & Small Molecules
Posted 6 days ago
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Job Description
#J-18808-Ljbffr
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Job Description
**Position Summary:**
+ **Work Schedule:** Monday-Friday, core hours 8am-4:30pm
+ 100% on-site (San Diego)
Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent's San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client's most challenging compounds.
The Scientist 3 in our Analytical Development group will lead analytical method development projects for small molecule, peptide, and amorphous drug products, with a strong focus on HPLC/UPLC stability-indicating methods, while ensuring GMP compliance and supporting analytical strategy, troubleshooting, and continuous improvement initiatives. The role combines hands-on laboratory work with potential supervision and mentoring responsibilities, as well as collaboration with QA/QC, customers, and cross-functional teams.
**The Role:**
+ Develop stability-indicating methods for peptide and small molecule API, intermediates, and drug products from scratch. Develops cleaning verification methods.
+ Perform and train others on a variety of analytical techniques including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, GC, USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, DSC, TGA, PSD, PXRD, SEM, hardness, and friability testing.
+ Troubleshoot and optimize analytical methods for characterization of drug products and intermediates
+ Perform qualification studies to determine if methods are suitable for transfer to Quality Control.
+ Communicate results both internally and externally through oral and written updates and formal reports as necessary. Lead discussions with clients on technical topics relating to their project. Supervisor will not need to attend most client meetings.
+ Exercise technical discretion and critical thinking in the design, execution and interpretation of experiments independently with minimal supervisor assistance. Data interpretation should be conducted independently.
+ Assist in the creation and/or revision of new department-wide and site-wide procedures and company SOPs.
+ Clear and accurate record keeping in laboratory notebooks and secondary review of other colleagues' work for scientific accuracy and compliance.
+ Collaboration with other departments to troubleshoot technical issues.
+ Individuals will stay abreast of current scientific technologies to maintain the state of the art nature of Catalent's services. Individuals will proactively communicate strategy to clients and work with their supervisor or BD to generate new proposals or change orders, as appropriate. Individuals will support the business aspects of their position by working with their supervisor to perform billing communication for all work proposals under their supervision.
+ Opportunity to hire, train and supervise 1-2 full time analytical group members and lab assistants
+ Other duties as assigned.
**The Candidate:**
+ 4 year degree in a physical, chemical, biological, or pharmaceutical science required
+ BS with 4+ years of experience required in analytical development.
+ MS with 3+ years of experience required in analytical development.
+ PhD with 1+ years of experience required in analytical development.
+ Physical Requirements: Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently
**Pay:**
+ The anticipated salary range for this role in California is $115,000 to $125,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
**Why you should join Catalent:**
+ Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.
+ Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.
+ Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
+ Several Employee Resource Groups focusing on Diversity and Inclusion.
+ Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment.
+ 152 hours of PTO + 10 paid holidays.
+ Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
+ Tuition Reimbursement - Let us help you finish your degree or earn a new one!
+ WellHub program to promote overall physical wellness.
+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
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Principal Analytical Development Scientist
Posted 19 days ago
Job Viewed
Job Description
- Lead the development, validation, and transfer of analytical methods (e.g., HPLC, GC, MS, spectroscopy) for raw materials, in-process samples, and finished drug products.
- Design and execute analytical studies to characterize drug substances and intermediates, ensuring comprehensive understanding of product quality attributes.
- Provide expert analytical support for formulation development, process validation, and stability studies.
- Troubleshoot and resolve complex analytical issues, ensuring data integrity and compliance with regulatory standards.
- Interpret analytical data, write comprehensive method validation reports, and contribute to regulatory filings (e.g., IND, NDA).
- Mentor and guide junior scientists, fostering scientific rigor and technical expertise within the analytical development team.
- Stay abreast of the latest analytical technologies and regulatory expectations, implementing innovative solutions.
- Collaborate closely with formulation, process development, quality control, and regulatory affairs departments.
- PhD in Analytical Chemistry, Pharmaceutical Sciences, or a closely related field.
- Minimum of 8 years of progressive experience in analytical development within the pharmaceutical industry.
- Extensive hands-on experience with a broad range of analytical techniques, including chromatography (HPLC, UPLC, GC) and mass spectrometry (LC-MS, GC-MS).
- Deep understanding of method validation principles according to ICH guidelines and regulatory requirements.
- Proven experience in developing methods for small molecules and/or biologics.
- Strong scientific leadership and project management capabilities.
- Excellent problem-solving skills and a meticulous attention to detail.
- Exceptional written and verbal communication skills, including the ability to present complex technical information clearly.
- Demonstrated ability to mentor and develop scientific talent.
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Analytical Development Principal Scientist
Posted 10 days ago
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Job Description
Job Description
The Analytical Development Principal Scientist develops, validates, and implements robust analytical methods for raw materials, intermediates, and finished pharmaceutical products, with a focus on small molecule active pharmaceutical ingredients (APIs). This role performs complex analytical testing using advanced instrumentation, supports method development and tech transfer activities, and collaborates closely with development and quality control teams to ensure data integrity and regulatory compliance. The Principal Scientist also mentors other chemists, contributes to continuous improvement initiatives, and plays a key role in scaling processes to commercial manufacturing within a regulated CDMO/CRO environment.
Responsibilities
+ Develop, validate, and implement analytical methods for raw materials, intermediates, and finished products, with emphasis on small molecule API development.
+ Perform analytical testing using HPLC, GC, GC/MS, FTIR, particle size analysis, and other relevant laboratory instrumentation.
+ Execute and support method development for compound identification, purity determination, and potency assays.
+ Interpret analytical data, draw scientifically sound conclusions, and document results in detailed technical reports and laboratory notebooks.
+ Ensure strict compliance with GMP, SOPs, DEA regulations, and other applicable regulatory requirements in all laboratory activities.
+ Transfer validated analytical methods to Quality Control and Process Support teams, ensuring clear documentation and effective knowledge transfer.
+ Advise internal and external stakeholders on analytical results, method performance, and technical transfer considerations.
+ Mentor and provide technical guidance to other chemists within the department, fostering skill development and best practices.
+ Support sample analysis for development projects, including planning, prioritizing, and coordinating external testing when needed.
+ Qualify reference standards, maintain accurate laboratory documentation, and uphold data integrity throughout all analytical workflows.
+ Maintain robust document control practices within a GMP environment, including assay records, method validation documentation, and quality control data.
+ Collaborate cross-functionally with development, QC, and manufacturing teams to troubleshoot analytical issues and support process optimization.
+ Contribute to continuous improvement initiatives in analytical development, laboratory operations, and documentation practices.
+ Demonstrate the ability to transfer processes to commercial scale manufacturing, ensuring analytical methods are suitable for production environments.
+ Participate in additional laboratory and technical support activities as required to meet project and organizational objectives.
Essential Skills
+ Extensive hands-on experience with HPLC, GC, GC/MS, FTIR, and particle size analysis in an analytical chemistry laboratory.
+ Strong experience in analytical chemistry and analytical development, particularly for small molecule API and Active Pharmaceutical Ingredient development.
+ Proven experience working within a CDMO or CRO environment and familiarity with associated operational and regulatory requirements.
+ Demonstrated expertise in GMP-compliant laboratory operations, including document control, assay execution, method validation, and quality control.
+ In-depth knowledge of GMP and DEA regulations and the ability to maintain compliance in all analytical activities.
+ Ph.D. in Chemistry or related field with a minimum of 8 years of relevant experience, or M.S. in Chemistry or related field with a minimum of 10 years of relevant experience, or a bachelor's degree in Chemistry or related field with 12 years of experience in a laboratory environment (pharmaceutical experience preferred).
+ Demonstrated ability to transfer analytical processes and methods to commercial scale manufacturing settings.
+ Excellent verbal and written communication skills, with the ability to clearly present technical data and collaborate across diverse teams.
+ Strong interpersonal and organizational skills, with the ability to work effectively in a diverse, cross-functional team environment.
+ Proven ability to maintain high standards of data integrity, documentation accuracy, and regulatory compliance.
Additional Skills & Qualifications
+ Ph.D. in Chemistry or related field with minimum 8 years of experience or M.S. in Chemistry or related field with minimum 10 years of experience or B.S. degree in Chemistry or related field with 12 years of experience in lab environment, pharmaceutical experience preferred.
+ Experience in API development and small molecule Active Pharmaceutical Ingredient projects within a regulated pharmaceutical environment.
+ Experience in method validation, including design, execution, and documentation of validation protocols and reports.
+ Familiarity with quality control principles, laboratory best practices, and continuous improvement methodologies.
+ Experience coordinating external analytical testing and managing relationships with third-party laboratories.
+ Ability to mentor junior scientists and chemists, providing technical guidance and supporting career development.
+ Strong problem-solving skills with the ability to troubleshoot complex analytical and process-related issues.
+ Comfort working within structured document control systems and following established SOPs in a GMP environment.
+ Pharmaceutical industry experience is preferred, particularly in development and scale-up of commercial manufacturing processes.
Job Type & Location
This is a Permanent position based out of Charles City, IA.
Pay and Benefits
The pay range for this position is $ - $ /yr.
PTO Holiday Pay Health, dental, vision insurance
Workplace Type
This is a fully onsite position in Charles City,IA.
Application Deadline
This position is anticipated to close on Jul 27, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
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Senior Analytical Development Scientist - CMC
Posted 19 days ago
Job Viewed
Job Description
Our client, a rapidly expanding pharmaceutical company, is seeking a highly skilled Senior Analytical Development Scientist to join their Chemistry, Manufacturing, and Controls (CMC) team. This crucial role, located in Richmond, Virginia , will focus on developing, validating, and implementing robust analytical methods for raw materials, in-process controls, and finished drug products. The ideal candidate will possess extensive experience in analytical chemistry techniques and a strong understanding of pharmaceutical development and regulatory requirements. This position offers a significant opportunity to contribute to the quality and success of our client's diverse product pipeline. You will work in a cutting-edge laboratory environment alongside a team of dedicated professionals.
Key Responsibilities- Develop and validate a wide range of analytical methods (e.g., HPLC, GC, spectroscopy, dissolution) for small molecules and/or biologics.
- Characterize drug substances and drug products, including purity, potency, identity, and stability testing.
- Troubleshoot and resolve analytical method issues encountered during development, scale-up, and commercial manufacturing.
- Support regulatory submissions by preparing and reviewing analytical data and method validation reports.
- Transfer analytical methods to Quality Control (QC) laboratories and contract manufacturing organizations (CMOs).
- Investigate out-of-specification (OOS) results and implement corrective and preventive actions (CAPAs).
- Stay current with advancements in analytical technologies and regulatory guidelines.
- Collaborate with cross-functional teams, including formulation, process development, and quality assurance.
- Mentor junior analytical scientists and contribute to the scientific growth of the department.
- Ph.D. or Master's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related field.
- A minimum of 5 years of experience in analytical development within the pharmaceutical industry.
- Proven expertise in developing and validating HPLC, UPLC, GC, and other relevant chromatographic techniques.
- Experience with various spectroscopic techniques (UV-Vis, IR, NMR) and wet chemistry methods.
- Strong understanding of GMP, ICH guidelines, and regulatory requirements for CMC.
- Experience with biopharmaceutical characterization (e.g., protein therapeutics) is a significant advantage.
- Excellent problem-solving abilities and meticulous attention to detail.
- Strong written and verbal communication skills, with the ability to document work clearly and concisely.
- Proficiency in data analysis software (e.g., Empower, Chemstation) and statistical analysis.
- Ability to work independently and as part of a team in a fast-paced environment.
Our client provides a competitive salary and an attractive benefits package. This includes comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, and generous paid time off. We encourage continuous professional development and offer opportunities for training and attending scientific conferences. Our modern facilities in Richmond, Virginia , are equipped with state-of-the-art analytical instrumentation, providing an excellent work environment. Join a company that is committed to quality, innovation, and the career growth of its employees.
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