5,687 Process Development jobs in the United States

The Stanford Cancer Institute at Stanford University is seeking a Clinical Process Development & Manufacturing Professional 2 to independently conduct major portions of complex process development and clinical materials biomanufacturing consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the clinical trial investigational phase for treating patients with incurable diseases.

Duties include*:

• Lead human clinical materials biomanufacturing campaigns primarily as an operator. Prepare final formulated cellular products for clinical trials within production timelines and manufacturing schedules.
• Coordinate campaign activities with all functional teams: operations, quality systems, regulatory affairs, and business & administration.
• Train on biomanufacturing procedures, Batch Records or provide direction during process development activities.
• Plan and perform complex components of process development for technology transfer, scale-up/scale-out, optimization activities and characterization of new, state-of-the-art technologies in transition and translating pre-clinical, benchtop research into phase appropriate clinical trials.
• Plan and perform upstream and downstream components of assigned cGMP projects.
• Identify strategies for innovation in production systems and manufacturing processes.
• Identify operating excursions and facility deficiencies during manufacturing. Determine deviations and provide recommendations for Corrective and Preventive Action (CAPA) for Batch Records.
• Develop manufacturing budget including sourcing, identifying and ensuring qualified and verified raw materials for manufacturing; outline overall and per/patient costs for project materials and supplies and hours dedicated to complete all manufacturing steps.
• Determine need for, devise and revise Standard Operating Procedures and Batch Records.
• Oversee cGMP grade raw materials acquisition for biomanufacturing.
• Prepare and submit abstracts for publication in peer-reviewed journals and/or presentation at scientific conferences.

*- Other duties may also be assigned.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in related scientific field and two years of related experience, or Master’s degree, or an equivalent combination of education and relevant work experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong biological scientific background.
• Working experience with aseptic cell culture.
• cGMP clean room experience.
• Strong computer skills and ability to learn quickly and master computer programs, databases and scientific applications.
• Ability to work under deadlines with minimal supervision.
• Ability to maintain relationships and communicate effectively.
• Excellent organizational skills and demonstrated ability to complete detailed work.

PHYSICAL REQUIREMENTS*:

• Frequently sit, grasp lightly, use fine hand manipulation, repetitive pipetting, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.

*- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

• May require working in close proximity to blood borne pathogens.
• Ability to work under deadlines and meet/ exceed unpredictable manufacturing schedules.
• Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
• Position requires working in a cGMP clean room environment.
• Position may work with viruses: lentiviruses, adeno-associated viruses, and/or retroviruses.
• Position may work with human embryonic stem cells (hESCs).
• Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
• May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA Allergens/Biohazards/ Chemicals, and confined spaces, working at heights.
• May require extended or unusual work hours based on clinical manufacturing requirements and business needs. May be required to stay at work until product is released.

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors bases on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide, .

The expected hourly pay range for this position is $47.72 to $53.23.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( ) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Biologics Development & Launch: The department’s mission is to design, deliver and support the biologics manufacturing process for pipeline and partnered products through clinical development and commercial life cycle with quality, speed, and manufacturing excellence. This is achieved through a focus on targeted product quality, CMC acceleration, people development, and efficient workflows.

Cell Line Development Group: The CLD team utilizes state-of-the-art approaches and equipment to generate and characterize production cell lines for Biologics manufacturing. Team collaborates closely with other teams, such as Analytical Development, the Genomics Research Center, and Cell Culture Development.

Position’s key responsibilities will include:

· Execute experiments in cell line development and characterization with supervision.

· Extensive cell culture work – both directly and through coordination with the automation sub-team.

· Perform data acquisition and analysis in a timely manner.

· Assist in experimental designs, data interpretation and troubleshooting.

· Document work appropriately in lab notebooks, reports and presentations.

· Assist with lab operations and continuous improvement activities.

Minimum Qualifications:

· Must have completed bachelor’s degree in Biosciences or related field

· Extensive experience with aseptic technique and mammalian cell culture

· Microsoft software: Word, Excel, PowerPoint, Outlook

· Proven track record of teamwork, adaptability, initiative, and integrity

· Excellent interpersonal and both written & oral communication in English

Preferred Requirements (Optional):

· Experience with Flow Cytometry (e.g., analysis, compensation, sorting)

· Experience with Molecular Biology (e.g., recombinant DNA, vector construction, PCR, NGS)

· Experience with Electronic Lab Notebook system (ELN)

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job ID#

Recruiter-

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, located in Riverview, Michigan (Ash Stevens, LLC, hereafter referred to as PPS-Riverview), is seeking a qualified (Senior) Process Development Scientist to join our Process Development team. The PD Scientist is responsible for providing analytical support to the stability and reference standard programs.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skill and/or ability required:

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.

• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.

• Identify and protect the original technical information as part of the company property.

KEY RESPONSIBILITIES.

• Develop, conduct, and/or manage the process development of current and new synthetic/process pathways.

• Maintain communications with clients and ensure their requirements are met.

• Manage the production of new APIs. Ensure that adequate supplies of process materials (raw materials, solvents, reagents, etc.) and operation equipment (hoses, reactors, glassware, etc.) are available for assigned tasks.

• Ensure that product shipments meet customer and regulatory (FDA, EPA, OSHA, etc.) requirements.

• Write progress reports and provide technical support in meetings regarding current API production and new API process development.

• Ensure that approved processes are carried out according to cGMP guidelines and are properly documented.

• Keep Quality Assurance and Quality Control departments updated in regards to project/client requirements and schedules. Participate in the development, training, and transfer of new processes into the plant. Maintain accurate inventories of materials.

• Prepare appropriate reports as needed for management and/or clients.

• Maintain notebooks for research and development and non-GMP activities. Complete and audit production and cleaning records. Complete logbooks and documentation (dispensing record.

• BPRs, cleaning records, deviation reports, etc.) related to production and cleaning is accordance with regulatory requirements.

• Generate and/or evaluate standard operating procedures as required.

• Provide technical support for chemical operators, engineering, quality control, etc.

EDUCATION/EXPERIENCE.

• To be qualified as a Senior PD Scientist, a candidate must have: o PhD in Organic or Medicinal Chemistry and up to five (5) years’ experience in a relevant field; OR o MS in Organic or Medicinal
• Qualified candidates not meeting the above education/experience requirements will enter as a PD Scientist.
• Knowledge of organic chemistry and chemical safety.

JOB COMPETENCIES

• Excellent organizational and planning skills.

• Strong written, verbal, and interpersonal communication skills.

• Self-motivated, creative, and independent.

• Ability to direct projects covering a variety of chemical compounds.

• Familiarity with cGMP, plant safety, and EPA requirements.

JOB CONDITIONS.

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department.

Physical Demands:

o Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.

o Long periods of standing and walking can be expected in this position.

o This position may require long periods of sitting, typing, computer entry or looking at a

• Design and execute cell  culture  and purification  experiments at bench scale
• Support process development , characterization , and scale-up  for clinical drug substance manufacturing
• Analyze data, present findings, and contribute to regulatory documentation
• Drive technology innovation , including automation and continuous improvement

• Bachelor’s degree (or equivalent experience) in Biochemistry, Bioengineering, Chemical Engineering , or related field
• 1+ years of industry lab  experience  in cell culture  or protein purification
• Passion for learning and contributing across upstream and  downstream  development

• Lead and supervise up to 20 technical professionals in a fast-paced R&D environment.
• Provide technical guidance, mentorship, and professional development for team members.
• Oversee the design, planning, and execution of experiments to support process innovation and optimization.
• Align experimental design and development schedules with business objectives and customer requirements.
• Collaborate with plant operations and process engineering groups to ensure seamless technology transfer.
• Deliver technical support and troubleshooting expertise to chemical plant operations.
• Manage testing project timelines, resource allocation, and prioritization in a deadline-driven environment.
• Ensure compliance with safety, environmental, and quality standards in all development activities.
• Analyze data, guide team members in preparing technical reports, and present findings to stakeholders and senior leadership.
• Drive continuous improvement initiatives and foster a culture of innovation and accountability.
• Manage the R&D laboratory, including housekeeping, chemical inventory tracking, and asset accountability.

• Bachelor's degree in Chemical Engineering or Chemistry
• Master's or Ph.D. preferred
• 10+ years of chemical engineering process development experience, including 5+ years in leadership

• Strong project management skills; familiarity with stage-gate or similar development processes.
• Proficient in data analysis, experimental design, and technical reporting.
• Promote workforce safety; participate in Process Hazard Analysis and Pre-Startup Safety Reviews.
• Required PPE may include hard hat, hearing protection, safety glasses, safety footwear, respirator, rubber steel-toe boots, protective clothing, gloves, and other protective equipment as required.
• Work may involve extreme weather conditions (heat, cold, wind) in outdoor settings.
• Valid Driver's License to operate company vehicles.
• Work environment: open-pit mine or manufacturing/chemical plant with exposure to moving mechanical parts, toxic chemicals, electrical shock, explosives, fumes, or airborne particles.
• Must pass a full-face respiratory fit test and be able to work in PPE level C.