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Scientist III, Analytical Development (Cell Therapy)

Pharmaceutical Product Development (PPD)

San Francisco, California, United States of America

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

Location/Division Specific InformationWork Location: San Francisco, CA (on-site)

Group: Pharma Services Group

Division: Pharma Services Division

Business Unit: Advanced Therapies

Thermo Fisher Scientific has made a significant investment in the dynamic and rapidly growing Cell Therapy space. We recently opened a 44,000-square-foot, brand-new cell therapy collaboration center on the UCSF Mission Bay campus. The facility will serve as a central location where customers and UCSF researchers will have access to Thermo Fisher Scientific’s broad portfolio of solutions and clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support to UCSF and other partners. In the Cell Therapy group, we focus on providing development and clinical scale services for gene and non-gene modified cell processing for a variety of unmet medical needs.

How will you make an impact?

The Scientist III, Analytical Development, with mentorship, will apply technical skills to conduct experiments and studies to support our clients cell therapy needs and to assist in meeting the goals of the Cell Therapy group. Duties include collaborative planning, implementing, and troubleshooting experiments, and assisting with other lab activities as the need arises. This position entails experience and understanding of analytical design and development to establish new analytical methods and standard procedures for cell therapy product characterization. These functions may include but are not limited to activities such as handling and processing a variety of cell types, characterization using cellular and molecular assays (PCR and ELISA-based assays), FLOW cytometry, sterility and safety assays, technology transfer and design of technical documents.

What will you do?

  • Support multiple client programs having project oversight and direct and indirect report management responsibilities
  • Plan project scope, timing and resource requirements.
  • Design and develop analytical assays to support the clinical and commercial manufacturing of cell therapies including but not limited to FLOW cytometry, PCR/ddPCR, ELISA-based, and cytotoxicity assays
  • Design experimental plans based on the defined deliverables, planning the activities to meet the project timelines by working closely with project managers
  • Support the technology transfer of analytical methods to QC and assist QC with analytical method qualification and validation
  • Author and review technical documents such as methods, qualification/validation protocols and reports
  • Participate in project-team meetings (with internal and external partners). Present and discuss the data and project progress at those meetings.
  • Stay current with relevant technologies and scientific literature.

How will you get here?

Education

  • BS or MS in immunology, cell/molecular biology or similar biological sciences is required
  • Master’s degree in immunology, cell/molecular biology or similar biological sciences preferred
  • PhD in cell biology/molecular biology is ideal
  • Equivalent combinations of education, training, and relevant work experience may be considered

Experience

  • 5+ years of relevant cGMP experience in a manufacturing pharmaceutical/biotech environment, ideally within cell therapy
  • 4+ years of experience in immunology, cell/molecular biology
  • 4+ years of experience in analytical development of cell-based assays required
  • Aseptic cell culture processing (T cells, NK cells, CAR-T, or Stem Cells) in ISO 5 biosafety cabinets while using universal precautions for handling of human-derived materials preferred
  • Experience in viral or non-viral genetic modification would be preferred

Knowledge, Skills and Abilities

  • Understanding ‘why’ and not just the ‘how’ of processes and practices
  • Ability to drive safety, quality, functional, technical and operational excellence
  • Ability to work within cross functional teams and provide governance on project teams
  • Cell culture and aseptic techniques
  • Solid understanding of cGMP practices
  • Effective written, interpersonal, and presentation skills.
  • Excellent MS Office skills
  • Ability to travel up to 10%

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*.  Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

The salary range estimated for this position based in California is $110,000.00–$150,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs

  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement

  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Job posted: 2024-04-11

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