Scientist II, Cell Therapy MSAT

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Job Title: Scientist II, Cell Therapy MSAT
Location: Site Based: San Francisco, CA

The Scientist II, Cell Therapy MSAT leads activities related to customer process transfers and serves as backup process SME, reporting to the Manager, Cell Therapy MSAT.

Job Description

• Support technology transfer and implementation of new programs, with the objective to produce new clinical trial products within the facility
• Participate in customer core teams with other MSAT team members
• Troubleshoot activities for the production processes with the objective to guarantee that the product is delivered in time, and meets quality standards
• Optimize manufacturing processes with the objective to improve costs, speed and quality
• Implement new technology within the production facility
• Work with different functional groups to ensure timely completion of program deliverables
• Ensure timely completion of documentation packages for production scale processes, including, but not limited to:
• Applicable SOPs, Tech Transfer Master Plans, PFDs (including all disposable line builds for each program), Technology Transfer Protocols, Process Risk Assessments, and Campaign Summary reports
• Advise process development decisions with respect to facility fit and the manufacturability of development programs. Thereby, providing PD with the information required to develop fit for Suite/Site processes (i.e. raw material preferences, standard procedures, preferred operating methodologies)
• Maintain a customer and patient centric mentality to support technology transfer and batch execution
• Modify or improve procedures as required to streamline departmental processes
• Identify deviations, aid in investigations/root cause analysis/product impact assessment, and provide input on major/critical deviations
• Author Master Batch Records (MBRs) and review completed MBRs
• Demonstrate the highest example of safety and quality mindedness in all job functions

How will you get here?
Education

• BS or MS in biological science or engineering field
• Equivalent combinations of education, training, and relevant work experience may be considered.

Experience

• 2+ years of relevant cGMP experience in cell therapy Operations, MSAT, and/or Process Development
• Cell therapy manufacturing experience required
• Aseptic cell culture processing in ISO 5 biosafety cabinets while using universal precautions for handling of human-derived materials preferred
• Knowledge of cell therapy automation technologies, closed system culture vessels, cell washers, cell separation technologies for autologous/allogenic product manipulation required

Knowledge, Skills, Abilities

• Ability to drive safety, quality, functional, technical and operational excellence.
• Ability to encourage and champion innovation, collaboration, visibility and team efficiency.
• Ability to drive Customer Experience and a Commitment to Excellence.
• Ability to work across departments and provide governance on project teams
• Understanding 'why' and not just the 'how' of processes and practices
• Proven understanding of cGMP practices
• Deviation investigations, root cause analysis, and risk assessment
• Cell culture and aseptic techniques
• Recognition of problems developing, not just occurring
• Effective written, interpersonal, and presentation skills.
• Ability to work on multiple projects simultaneously
• Expert knowledge of mammalian cell culture
• Leadership of people in multi-disciplinary technical and scientific teams
• Knowledge of regulatory guidelines: EU, US, Australian, ICH, etc.
• Leader in Operational Excellence
• Ability to travel up to 20%
• Excellent MS Office skills

Environmental Conditions

Able to lift 40 lbs. without assistance. Adherence to all Good Manufacturing Practices (GMP) and Safety Standards. Cleanroom gowning: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. are allowed. Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), May work with hazardous and/or toxic materials.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, 401k, and a range of employee benefits!

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

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

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Compensation and Benefits
The salary range estimated for this position based in California is $72,000.00-$108,000.00.

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