Scientist II Cell Therapy MSAT
Scientist II Cell Therapy MSAT
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$ 72000 - 108000
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)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 materialsJob 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
- 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 humanderived 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 multidisciplinary 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 forwardthinking 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 $72000.00$108000.00.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 longterm 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
Employment Type
Full-Time
Key Skills
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