Quality Control Scientist III Full-time

Quality Control Scientist III – Cell and Gene Therapy

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

Role is based onsite in San Francisco, CA and will support our Cell Therapy (CTx) business unit of Thermo Fisher Scientific. At CTx San Francisco, we accelerate advanced cell therapies for difficult to treat conditions, including cancer, rare diseases, and other illnesses, from a newly opened cGMP manufacturing facility. In this facility, Thermo Fisher Scientific offers customers process and analytical development capabilities, as well as clinical and commercial manufacturing services, for novel therapies derived from either a patient's cells or from a donor source.

The Quality Control Scientist III – Cell and Gene Therapy role performs critical tasks in support of the manufacturing of Clinical/Commercial phase Cell and Gene Therapy products. The successful candidate will be accountable for following Current Good Manufacturing Practices (cGMPs) and carrying out functions related to the bioanalytical testing of raw materials, in-process/intermediate samples, release, and stability samples. These support functions include, but are not limited to, protocol and procedure authoring, analytical method transfer and method qualification/validation, assay execution, data review, and report drafting.

What you will do:

• Provide support for QC Analytical by performing the following: providing technical input for analytical proposals, work statements, test methods, investigations, risk assessments and client inquiries.
• Interpret data in accordance with concepts of biology, microbiology, industry standards, site SOPs and policies.
• Participate in scientifically sound investigations/RCA for related quality events (OOS, deviation, etc.) and design/implement effective CAPA
• Ensure tasks are performed with a method of prioritization – interpret production schedules and complete tasks accordingly
• Identify deviations and aid in investigations. Work to complete documentation of deviations and quality events in appropriate systems
• Participate in client-facing exchanges, 1-1's, departmental tier meetings, and other meetings/seminars deemed vital to facilitate department needs
• Analyze data and make detailed observations to ensure product quality
• Present data in a coherent manner to various internal and external partners
• Ensure testing is performed in an accurate and timely manner to meet production schedule and project timelines
• Model strong leadership, personal accountability, integrity, and operational excellence

How will you get here?

• Minimum requirement of Bachelor's degree in biology, chemistry, or related life-sciences fields with 7+ years of experience in a regulated industry such as pharma and/or medical device manufacturing within a QC GMP laboratory performing analytical method transfers, method qualification/validation, and testing across various phases of pharmaceutical development.
• Master's degree with 5+ years of the aforementioned experience.
• Minimum 2 years prior experience in quality control within a CDMO preferred

Knowledge, Skills, Abilities:

• Highly qualified in flow cytometric method transfer, method validation protocol drafting, and performing flow cytometry-based methods following cGMP practices and aseptic technique
• Demonstrable understanding of applicable regulatory requirements (ISO, ICH, FDA, EMA and USP) as it relates to analytical method transfer, phase-appropriate analytical method qualification and validation, safety testing and drug product stability
• Experience with NC/CAPA system, Change Control, New Product Introduction, Customer requests and complaint management preferred
• Technical writing experience specifically with regard to analytical method qualification/validation protocols, test method and test record design, and analytical reports is required
• Able to work independently and as part of a team with limited supervision
• Ability to build, use, and interpret scientific tables, charts, and graphs.
• Participate and provide input on timelines, potential compliance issues and other related QC activities.
• Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
• Sound interpersonal skills and a keen ability to multi-task in a detailed environment
• Proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Quality Management System (QMS) software), including software programs generating reports and statistics.
• Work with diverse groups, guide teams through decision making, facilitate agreement, build collaborative relationships, and focus on customer needs.
• Apply experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
• Highly skilled in applying Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis
• Communicate articulately with colleagues within manufacturing, engineering, AD/PD and QC staff, to resolve technical issues and direct activities
• Detail oriented with the ability to clearly communicate in verbal and written form
• Proficient in MS Office (Word, Excel, Power Point, etc.) with a focus on protocol generation, data analysis and presentations

At Thermo Fisher Scientific, each one of our 65,000 outstanding minds have a unique story to tell. Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer.

We offer competitive remuneration, annual incentive plan bonus, healthcare, 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!

The salary range estimated for this position based in California is $90,900.00–$136,350.00. 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