Quality Control Scientist III

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, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Title: 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. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location / Division Specific Information

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.

Discover Impactful Work:

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.

A Day in the Life:

• 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.

Keys to Success: Education

• Bachelor’s degree in biology, chemistry, or related life-sciences field required.

• Master’s degree, or higher is preferred.

Experience

• 5 years of experience in a regulated industry such as pharma and/or medical device manufacturing required. Preferably within a QC GMP laboratory.

• Experience performing analytical method transfers, method qualification/validation, and testing across various phases of pharmaceutical development required.

• Master's degree with 3 years of the required experience.

• 2 years experience in quality control within a CDMO preferred.

• Experience with NC/CAPA system, Change Control, New Product Introduction, Customer requests and complaint management preferred.

Knowledge, Skills, Abilities

• 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.

• Ability to build, use, and interpret scientific tables, charts, and graphs.

• 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.

• Highly skilled in applying Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis.

• Detail oriented with the ability to clearly communicate in verbal and written form.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, 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.

Compensation and Benefits

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

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