QC Specialist - Biologics Stability

About the role

• Work Schedule
• Standard (Mon-Fri)
• Environmental Conditions
• Laboratory Setting

About the role

This is a fully onsite role based at our customer’s site in Foster City, CA We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies

Key responsibilities

The QC Biologics Stability Specialist will provide operational and technical support to the QC Stability Leads group in the execution of GMP-compliant stability programs. The role will analyze and trend stability data, generate stability summary reports, support regulatory submissions and shelf-life extensions, and assist with stability-related investigations and temperature excursion assessments.

The QC Specialist will also create and revise stability protocols, maintain program trackers and shipping forecasts, monitor material transfers, and collaborate with stability leads and cross-functional partners to ensure stability deliverables are completed accurately, compliantly, and on schedule.

The successful candidate will have experience with GMP documentation, biologics stability programs, data analysis tools such as JMP, and LIMS.

• Perform data analysis using JMP for quarterly trending and regulatory submissions.
• Generate Stability Summary Reports (SSRs) from LIMS for regulatory filings and inquiries, and Shelf-life extensions.
• Verify data for non-regulatory reports and support information gathering for stability-related investigations.
• Maintain and update molecule-specific stability trackers and shipping forecasts using Smartsheets and internal systems.
• Draft temperature excursion memos and initiate stability studies through protocol creation and revision.
• Populate and manage trackers for biologics programs and monitor material transfer reports.
• Collaborate with stability leads to ensure timely and compliant execution of stability program deliverables.

Education and Experience

• Bachelor's degree in lab sciences such Biology, or similar
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’)

Additional information

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Demonstrated experience in biologics Quality Control, including stability program support.
• Strong understanding of GMP principles and global regulatory standards.
• Proficiency in data analysis tools (e.g., JMP) and LIMS systems.
• Ability to develop and implement innovative solutions to complex problems.
• Excellent organizational, communication, and interpersonal skills.
• Proven ability to work independently and influence cross-functional processes.

Below is listed the working environment/requirements for this role

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

• 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!

Compensation and Benefits

The salary range estimated for this position based in California is $93,000.00–$98,000.00.

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