Sr. Scientist - Reference Standards Qualification

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting

Job Description

Sr. Scientist Reference Standards Qualification

Position: Hybrid

Shift: Full-Time; Monday Friday; 8am-5pm EST

ONSITE:

This is a fully onsite role based at our customers site in (Boston MA). 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 withoutsponsorship.

Must be able to pass a comprehensive background check whichincludes a drug screening.

At Thermo Fisher Scientific youll 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 Fishers 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:

• Support lifecycle management of reference standards assay controls and critical reagents including qualification bridging characterization stability monitoring inventory-related technical assessments and change implementation.
• Author and/or review protocols technical reports Certificates of Analysis (CoAs) comparability/bridging assessments and other GMP or regulatory-facing technical documents.
• Monitor analytical method performance through data trending assay control monitoring reference standard performance review and periodic assessment of critical reagent suitability.
• Collaborate with internal stakeholders and external testing partners to ensure timely execution documentation and review of lifecycle management activities.

Education and Experience:

• Bachelors degree in lab sciences such as Chemistry Biochemistry Material Science Immunology Biology Molecular Biology or similar
• Sr. Scientist: Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 4 years)
• OR Masters degree and previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years)
• OR PhD

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:

• Knowledge of relevant ICH and regulatory guidelines GMP requirements and expectations for analytical lifecycle management in a regulated environment.
• Experience supporting analytical methods for late-stage or commercial biological products including release stability and critical component testing.
• Hands-on or technical experience with reference standard assay control and/or critical reagent qualification bridging stability monitoring and lifecycle management.
• Strong technical writing skills with experience authoring or reviewing protocols reports CoAs SOPs assessments and regulatory-facing documents.
• Ability to interpret analytical data evaluate method/control performance conduct data trending and identify potential risks or performance shifts.
• Experience in cell and gene therapy biologics and/or CRISPR gene editing programs.
• Experience with assay control strategies reference standard replacement or bridging and critical reagent impact assessments.
• Experience with data analysis control charting and statistical tools such as JMP or similar software to support method performance monitoring.
• Experience with protein oligonucleotide molecular biology cell-based or immunoassay analytical techniques.
• Ability to prioritize objectives across multiple projects and meet timelines while maintaining flexibility and efficiency.

Working Environment:

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 Massachusetts is $95000.00$100100.00.

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: Experience:

Senior IC