Sr. Scientist - Pharmacopoeia

Thermo Fisher Scientific•Boston, MA

36d•$90,000 - $100,000•Onsite

About The Position

Thermo Fisher Scientific'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.

Requirements

Bachelor's 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.
Deep knowledge of major pharmacopeial standards, including USP, EP, JP, ChP and other applicable global pharmacopeial requirements.
Experience interpreting pharmacopeial monographs, general chapters, and compendial requirements to support testing strategies, specifications, and product release.
Experience evaluating, planning, executing, and documenting the verification and/or transfer of compendial methods to Quality Control laboratories, manufacturing sites, and/or contract testing laboratories.
Experience initiating, authoring, assessing, and implementing analytical method-related change controls within an electronic or paper-based QMS.
Strong technical writing and communication skills, including the ability to author protocols, reports, technical assessments, method procedures, and change-control documentation.

Responsibilities

Serve as a technical subject matter expert for compendial analytical methods, including methods defined in the United States Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), Chinese Pharmacopoeia (ChP) and other applicable global compendia and testing guidance.
Evaluate the impact of pharmacopeial revisions, updated monographs, and revised general chapters on analytical methods, product specifications, and testing strategies.
Develop compendial method verification and transfer strategies, acceptance criteria, testing plans and technical documentation to support successful implementation at internal and external partners.
Initiate, author, assess, and implement analytical change controls in the applicable QMS, including impact assessments, risk assessments, and implementation plans.
Support investigations involving atypical results, out-of-specification results, deviations, method-performance trends, and laboratory events associated with compendial testing.

Benefits

competitive remuneration
annual incentive plan bonus
healthcare
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
short- and long-term disability
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