Sr. Scientist Pharmacopoeia

Work Schedule

Environmental Conditions

Job Description

Sr. Scientist - Pharmacopoeia

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

ONSITE:

This is a fully onsite role based at our customers site in (insert location i.e. 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:

• 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.

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:

• 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.

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

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