Bristol Myers Squibb ASSOCIATE SCIENTIST in Devens, Massachusetts
Global Biologics Stability (GBS manages the stability programs for all commercial biologic Drug Substance and Drug Products across internal and external manufacturing sites. The Associate Scientist reports to the Associate Director of GBS and is responsible for stability study generation. The Scientist may also assist with Stability Assessment and Strategy, Sample Management, Stability Data Evaluation and Trending, and Stability Data Reporting in accordance with cGMP and Company SOPs.
The role of the Associate Scientist is to perform activities related to the global stability studies. Activities include those associated with the Global Stability program and include authoring stability protocols and approving stability studies in LIMS.
MAJOR DUTIES AND RESPONSIBILITIES:
-Author and maintain Master Stability protocols and Batch specific protocols for all commercial biologic Drug Substance and Drug Products across internal and external manufacturing sites.
-Work with Quality Control (QC) to ensure timely and accurate study builds in LIMS
Participate and/or lead OpEx initiatives to streamline and standardize stability study generation.
Identify, Write and revise SOPs for managerial review and approval.
Escalate information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly and promptly to management.
Works according to cGMP requirements and HA expectations.
KNOWLEDGE AND SKILL
Minimum of 4 years (MS)/ 6 years (BS) relevant experience (biopharm or related Laboratory) at an Associate Scientist 1 Level (at BMS or other company). Knowledge of science generally attained through studies resulting in a BS/MS Degree or equiv. preferably in Biological Sciences.
Proficiency (or mastery) of at least one discipline (cell based Bioassay, Immunoassay, Separation technology [chromatography], Bioburden and Endotoxin, Stability, trending, Investigations); technical knowledge/SME in a technical discipline.
A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.
Excellent technical writing skills
Ability to work independently and collaboratively in a team matrix environment is required; promoting a high commitment to business goals and objectives.
-Proficient in software applications such as LIMS, SAP, SmartLab, Trackwise, and Microsoft Office applications, etc.
Proficient with US/EU stability requirements and industry best practices
Develops strategies for solving complex problems/issues with coaching.
- Associate Scientist may work on assignments that are extremely complex in nature where independent action and a high degree if initiative are required in resolving problems and developing recommendations.
- Associate Scientist work independently and assist with the creation of detailed instructions on new assignments.
- May have direct supervision duties. Associate QC Scientist will participate in training less experienced staff in normal operational tasks.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.