Bristol Myers Squibb Stability 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 Scientist reports to the Associate Director of GBS and is responsible for stability product strategy. The stability scientist determines stability product strategy for annual enrollments, process changes, and investigations. The scientist represents the stability function on Technical Product Teams. The Scientist may also assist with stability Study Generation, Sample Management, Stability Data Evaluation and Trending, and Stability Data Reporting in accordance with cGMP and Company SOPs.
MAJOR DUTIES AND RESPONSIBILITIES:
- Work in collaboration with Technical Product Teams, Global Regulatory Sciences, and manufacturing sites to develop stability product requirements for annual enrollments, process changes and investigations. Determine the stability requirements for each commercial product based on technical rationale and globally approved dossiers. Maintain a list of required yearly stability enrollments.
-Perform change control impact assessments and document the stability assessment in change controls. Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations or product shelf life extension.
-Represent GBS on laboratory and manufacturing investigation teams by performing stability impact assessments.
Participate and/or lead OpEx initiatives to streamline and standardize stability assessment.
Provide the technical requirements in a Master stability protocol, review and approve study specific protocols.
-Support stability data reporting as needed, which may include authoring or reviewing Health Authority submissions and responding to Health Authority Queries. Point person for global rollout of observations that may affect stability programs and develop strategies to close gaps/mitigation.
-Approve, identify, write and revise SOPs. Assist with development of company-wide Stability directives
-Act, escalate, identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly and promptly to management
-Identify and devise training need for ongoing stability activities. Ensure training requirements are met
-Works according to cGMP requirements and HA expectations.
Qualifications - External
KNOWLEDGE AND SKILL
-Minimum of - 2 years (PhD)/ 6-8 years (MS)/ 8-10 years (BS) relevant cGMP experience in biopharma at BMS or other company
- Knowledge and understanding of ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a biologics manufacturing facility.
-Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system. Ability to work collaboratively in a team matrix environment is required.
-Experience with evaluating and interpreting stability data using statistics and statistics software.
-Applied knowledge and good understanding of analytical and/ or Microbiology techniques including advanced assays in the fields of Cell Based Bioassay, Immunoassay, Separation technology (chromatography)/ Bioburden/ Endotoxin
-Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.
-Experience in Operational Excellence, with proven record of accomplishment in continuous improvement. -Prior experience with commercial stability trouble-shooting and demonstrated expertise in Biologics or Protein Therapeutic molecule
Works independently, review data and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy.- Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices; develops strategies for solving complex problems/issues; recommending and driving implementation of solutions. Use computer software/programs: Microsoft Office applications, SAP, LIMS, Trackwise, JMP, etc.
-Scientist works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
-Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
-Acts as an advisor to subordinate staff to resolve problems. Develops performance requirements and evaluates subordinates accordingly. Establishes and recommends changes to policies which affect subordinate organization.
-Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.
-Scientist receives assignments in the form of objectives and establishes goals to meet objectives.
Work is reviewed and measured based on meeting established objectives and schedules.
Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.
-Direct Supervision of Exempt/ non-exempt employees may be required
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.