Location
Devens, MA, United States
Posted on
Apr 15, 2020
Profile
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The Stability Scientist is responsible for activities related to the global stability studies. Activities include protocol authoring, LIMS study approval, stability data evaluation and trending, authoring stability reports and stability sections of CMC regulatory filings. The stability scientist supports the Global Biologics Stability program for BMS and Third Party Manufacturers (TPM). The stability Scientist will also assist with Stability Assessments, Study Generation and Sample Management. Activities are performed in accordance with cGMP and Company SOPs and as requested by management.
MAJOR DUTIES AND RESPONSIBILITIES:
Execute stability program activities for the commercial biologic products. Author master stability protocols, stability study protocols. Evaluate stability study LIMS build for accuracy. Critically review stability documents for consistency and quality.
Work in collaboration with Global Regulatory Sciences, CMC teams and technical experts to author CMC stability sections of initial and post approval HA submissions.
Author site APQR/APR and end to-end APQR/APR and present the data at internal meetings.
Author ad-hoc stability filings and submissions. Respond to HA stability questions. Complete and close all stability studies.
Point person for global rollout of observations that may impact stability programs and develop strategies to close gaps/mitigation.
Approve, identify, write and revise SOPs. Assist with development of company directives
Data entry and verification in the electronic laboratory information management system (LIMS)
Support Health Authority inspections and internal inspections
Act, escalate, identify 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.
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), US/EU/ROW stability requirements, and industry best practices. 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 technical writing skills. Experience authoring CMC filing sections
Ability to work collaboratively in a team matrix environment
Experience with evaluating and interpreting stability data using statistics and statistics software
Applied knowledge and good understanding of analytical and/ or Microbiology techniques
Exhibit strong leadership and decision making skills. Develop strategies for solving complex problems/issues; recommending and driving implementation of solutions.
Experience in Operational Excellence, with proven record of accomplishment in continuous improvement.
-Prior experience with stability programs and demonstrated expertise in Biologics or Protein Therapeutic molecules
Works independently with a demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
Use computer software/programs: Microsoft Office applications, SAP, LIMS, Trackwise, JMP, etc.
Front room FDA/Inspectional experience is preferred.
DECISION MAKING
-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.
SUPERVISION RECEIVED
-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.
SUPERVISION EXERCISED
-Direct Supervision of Exempt/ non-exempt employees may be required
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
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.
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