Sr Scientist - Stability

Bristol-Myers Squibb Devens, MA

About the Job

Description:

Summary\:

Reporting to the Associate Director, Global BIOLOGICS STABILITY (GBS). The Sr. Scientist of GLOBAL BIOLOGICS STABILITY is responsible for activities related to the global stability studies. Activities include those associated with the preparation of CMC elements of regulatory filings of the Stability and project work to support the activities of the Global Biologics Stability program for BMS and Third Party Manufacturers (TPM). Sr Scientist GBS will also assist with Stability Assessment, Study Generation, Sample Management, Stability Data Evaluation and Trending and Stability Data Reporting generation and activities in accordance with cGMP and Company SOPs. as requested by management.

MAJOR DUTIES AND RESPONSIBILITIES\:
-Significant front room FDA/Inspectional experience on systems, QEs, LIMS, LES, etc.
-Lead the generation of Master stability protocol, Stability study protocol, LIMS stability build. Compile and author HA stability report, stability APQR/APR. Author HA stability submission section and provide response to HA stability questions. Complete and close all stability studies.  Act as expert on stability Root Cause analysis. Point person for global rollout of observations that may impact stability programs and develop strategies to close gaps/mitigation.
-Develop stability program activities for the current and new products. Generate master stability protocol, stability study protocol, stability APR/APQR. Oversee and evaluate stability studies LIMS build for accuracy.
-Approve, identify, write and revise SOPs. Assist with development of directives
-Work in collaboration with GRS CMC teams and technical experts.  Creates final drafts of Regulatory stability section documents for submission to GRS and onwards to global Health Authorities. Author stability reports in support of filings and amendments for approved products. Critically review stability documents for consistency and quality.
-Responsible for compilation and presentation of stability data at End to End (E2E) product meetings
-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
-Excellent in writing and reviewing of all Quality Approved documents including complex technical reports, CMC sections, Master Plans, Quality Agreements, etc.
-Works according to cGMP requirements and HA expectations.

Knowledge and Skill\:

-Expert Knowledge and understanding of ICH Guidelines (Q1A, Q5C) and associated BMS policies, directives and guidance documents
-Minimum of 4 years (PhD)/ 10 years (MS)/ 12 years (BS) relevant cGMP experience in biopharma at BMS or other company
-Expert level applied knowledge and in-depth understanding of analytical and/ or Microbiology techniques including advanced assays in the fields of Cell Based Bioassay, Immunoassay, Separation technology (chromatography)/ Bioburden/ Endotoxin
-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.
-Experience in interpreting and applying cGMPs, USP, ICH regulatory requirements and industry best practices 
-Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.
-Prior experience with commercial stability trouble-shooting and demonstrated expertise in Biologics or Protein Therapeutic molecule. Works independently on testing and methods including data review and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
-Expert 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 May routinely assess compliance status of stability program in partnership with management. Use computer software/programs\: Microsoft Office applications, SAP, LIMS, Trackwise, etc.


DECISION MAKING
Sr 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
-Sr Scientist receives assignments in the form of objectives and establishes goals to meet objectives.  
Provides guidance to subordinates to achieve goals in accordance with establishes policies.  
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
 

Qualification:

Knowledge and Skill\:

-Expert Knowledge and understanding of ICH Guidelines (Q1A, Q5C) and associated BMS policies, directives and guidance documents

-Minimum of 4 years (PhD)/ 10 years (MS)/ 12 years (BS) relevant cGMP experience in biopharma at BMS or other company

-Expert level applied knowledge and in-depth understanding of analytical and/ or Microbiology techniques including advanced assays in the fields of Cell Based Bioassay, Immunoassay, Separation technology (chromatography)/ Bioburden/ Endotoxin

-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.

-Experience in interpreting and applying cGMPs, USP, ICH regulatory requirements and industry best practices 

-Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.

-Prior experience with commercial stability trouble-shooting and demonstrated expertise in Biologics or Protein Therapeutic molecule. Works independently on testing and methods including data review and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy.

-Expert 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 May routinely assess compliance status of stability program in partnership with management. Use computer software/programs\: Microsoft Office applications, SAP, LIMS, Trackwise, etc.

DECISION MAKING

Sr 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

-Sr Scientist receives assignments in the form of objectives and establishes goals to meet objectives.  

Provides guidance to subordinates to achieve goals in accordance with establishes policies.  

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

 

Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers.