Senior Scientist Development Operations Quality Control

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.

Purpose and Scope of Position

The Senior Scientist, Development QC role is responsible as single point of contact for all deviations, OOS, CAPA and training management. Additional responsibilities include, assisting in technical transfer activities from research to clinical QC and managing the general operation, workflow of the QC function. The candidate's responsibilities include, but are not limit to, creating technical protocols, reports, SOPs, risk assessments, and specifications.

Required Competencies: Knowledge, Skills, and Abilities


Advanced experience and knowledge of Compendial methods and requirements such as United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP)
Minimum of 5 years of QC experience or related GMP laboratory experience in the pharmaceutical industry.
Advanced ability to accurately and completely understand, follow, interpret, apply Global


Regulatory and cGMP requirements.


Advanced knowledge if investigation writing, CAPA and deviation management.
Knowledge of Sample Management and QC operations in a cGMP regulated environment.
Advanced knowledge of risk management and the proven ability to apply the concepts of risk management effectively.
Familiar with various analytical techniques including but not limited to: ELISA, qPCR, Flow Cytometry and scientific knowledge in the cell therapy product release field.
Able to perform responsibilities independently with minimal management oversight.
Advanced technical writing skills.
Advanced problem-solving ability/mentality, technically adept and logical.
Ability to represent the interests of the group on cross-functional teams.
Ability to work with management locally and globally.
Advanced ability to communicate effectively with peers, department management and cross- functional peers.


Duties and Responsibilities

Responsible for managing Development Operations QC Quality System records in compliance with company guidelines.


Ensures control of systems, processes and product through supporting the maintenance of a Quality System.
Ensures QC procedures and processes are maintained, adequate and efficient.
Leads and coordinates QC team member reviews of protocols and procedures.
Ensures deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implement changes in controlled documents.
Designs and/or implements and sustains Lean lab initiatives such as 5S, deviation reduction, right first time, permanent inspection readiness, visual management.
Provides oversight to risk management activities using FMEA.
Author SOPs, assay qualification, protocol, report and transfer and gap analysis reports.
Identify opportunities to improve technical and operational systems, practices, and technologies.
Comprehensive understanding of guidelines and can independently develop, write and execute method, protocols, reports, and other related documents.


Responsible for assisting in Development Operations QC sample management programs.


Collaborates with the QC Sample Management team and ensures GMP compliance of the laboratory area and operations under her/his responsibility.
Ensures the chain of custody of QC samples is maintained throughout the complete life span of samples including raw materials, bulk drug substances, packaging materials and stability samples


Drive and Manage projects within the group


Using technical expertise to troubleshoot and solve problems that may come up in the day to day operation of the department.
Participate on tech transfer QC teams for assay qualification of molecular and cell- based assays for cell therapy programs. Design and generate assay qualification protocols and reports.
Accepts responsibility for group projects; designs and executes experiments, analyzes


results, and writes technical summary reports.


Capable of handling complex issues and solving problems with minimal guidance.
Prepare and present continuous improvement projects to management.
Utilize advanced scientific principles to assist in analytical testing methods and the properuse of laboratory equipment.Carry out management authority for review and approval activities
Serve as author or technical reviewer of appropriate departmental procedures.
Review documentation as required by laboratory procedures.
Perform approvals for relevant laboratory activities.Provide Guidance and Leadership
Assist senior management with the development, implementation, and deployment of training.
Coach analyst on troubleshooting analytical methods and scientific equipment.
Teach junior scientists on theory and application of analytical methods.
Lead and develops best practices. Education and Experience
Bachelor's Degree required, preferably in Science.
Advanced Degree preferred.
5-8 years of relevant work experience, preferably in a regulated environment.
An equivalent combination of education and experience may substitute. Working Conditions
The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
The incumbent must analyze numerical values on a daily basis.
The incumbent will be working a laboratory setting up to six (6) hours per day.
The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.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. Company: Bristol-Myers Squibb Req Number: R1525713_EN Updated: 2020-06-15 00:00:00.000 UTC Location: Warren,New Jersey


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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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