Sr. Scientist

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose and Scope of Position

The Sr. Scientist is responsible for method transfers, method improvement, remediation, method validation/verification and/or troubleshooting of commercial products (API and drug product) within Quality Control laboratories. Serves as a Subject Matter Expert interfacing with Regulatory Agencies and Contract Service Providers as a technical expert. The Sr. Scientist is responsible for investigating commercial product complaints/issues at all manufacturing sites, domestic, international and Contract Manufacturing Organizations. The position requires proficiency working with small molecules or biologics in oral dosage and/or sterile injectables.

Required Competencies: Knowledge, Skills, and Abilities


Advanced knowledge and interpretation of cGMP
Advanced understanding of analytical validation and technical transfer concepts and requirements
Advanced written and verbal communication skills
Advanced problem-solving ability/mentality, technically adept and logical
Intermediate level interfacing with Regulatory Authorities and Contract Service Providers
Advanced experience defending validation principles and processes in internal and external audits
Advanced knowledge of international regulatory requirements (PIC/S, USP, Ph.Eur, JP, FDA(21CFR Part 11, 210 and 211), Annex 11 (EU-GMP), ICH, and Good Automated Manufacturing Practice (GAMP)
Intermediate ability to oversee external analytical service providers (i.e., raw data review, support service provider certification process)
Advanced project management skills
Advanced knowledge of laboratory and aseptic processes
Ability to work independently, and/or lead and participate in team projects
Advanced knowledge of Microsoft Word, Outlook, and Excel, Project, and Visio
Requires presentation development and delivery skills
Ability to gown and maintain a sterile work environment
This position will specialize in one of the following areas: chemistry, biotechnology, analytical validation, microbiology/sterile assurance, or pharmacopoeia interpretation/application


Duties and Responsibilities


Perform Validation of Analytical Methods or Tech transfer
Responsible for monitoring and managing the life cycle of assigned analytical methods.
Design and perform experiments to evaluate analytical methods associated with commercial products for feasibility, method improvement, remediation and/or troubleshooting.
Write formal analytical documents such as validation protocols, method transfer protocols and investigations reports.
Conduct analytical method transfer to internal and/or external commercial manufacturing/testing facilities.
Evaluate and participate in the review and implementation of compendia changes with impact to analytical methods.
Support laboratory investigations, deviations, CAPA's, Change Controls
Ability to troubleshoot method and/or equipment issues to the root cause
Capable of resolving non-routine laboratory issues and problems expeditiously
Interact with CSPs, reviews raw data generated by CSPs and supports their lab investigations as needed
Ability to write analytical method risk assessments or regulatory impact assessment statements (RIAS)
Participate in audits and interacts and answers questions from Heath Authorities


Support equipment, chemistry standards and controls


Participate in the selection/implementation of laboratory equipment and software
Participate in the management of global reference standards and controls (lifecycle for stability and routine usage)


Oversight of external Analytical Service Providers as appropriate


Support the approval and qualification process
Review raw data (QC peer review)
Participate in the inspection/audit at Contract Service Providers
Provide support to Service Providers during Health Authority inspections


Performs general administrative and organizational activities.


Provide scientific direction and oversees multiple projects within the team
Subject Matter expert for internal/external audits
Develop strategies for method transfer and implementation for new products and excipients
Perform QC oversight of commercial CSP's
Acts as functional area expert
Maintain qualification status on aseptic gowning, sterility testing, BET, etc.
Mentor and train junior staff members


The tasks above are project specific and may be initiated based on the scope of assignment and the individual's responsibilities

Performs other tasks as assigned

Education and Experience


B.S. Chemistry, Biology, Microbiology or relevant discipline
5 years of relevant work experience required, preferable in a pharmaceutical GMP envirnment
An equivalent combination of education and experience may substitute


Working Conditions (US only)


The incumbent may be required to wear uniform/PPE to work in a manufacturing, warehouse, orlaboratory environment.
The incumbent may be fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, etc.
The incumbent will have to perform work in a controlled environment with strict glove and gown requirements.
The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product.
The incumbent must have the ability to pass an initial full physical exam, potentially including arespiratory certification with annual monitoring.
The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annualeye exam is required.
The incumbent may be working in a laboratory setting up to 4 hours per day.
The incumbent will be required to sit at a desk and type/view a monitor for extended periods oftime.
The incumbent must be able to lift/carry NMT 25 lbs.


This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1527935_EN

Updated: 2020-07-23 00:00:00.000 UTC

Location: Phoenix,Arizona

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.

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