Scientist Analytical Science amp Technology

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.

Position Summary

The 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 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.

Detailed Position 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.
Writes formal analytical documents such as validation protocols, method transfer protocols and investigations reports.
Conducts 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 methodsSupport 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
Interacts 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).
Participates in audits and interacts and answers questions from Heath AuthoritiesSupport 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 the 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 inspectionsPerforms general administrative and organizational activities.
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.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. May act as a deputy of the Manager for QC. Desired Experience Advanced knowledge and interpretation of cGMP
Intermediate understanding of analytical validation and technical transfer concepts andrequirements
Intermediate written and verbal communication skills
Intermediate problem-solving ability/mentality, technically adept and logical
Intermediate level interfacing with Regulatory Authorities and Contract Service Providers
Intermediate experience defending validation principles and processes in internal and externalaudits
Intermediate 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 ManufacturingPractice (GAMP) .
Basic ability to oversee external analytical service providers (i.e. raw data review, support service provider certification process)
Intermediate project management skills
Intermediate knowledge of laboratory and aseptic processes.
Ability to work independently, and/or lead and participate in team projects
Intermediate 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/sterility assurance, or pharmacopoeia interpretation/application Education and Experience:
BS Chemistry, Biology, Microbiology or relevant discipline
5 years of relevant work experience required, preferably in a Pharmaceutical environment.
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, or laboratory 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 hazardousequipment and cytotoxic product.
The incumbent must have the ability to pass an initial full physical exam, potentially including a respiratory certification with annual monitoring.
The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annual eye 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 of time.
The incumbent must be able to lift/carry NMT 25 lbs.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: R1527522_EN Updated: 2020-07-15 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.

Company info

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