Bristol Myers Squibb Senior Research Investigator/Senior Research Scientist - Project Co-ordinator (PC) in Moreton, United Kingdom
Bristol Myers Squibb (BMS) has one of the richest biopharmaceutical pipelines in the industry. We discover, develop, and manufacture lifesaving and life altering drugs in cancer, hepatitis C, heart disease, and other therapeutic areas. BMS also has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.
The successful candidate will be part of the Analytical Regulated Testing GMP Team at BMS Moreton within Analytical Strategic Operations. The project co-ordinator (PC) provides strategy and oversight to analytical GxP activities to support clinical and commercial development for New Chemical Entities and Investigational Medicinal Products.
Position Responsibilities include but limited to:
Effective collaboration and co-operation as a key contributor to the Integrated Development Team ensuring all API and drug product release testing, stability testing and filing requirements meet associated clinical timelines.
Management of all analytical cGMP from Phase I through Registrational filing activities (e.g., method validation, release and stability testing, report authoring) for small molecule projects
Provide technical evaluation and feedback to internal development teams for methods transitioning from development into validation and cGMP analysis.
Provide technical expertise and troubleshooting for technical problems and investigations into anomalous results aiding in the identification of root cause and CAPA’s.
Critically evaluate and review regulatory filings including evaluation of data from collaborator labs.
Transfer of analytical methods to external BMS partners
Provides input into audit readiness and expertise for regulatory inspections.
PhD in analytical chemistry, organic chemistry, biochemistry or pharmaceutical development with more than 8 years relevant industrial experience or equivalent.
Demonstrated knowledge of evaluation and validation of chromatographic separation methods used to analyse API and drug product
Excellent interpersonal communication skills with capability of interfacing with and influencing multi-disciplinary teams.
Experience with regulatory submissions and interaction with regulatory agency inspectors.
Demonstrate a strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.
Demonstrates ability to prioritize project responsibilities to effectively assign and manage resources across the team to meet competing requirements.
Management of multiple projects effectively meeting timelines.
Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.
Ability to adapt to change, manage risk and operate in an ambiguous environment.
Able to identify opportunities to implement solutions to improve efficiency, productivity and quality.
Strong written communication skills to effectively communicate with key partners both internally and externally
Why should you apply:
You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
You’ll get a very competitive salary and a great benefits package including an annual bonus, pension contribution, family health insurance, annual leave, life insurance, on site gym and gain-sharing bonus.
Apply now by clicking the Apply button, or email me at email@example.com for more information.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
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.