Skip to content

JobShark: Find the Right Job

Associate Director, Analytical Science and Technology

Devens, MA Full Time Posted by: Bristol-Myers Squibb Posted: Wednesday, 22 May 2024
 
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job.

But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: careers.bms.com/working-with-us.The Quality Control & Analytical Science (QC/AS) group is committed to supporting our global biologics analytical network with reliability, integrity, active engagement, and cross-functional collaboration. In addition to being responsible for the lifecycle management of commercial methods, QC/AS is responsible for creating and managing the analytical CMC strategies from late-stage development throughout the product lifecycle, validation strategy, authoring and reviewing regulatory filings, and supporting global QC and manufacturing technology groups.

The Method Lifecycle Group in the QC/AS department provides analytical oversight for the transition of programs entering the commercial space following clinical development, as well as commercial analytical method ownership and support.The Method Lifecycle Group is looking for an Associate Director to join the Global Quality Analytical Science and Technology team. The successful candidate will have a role in building and leading a team across the BMS Global Quality network and will also join a team which is responsible for the lifecycle management, CMC strategy, validation and technical transfer of separation methods (including transfer support, validation, and troubleshooting), and general and compendia methods support.

Duties/Responsibilities: Functions as technical leader for analytical technical line and leads a matrixed group of scientists with a broad range of experience.Serves as the point of a contact for BMS on the analytical strategy & technical leadership for Biological Product assets for the QC/AS organization within Global Quality.Defines technical strategy and writes/reviews associated documents to ensure global compliance for typical BioPharmaceutical's analytical methods including HPLC, Gel and Capillary Electrophoresis, Spectrophotometric and compendial methods.

Defines strategy that is scientifically sound, appropriate and incorporates industry and Health Authority best practices and expectations.Supports commercialized and late-stage biopharmaceutical products with a focus on establishing the analytical CMC strategy, enabling regulatory filings, providing technical partnership for quality control laboratories around the world, managing the life cycle of specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products.Partners with analytical development to achieve method readiness to initiate validation, write technical protocols, gather and interpreting of data generated by analytical development/QC labs and writes/reviews technical reports.

Supports methods' validation and transfers within and outside of BMS.Conduct periodic method validation and performance reviews and work with team leader to design and execute remediation experiments and implement changes to new or existing commercial methods.Role Requirements:PhD in biological sciences, chemistry or related scientific disciplines with > 10 yrs. relevant experience.

MS or BS with > 15 yrs relevant experienceIndustry experience in method lifecycle for the development and/or commercialization of Biopharmaceuticals.Demonstrated experience and in-depth technical knowledge of methods used for BioPharmaceuticals testing and characterization, validation, transfer and lifecycle of analytical methods used in late stage/commercial biologics process development and/or manufacturing environment.Hands on expertise in assays used to test and characterize biological products (eg, HPLC, UPLC, Gel and Capillary Electrophoresis, compendial methods, etc.).

Extensive familiarity with regulatory guidelines and cGMP laboratory processes.Experience working with colleagues at remote sites.Demonstrated skills in leading cross-functional strategic teams and collaboration with internal and external partners.

Comprehensive knowledge of biologics CMC regulations and working knowledge of cGMP requirements.Experience authoring/reviewing regulatory submissions.Demonstrated leadership capability (via direct supervision or leadership of matrix teams).

you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary.

Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

Devens, MA, USA
Science
Bristol-Myers Squibb
AJF/707491371
22/05/2024 00:41

We strongly recommend that you should never provide your bank account details to an advertiser during the job application process. Should you receive a request of this nature please contact support giving the advertiser's name and job reference.