Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.
At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.
Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.
We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.
The Associate Director, Cryogenics and Transportation Science develops and realizes strategies for frozen storage of protein drug substance, defines experimental methodologies to support the creation of a design space for cryogenics process steps and sets our technical strategy for cold-chain transportation. Responsibilities include leading an experimental group employing state-of-the-art Design of Experiments (DOE) approaches and formulating the in-process control strategy for cryogenics operations of late-stage processes.
The selected candidate will develop novel methodologies that enhance our current understanding of cryogenics processing and will establish business processes and technical rationale for our cold-chain biologics strategy. The position routinely interfaces with process development, cryogenics, analytical, supply-chain and quality leadership to achieve company-wide objectives. The successful candidate will work effectively in cross functional project teams and also independently to accomplish company goals. Responsibilities
- Scientific leadership and administration management of the Cryogenics and Transportation Science group, including laboratory activities. This team is responsible for validation of freeze/thaw (F/T) processes, successful implementation of F/T technologies and realization of the cryogenics platform strategy across the clinical and commercial pipeline. This includes 5 commercial molecules and an increasing number of clinical and late stage assets.
- Defines global strategy for managing and harmonizing the qualification of shipping lanes and drug substance (DS) containers, to support biologics operations for DS and Drug Product (DP).
- Develops and implements departmental safety culture, process and cost efficiencies, such as 5S.
- Interacts with global Health Authorities, during site inspections, contributing for regulatory responses, and briefing documents.
- Plans/ executes multiple projects/ initiatives to support Global Product Development and Supply operating objectives.
- Reviews and approves study designs, project milestones, experimental plans, technical documents and white papers.
- Recommends direction of cryogenics and transportation, science, investigations and technical transfer between DS and DP sites, drives justification of DS shelf life and defines best business practices across the global network.
- Establishes technical contacts outside the company, for example, connecting with external companies during technology evaluations.
- Position significantly impacts research, development and manufacturing in establishing and maintaining projects on schedule.
- Supervises and leads a major section of the department, the Cryogenics and Transportation Science group (4 FTE contractors). Plans and direct actions of the group.
- Collaborates globally with Supply Chain, Regulatory, Quality, Process Development, Engineering and Operations across internal and external DS and DP sites.
- Advisor to biologics operations senior leadership team, by presenting project direction, options and recommendations at key governance forums.
- Develops top talent with well-established succession plans.
- Leads teams and drives resources to deliver on business commitments and objectives, for example, implementing our overall Freeze/Thaw technology platform.
- PhD. in relevant scientific or engineering discipline (for example, biochemical/chemical engineering, pharmaceutical sciences), with 8 yrs directly related experience in the biopharmaceutical industry.
- Knowledge of protein formulation and stability is required. Knowledge of the effects of freezing and thawing on protein stability is desired. Knowledge of common protein analytical tools and demonstrated experimental skills for lab work is required.
- Knowledge of shipping qualification, transportation, and packaging design is desired.
- Demonstration of expertise in heat transfer is required.
- Candidates must possess excellent organizational skills and strong attention to details, proficient experimental/troubleshooting aptitude, be self-motivated and demonstrate a high degree of initiative.
- Experience with cGMP regulations, regulatory requirements, and CMC authoring for biologics processes are a plus.
- The candidate should also possess outstanding verbal and written communication skills, as well as excellent interpersonal skills with the ability to seamlessly in a multifunctional team environment.
Together, we make a difference. Bristol-Myers Squibb is one of the world's BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that's a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers .
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability