Downstream Manager

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position: MANAGER – MANUFACTURING SCIENCES & TECHNOLOGY DOWNSTREAM

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. 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.

POSITION SUMMARY:

The manager in the Manufacturing Sciences and Technology Downstream group serves as technical lead and people manager in the areas of purification and primary recovery, including mixing, chromatography, viral clearance, ultrafiltration/diafiltration, filtration, formulation, and primary recovery unit operations, for late-stage and commercial manufacturing of biologics drug substance.

The successful candidate will serve as a people manager leading a highly technical, diverse, and collaborative team of scientists and engineers to meet highly visible business objectives. Deliverables include manufacturing process support and optimization, process technology transfer and validation, submission of regulatory filings, and driving continuous process improvements through new technology implementation and advanced process analytical technologies.

Responsibilities:

The successful candidate will lead a team of downstream SMEs by setting appropriate objectives and priorities, and delivering results within project timelines while maintaining an effective network across Manufacturing, Manufacturing Support, Process Development, Quality Assurance, Analytical, and Global Regulatory Sciences groups.

Provides technical leadership and expertise for the investigation and resolution of downstream process deviations in the Large-Scale Cell-Culture and Single-Use Facilities at Devens, MA through the effective design of bench and pilot scale-down studies and the evaluation of data from manufacturing lots.

Provides technical expertise for leading investigations through root-cause analysis, corrective and preventative actions (CAPA), process improvements, and scale-down model development.

Leads the design and execution of experiments in mixing, chromatography, viral clearance, ultrafiltration/diafiltration, filtration, formulation, and primary recovery unit operations. This position is based at the Devens site and may provide technical support to other sites within the manufacturing network. Technical support of drug substance handling and cryogenics deviations at Devens may be required.

Supervises authoring and review of technical documentation, including validation protocols and reports and change impact assessments.

Lead process characterization and initial scale-up for intensified processes and integrated analytical technologies in collaboration with Process Development, Analytical, and Operations groups.

Provides subject matter expertise, representing the Downstream function at the Devens site, during regulatory inspections and queries from health authorities.

Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures.

Qualifications:

PhD, MS or BS in Chemical/Bio Engineering, Biochemistry or related field with 4, 8, or 10 years of relevant experience in downstream process development or manufacturing science in the biopharmaceutical industry.

Strong scientific skills and process development experience working with biologics.

Proven project and people management skills to effectively lead cross-functional teams.

Experience with regulatory submissions and tech transfer.

Excellent oral and technical writing skills.

A passion to invest in people through assignment of development opportunities and coaching

Interpersonal and facilitation skills are necessary to interface with and influence across levels of the organization

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.

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com