Senior Process Engineer Raw Materials

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.

Bristol Myers Squibb is developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.

We are looking for a Process Engineer III/Senior Process Engineer to join the Raw Material Team within the Cell Therapy Global Manufacturing Science and Technology (GMSAT) department. The successful candidate will collaborate with the GMSAT teams in Seattle and New Jersey locations in the US and support efforts related to tech transfer and life-cycle management. The Process Engineer III/Senior Process Engineer will be responsible for leading cross-departmental teams, planning/executing risk assessments and strategy development for analytical comparability exercises to enable change implementation. This role is responsible for creating raw material master plans, supporting/leading vendor change notifications, supporting dual sourcing strategies, and leading investigations. This role will also be responsible for supporting and developing designs and implementation of raw materials and single use equipment best practices and new designs.

Responsibilities include, but are not limited to, the following:


Collaborate with process engineers and analytical scientists by applying in-depth raw material and single use equipment knowledge to support CAR-T and viral vector manufacturing process teams

Lead execution of process risk assessments, development of criteria justifications, and development of raw material master plans

Support regulatory filings summarizing the strategy and results from comparability exercises

Develop, understand, and manage tools and templates that can be used to quantify potential impact of changes on process performance and product quality

Lead efforts focusing on alignment and harmonization of comparability strategies across multiple sites

Leverage and maintain strong relationships across multiple sites and vendors

Coach/support junior staff on the team on complex technical issues

Up to 25% travel may be required domestically (primary) and internationally (potentially)


Skills/Knowledge Required:


B.S. with 7 years, M.S./Ph.D. With 5 years with relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent with minimum 2 years of relevant experience in raw materials for cell/gene therapy, biologics or vaccines.

Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast paced matrix environment

Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment

Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes

Experience working in a GMP environment, familiar with ICH guidelines, and control strategy development

Excellent problem-solving skills

Proficiency utilizing MS Office products and statistical software (R, JMP, Minitab)

Able to creatively manage time and elevate relevant issues to project lead and line management

Strong scientific and technical writing

Detail oriented with excellent verbal and written communication skills


Additional Skills:


Preference given to candidates with experience writing regulatory submissions

Knowledge of raw materials and experience with complex products is preferred


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

Sign Up Now - MiamiCrossing.com