Process Engineer I-II 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.

BMS is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. We are 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 I/II to join the raw materials team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The Raw Materials team is responsible for management of end to end raw materials including buffers, reagents, media as well as critical single use equipment and product contact equipment. This includes but not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation management, process improvements to support CAR-T therapies during late stage clinical, tech transfer, and commercial production.

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


Vendor management including change controls, audits, deviations, risk assessments and Quality Risk Management programs
Collaborate with raw materials development team for standards, best practices and early engagement.
Lead design optimizations, qualifications of materials, development and setting of specifications.
Support commercial production of CAR-T products through performance of proactive process monitoring of manufacturing processes related to raw materials to understand process capability, predict and mitigate shifts in performance, and identify process improvements.
Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
Provide necessary technical analysis to support impact assessments and investigations.
Share operational and process leanings with the rest of the manufacturing network


Basic Qualifications:


Process Engineer I: B.S. with 2-3 years or M.S. with 1-2 years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent with 1 year of relevant experience in raw materials for cell/gene therapy, biologics or vaccines.
Process Engineer II : B.S. with 3-5 years or M.S. with 2-3 years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent with 1-2 years of relevant experience in raw materials for cell/gene therapy, biologics or vaccines.
Experience with raw materials (liquids and single use) is required. Familiarity with cell therapy processes and cGMPs is strongly preferred.
Understanding of compendial requirements and how to assess specifications.
Experience working with vendors and contract manufacturing sites is preferred
Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
Excellent problem-solving skills, including issue resolution, root cause investigations and Corrective and Preventative Actions (CAPAs).
Ability to assess risk and develop contingency plans for process risks
Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
Able to manage time and elevate relevant issues to project lead and line management.
Detail oriented with excellent verbal and written communication skills.
Strong interpersonal and leadership skills to work with teams in different functions and organizations


Preferred Qualifications:


Experience with cell therapy process development and/or manufacturing
Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability
Lean Manufacturing experience is desired.


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.

Company: Bristol-Myers Squibb

Req Number: R1525762_EN

Updated: 2020-06-02 00:00:00.000 UTC

Location: Summit,New Jersey

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Sign Up Now - WashingtondcCrossing.com