Engineer Biologics Manufacturing

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Description:

We are currently looking for a Scientist/Engineer I/II to join our Biologics Manufacturing Team within the BMS Biologics Development & Manufacturing group in Summit, New Jersey.

As a member of the Biologics Development & Manufacturing group, the Sr. Scientist/Engineer I/II will provide technical and operational expertise and oversight to early stage clinical manufacturing campaigns. The focus of this position will be on upstream and downstream operations in single-use manufacturing environment. The ideal candidate should have expertise in upstream operations. Candidate with downstream operations experience, and adaptability or desire to work and learn upstream processes will also be considered.

As appropriate, responsibilities include but not limited to:


Support the build of internal operational capability for the disposable (single-use) clinical biologics manufacturing facility.
Champion full capability of equipment capacity and manufacturing operations to lead and support manufacturing operations. Function as a lead Supervisor during clinical processing.
Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
Adheres to the production schedule ensuring on-time, internal production logistics.
Records production data and information in a clear, concise, format according to proper GDPs.
Train new manufacturing operations staff.
Author manufacturing batch records, SOPs, material specifications, etc.
Lead technology transfers from Biologics Development and external partners to the Celgene's network. Technology transfer will include providing decisions for manufacturing implementation of processes and communicating the decisions to the technology transfer team.
Lead manufacturing investigations toward process impact assessments and ensuring timely completion and communications. Responsible for identifying appropriate CAPA(s) and implementation of them.
Support routine data trending of manufacturing data to fulfill regulatory/compliance requirements. This includes authoring various technical reports.
Actively pursue technical improvement projects and implement the changes through the global change control process.


Qualifications


Must be able to effectively switch priorities to and from hands-on manufacturing operations to technical operational build responsibilities.
Proficiency in biologics cell culture or purification operations.
Ability to work independently and lead a large cross-functional group.
Good communication and project management skills appropriate for leadership of technology transfer projects.
Comfortable analyzing scientific datasets/strong analytical skills with excellent technical writing skills.
Ability to work well in both individual and leadership capacities
Knowledge of cGMP, FDA/EMA regulations, Process Validation


Education


Biochemistry, Bioengineering, Biochemical, Chemical Engineering or related discipline: Preferred - BA/BS 6 - 8 yrs or MS and 3-5 in relevant experience in manufacturing operations of Biotech / Biopharm industry.


Working Conditions:


Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Physical dexterity sufficient to use computers and documentation.
Ability to lift up to 25 pounds.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Flexibility to don clean room garments and personal protective equipment (PPE).
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Company: Bristol-Myers Squibb

Req Number: R1526888_EN

Updated: 2020-07-01 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