Scientist / Engineer I, Biologics Manufacturing
Other Locations:US- NJ- Summit West
Celgene 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.Scientist / Engineer I, Biologics ManufacturingSummit, NJ
- 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.
We are currently looking for a Scientist/Engineer I to join our Biologics Manufacturing Team within the Celgene's Biologics Development & Manufacturing group in Summit, New Jersey.
As a member of the Biologics Development & Manufacturing group, the Scientist/Engineer I 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.
- 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
- 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.
- 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.