Senior Engineer - Sr Scientist, Biologics Manufacturing Ops - Drug Product
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.Senior Engineer - Sr Scientist, Biologics Manufacturing Ops - Drug ProductSummit, NJ
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.
The Biologics Manufacturing team within the Biologics Development and Manufacturing organization supports programs across all stages of clinical development and contributes directly to clinical and commercial process definition, tech transfer, GMP manufacturing, management and oversight of validation campaigns, mfg. launch planning and will provide post-launch technical leadership for drug product. The function is responsible for establishing and maintaining global technical capabilities network, utilizing external resources for manufacturing investigational and commercial products.
Working as a key member of the Biologics Development and Manufacturing organization, the candidate will be responsible to maintain a successful manufacturing network by contributing to technology selection, process design and optimization, technology transfer, batch manufacture, release, logistics and technical support. This position will have a heavy focus on establishing manufacturing science and technology and process engineering function within the drug product manufacturing group. Successful candidate will be a Drug Product manufacturing expert with experience in sterile product manufacturing, GMP operations and Biologics drug product unit ops ranging from drug substance storage, freezing/thawing, formulation, filling, lyophilization, visual inspection, and shipping for Biologics drug product in vials and syringes.
The Senior Engineer will be responsible to establish and lead manufacturing science and technology/process engineering function within drug product manufacturing.
- Will be responsible to maintain a robust supply chain by planning and executing GMP manufacturing campaigns
- Will act as technical expert for equipment qualification, manufacturing readiness, sterile products unit operations in GMP environment, and be responsible for troubleshooting manufacturing challenges
- Will conduct risk assessments/FMEA for mfg. processes, address deviations and implement CAPAs
- Will work closely with drug product development group to support manufacturing process development, process characterization and optimization, scale-up and technology transfer activities.
- Will be subject matter expert for primary packaging component engineering
- Will be responsible to implement operational excellence, lean sigma and continuous improvement to optimize existing and new processes.
SKILLS AND KNOWLEDGE REQUIREMENTS
- Ph.D. in Chemical Engineering/Pharmaceutical Sciences, with 5-6 years' experience in Pharmaceutical industry, or equivalent. B.S./M.S. with 7-9 years' relevant experience will also be considered.
- Subject matter expertise in sterile/biologic drug product manufacturing processes, equipment and unit operations from drug substance storage to secondary packaging is required. Expertise in primary packaging (e.g., glass, non-glass materials), device engineering aspects will be a strong advantage.
- Hands-on experience in working on mfg. floor and troubleshooting manufacturing issues is strongly desired.
- Experience in clean room technology and microbiology required.
- Advanced hands-on knowledge of statistics, data mining and trending for manufacturing process robustness analysis required including exposure to statistical software like Minitab, JMP etc.
- Experience in technology transfer and working with Contract Manufacturing Organizations (CMO) required.
- Experience in working in a cGMP environment required.
- Knowledge of operational excellence concepts, lean, six sigma desirable
- Demonstrated skills in project management and handling multiple projects simultaneously
- Strong written and verbal communication skills, good interpersonal skills, ability to multi-task, and a strong desire to learn, contribute and collaborate