Engineer I / 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.Engineer I / 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.
The Bioengineer I, Associate Manager will work within Biologics Manufacturing team and will be responsible for managing GMP-manufacture and operational matters pertaining to Celgene's investigational materials for therapeutic protein drug products. Working as a key member of the Biologics Development and Manufacturing organization, the candidate will be responsible to maintain a successful manufacturing supply chain by contributing to all aspects of manufacturing including process development, technology transfer, batch manufacture, release and logistics.
The successful candidate will manage the manufacturing and clinical supply chain for a range of therapeutic protein products in clinical development
- Will interface with CMOs, Quality, supply chain, development and other partners to effectively manage scheduling, manufacture, release and logistics of investigational materials to support clinical trials.
- Will work with teams and be responsible for mfg. site selection, process fit, request for proposal and business operational documents (CDAs, DSAs etc.)
- Will serve as subject matter expert for all aspects of manufacturing of sterile products e.g., vials, syringes.
- Will work with CMOs and development / Quality functions to lead technology transfer projects, support CMO deviation investigations, provide technical support to manufacturing, and interact with internal and external customers and stakeholders to support assigned projects.
- Will interact effectively with members of the Biologics Development and Manufacturing department, and with other Celgene stakeholders (Investigational Materials Supply Chain, Drug Product Development, Quality, Analytical Development/QC, Regulatory CMC, External Manufacturing organizations).
SKILLS AND KNOWLEDGE REQUIREMENTS
- BS/MS in Pharmaceutical Sciences, Chemical Engineering or Biological Sciences with 3-5 years' experience in Pharmaceutical industry, or equivalent. Ph.D. with 1-2 years' relevant experience and interest in a manufacturing and operations career will also be considered.
- Experience in technology transfer and working with Contract Manufacturing Organizations (CMO) required.
- Experience in working in a cGMP environment required.
- Exposure to clinical supply chain management preferred. Strong desire to learn operational aspects of drug product manufacturing and supply chain required.
- Familiarity with sterile/biologic drug product manufacturing processes and unit operations from drug substance storage to secondary packaging is required.
- Working knowledge of statistics, data mining and trending for manufacturing process robustness analysis desirable.
- Familiarity with Global regulatory, cGMP, cGLP, and ICH requirements.
- 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
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.