Other Locations:US- NJ- Warren
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.
Specialist, Manufacturing Operations
B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 5+ years relevant experience in a laboratory setting. Experience in a supervisory or lead role is a plus.
Responsibilities will include, but are not limited to, the following:
- Act as a senior operator with supervisory presence in the production facility to guide and facilitate the manufacturing of products to support CTDO’s clinical and commercial timelines.
- Assume responsibilities as a lead operator for at least one product line, which includes serving as the primary GMP representative during early development and transfer activities.
- Leads the compliance efforts associated with at least two of the major areas of GMP compliance (i.e. Document Management, Batch Record Review, Nonconformance Reporting, Training, Facility Management, Equipment Qualifications/Maintenance, etc…)
- Responsible for systems maintenance, upgrades, and accuracy.
- Addresses related issues as necessary during internal audits.
- Promotes improvements in these areas to achieve greater process efficiencies.
- Assists with development, implementation, and deployment of training to new employees.
- Draft Standard Operating Procedures (SOPs) and/or production batch records associated with new processes that are transferred from Bioprocess Development into Manufacturing Operations
- Represents the department on cross-functional/interdepartmental teams tasked with complex projects
- B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 5+ years of relevant experience in a clinical laboratory or blood/cell culture processing environment or M.S. with 3+ years of relevant experience. Experience in a supervisory or lead role is a plus
- Ability to read and interpret documents such as safety procedures/rules and standard operating procedures (SOPs).
- Public speaking/ presentation experience
- Ability to work in an aseptic environment requiring successful completion of qualification program.
- A basic knowledge in various computer applications. Ability to work with Microsoft Word and Excel required. Understanding of Microsoft Access or database entry is preferred.
- Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials. Frequent visual demands require macroscopic and microscopic observations.
- Employees must work in areas where posted Universal Precautions must be observed and practiced. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or flammable chemical reagents and sharps.
- Able to communicate effectively with CTDO functional areas and external agencies.
- Fosters teamwork and promotes an environment that motivates others to achieve our goals.
- Responds to challenges and additional projects in an understanding, positive, and objective manner.
- Adaptable to dynamic conditions, work practices, and project timelines.
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.