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.
This position is part of Celgene’s new Biologics Manufacturing Team responsible for ensuring the robust execution of our Biologics in cGMP Manufacturing. The main responsibility is management of technology transfer projects which supports Celgene’s expanding early and late stage clinical pipeline. The individual will work closely with Biologics Development, Supply Chain, and Quality to ensure all aspects of technology transfer are successfully executed. In addition, the individual will be responsible for establishing systems to managing process information and for data analytics used for investigations and process optimization.
This position will also support the successful design, qualification, and startup of clinical cGMP manufacturing operations at Celgene. The individual will serve as a process equipment expert in equipment selection, will manage equipment qualification activities, and will be hands on solving issues during start up. Celgene’s evolving Biologics teams will allow for high throughput, highly productive cGMP manufacturing operations fueling a fast paced environment. This position offers an experienced individual a significant opportunity to establish best practices for technical support of cGMP manufacturing operations.
oLead cross functional technology transfer teams for internal and external cGMP manufacturing.
oTrack and coordinate project milestones related to raw materials, equipment readiness, analytical testing, process information, and manufacturing documents to initiate and complete batches per the production schedule.
oEnsure cGMP batch documentation allow the process to achieve the intended process control strategy. Ensure that the process is capable of achieving control limits and specifications
oInforms personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results.
oSupports the validation of processes and preparation for commercialization.
oInvestigate, identify root cause, and identify CAPA for manufacturing deviations.
oTrend process performance. Establish data analytics to serve as metrics, to assist in investigations, and as feedback to Process Development for scale up / process transfer.
oAuthor technical reports and protocols in support of cGMP activities.
oCoordinate sampling plans for GMP batches related to lot release, stability, and characterization.
oPartner with Process Development to ensure successful process transfer.
oCollaborate with Process Development on opportunities to improve process performance and cGMP operations.
oProvide technical leadership and manufacturing operations support; driving process, product, and operational improvements across the DS internal network and external manufacturing sites.
oAssist in equipment selection, qualification, and start up activities. Work with internal and CMO Manufacturing to ensure robust procedures are utilized for operation of equipment.
oBiochemical engineer, Chemical engineer, or Biochemistry background. Ph.D. with 3+ years experience or MS/BS with 9+ years experience in a pharmaceutical or biotechnology company.
oDemonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.
oExperience in biologics process development or cGMP manufacturing of biologic products.
oDemonstrated expertise in scale-up and process transfer for either cell culture/fermentation unit operations or protein/nucleic acid purification unit operations.
oExperience implementing biotechnology unit operations including fermentation, enzymatic reactions, chromatography, tangential flow filtration, and terminal filtration.
oExperience in single use bioprocessing technologies.
oProven track record leading and managing cross functional teams.
oKnowledge of data management tools and statistical process control
oExperience writing and revising standard operating procedures and batch production records
oExperience with operating and troubleshooting process equipment
oExperience working on late phase and commercial programs is a plus
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.