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Director, Cell Manufacturing Science & Technology

Director, Cell MS&T

 

SUMMARY

Key leadership role responsible for optimizing T-cell manufacturing for new patient therapies, enabling a deep understanding of T-cell processes and products, and driving implementation of cutting-edge technologies. 

 

RESPONSIBILITIES

  • Manage & lead a team of 10-15 people responsible for ensuring successful manufacturing of new cell products and existing product lines. 
  • Lead cross-functional teams to deliver optimized processes to global T-cell manufacturing venues.  
  • Develop an efficient manufacturing deviation root cause investigation and reporting system and establish effective corrective and preventive actions. 
  • Liaison with Manufacturing, Process Development, Quality Assurance, Quality Control, Regulatory, Clinical and various project stakeholders to promote Product Development aims
  • Manage process and product analytic strategy.  Oversee process analytics and data management for development, regulatory and clinical objectives. 
  • Drive innovation. Develop and implement tools, systems, and processes to identify and implement innovative cell manufacturing processes. 
  • Manage internal and external collaborations to attract key technologies.  Educate and train Adaptimmune team members and stakeholders on new technologies. 
  • Establish and lead teams to source, vet, qualify, and implement cell manufacturing equipment, supplies, reagents, infrastructure, and IT.
  • Effectively & efficiently communicate results internally and externally.  Prepare data reports for internal use, regulatory filings, investor publications, and scientific conferences.   
  • Participate in CMC leadership team to set annual objectives, manage global supply chain, optimize and improve manufacturing processes, and maintain state-of-the-art quality management systems

               

REQUIREMENTS

  • BS in Pharmaceutical Sciences, Physical Sciences or related Life Sciences, advanced degree desired
  • Minimum of 10 years of experience in biotech or pharmaceutical industry, preferably in MS&T with emphasis on immunological systems, cell therapy, gene therapy, and individualized patient therapies
  • Hands on experience with Drug Product manufacturing scale up, technology transfer, product process optimization & experience with RCAs and CAPAs
  • Thorough understanding of drug development and commercialization process including strong knowledge of cGMP regulations and/or clean room experience
  • Experience in authoring and reviewing documents for regulatory (FDA, EMA) review including IND, CTA, BLA and other regulatory filings
  • Experience bringing new products through development to commercialization
  • Experience working with human T-cells, primary human cells, immunological systems or similar biological systems
  • Must have excellent interpersonal & communication skills; strong customer focus required given the need to provide strategic insight to the CMC Leadership Team and integrate activities with CMOs, cross-functional partners and collaborative partners
  • Demonstrated leadership and teamwork skills
  • Experience with managing direct reports and leading teams of 5-15 people and/or leading project teams in a highly matrixed environment
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