Head of Gene and Cell Therapy Lab: Director

PPD   •  

Middleton, WI

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 53 days ago

Responsibilities:

  • · Act as the Head of GCT Laboratory and provide scientific leadership in analytical design and methods development during release and stability testing for GCT products.
  • · Recommend emerging technologies in the field of gene therapy. Identify and implement contemporary methods and technologies in support of GCT development goals.
  • · Make recommendations about product characterization assay development as requested for product development activities by Client programs.
  • · Inform, drive and oversee all technical aspects related to Quality Control requirements for compliance with cGMP regulations; develop Quality Control programmatic direction related to analytical development based on the feedback and relationship built with clients.
  • · Act as the technical leader and persuasive liaison to Clients, contractors and other stakeholders ensuring quality checks and release criteria for clinical materials for GCT programs.
  • · Implement, evaluate and maintain all IND/BLA based programs for cell therapy products for Phase I/II/III clinical testing and investigations.
  • · Serve as a liaison to senior management, cross-functional areas and external organizations such as Clients and support global regulatory agencies audits at PPD GMP sites.
  • · Develop and mentor a high-performing team of scientists with a vision of setting industry-leading scientific standard
  • · Create and drive the scientific strategy for analytics as a long-term value driver for GCT service to Clients.
  • · Lead a growing function that will require hands-on work to instruct and build the necessary skills within the group.
  • · Collaborate closely with Method Development and Validation (MDV) team to optimize methods, set specifications, investigate out-of-specifications, and provide impact for change control in the GMP environment
  • · Lead early and late stage analytical development method qualification and transfer for GCT products.
  • · Manage day-to-day group activities including timeline and budget management and objective setting and execution in a growing GCT analytical development group.
  • · Provide data analysis and review of method development, including stability-indicating methods and support the execution of stability studies for GCT products.

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Qualifications:


· PhD in immunology, cell biology, molecular biology or equivalent field with preferred working experience in GCT area.
· Minimum of 8-10 years directly related experience in biopharmaceutical development.
· Strong technical knowledge of viral assay development. Strong history of rigorous science applied to drive technical accomplishments.
· Knowledge in analytical method validation and global regulatory filing requirements.
· Demonstrated leadership capabilities to develop a high performing team, drive change and influence internal and external stakeholders.
· The ideal candidate will have an in-depth understanding and development-stage experience in biological potency method development, protein biochemistry and viral based products.
· Experience with characterization and quantitative analysis of complex biological mixtures utilizing state-of-the-art techniques, including, but not limited to sequencing, qPCR, and NextGen.
· Experience with cell-based and replication competent assays desirable.
· In-depth understanding of quality control laboratory operations in a commercial set up.
· Independently motivated, detail-oriented and good problem solving with ability and experience to troubleshoot complex technical and scientific problems.
· Strong ability to present data in a variety of team settings and actively participate in departmental meetings as well as cross-functional area project teams.
· Strong interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations.
· Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
· Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
· Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals.


Education and Experience:

· Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years) or equivalent and relevant combination of education, training, & experience.
· 5+ years of management responsibility
· Proven leadership skills

Knowledge, Skills and Abilities:

· Thorough knowledge of GMP or GLP
· In-depth knowledge of clinical laboratory science, ICH guidelines, FDA regulations concerning clinical labs processes in drug development process, method development, method validation, R&D, sample production and/or data processing
· Strong leadership skills including budgeting, forecasting and fiscal management
· Project and time management skills
· Excellent communication/interpersonal skills including presentation skills
· Demonstrated strategic planning skills
· In-depth global and cultural awareness
· Strong organizational agility and demonstrated drive for results
· Excellent coaching and mentoring skills

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