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Director of Bioconjugation Research and Development

2 months ago

Philadelphia Pennsylvania, United States AL Solutions Full time
About the Role

We are seeking a highly experienced Senior Director, Bioconjugation to lead our Bioconjugation Development department. As a key member of our team, you will be responsible for managing key client account programs, overseeing research, development, and production operations related to ADCs and other conjugated products.

Main Responsibilities
  • Manage bioconjugation R&D, process development, and analytical method development groups within the bioconjugation development department.
  • Manage key client account programs and maintain strong and lasting business relationships, overseeing the bioconjugation development from project ideation, bid defense, assignment, progression, and completion.
  • Collaborate with the business development team to build a solid sales pipeline and have meaningful participation in all aspects of the business.
  • Lead the implementation, improvement, and use of company systems within the Bioconjugation development department, such as ELN, ERP, Chem Inventory, and training.
  • Oversee the Bioconjugation Development department operations and plan resources to successfully deliver client and company projects from project assignment to completion.
  • Manage technical input to GMP Batch Records and other Quality documents according to ICH and FDA guidelines.
  • Manage the technology transfer inputs of PD processes into the GMP manufacturing suite and provide support during GMP operations as needed.
  • Coordinate activities with QA/QC and Management for development of tox and GLP batches.
  • Development and qualification of analytical methods and instruments needed to support PD and later GMP manufacturing.
  • Partner with other departments on complex projects and collaborations.
  • Propose key strategies for challenging projects with innovative solutions.
  • Provide key leadership in the advancement of science and technology for the industry and business.
  • Mentor group leaders for team building and career advancement.
  • Perform at the highest professional standards.
  • Communicate effectively with supervisors, colleagues, and subordinates.
  • Direct the team members to comply with company's Safety/GMP/GLP/GDP guidelines and SOPs.
  • Participate as a team player in all aspects of the company business.
  • Keep up to date with EHS, cGMP, scientific, and technical developments.
  • Evaluation of lab practices for continuous improvement.
  • Provide assistance in laboratory design and process capabilities.
  • Evaluate the team performance.
  • Make hiring decisions through vigorous candidate screenings and interviews.
Requirements
  • PhD in Biochemistry or Bioengineering.
  • 10+ years of extensive experience in Bioconjugation.
  • A history working through Process Development, exceeding 10 years.
  • Hands-on knowledge working across the R&D space.
  • GMP Batch Review or a general understanding of the GMP space.
  • Antibody Drug Conjugate (ADC) experience is a requirement.