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Senior Director, Bioconjugation Development Lead
2 months ago
AL Solutions is seeking a highly experienced Senior Director, Bioconjugation Development Lead to join our team. As a key member of our organization, 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 to completion.
- 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.
- 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.
