GENERAL SUMMARY OF POSITION:
Under the general direction of the Director or designee, the Associate Director Process Development is responsible for leading cell line, media, and bioreactor process development activities to optimize MAb production processes and define process parameters, limits and ranges. This position provides technical guidance and leadership to process development staff; manages upstream process development projects; prioritizes group tasks and manages resources in order to meet organizational and departmental goals.
- Leads a team of scientists and research associates to optimize monoclonal antibody production in large scale culture.
- Provides technical and scientific guidance to team members.
- Collaborates with and supports Manufacturing, Product Discovery, and other groups within the organization to meet organizational objectives.
- Develops, scales up, and troubleshoots cell culture and primary recovery of monoclonal antibody products.
- Designs experiments, analyzes data, and draws conclusions.
- Ensures accurate and complete documentation of lab activities to ensure appropriate regulatory submission.
- Writes technical reports for tech transfer and regulatory submission.
- Evaluates productivity of cell lines, feed strategies, and process control parameters in bench-top bioreactors (1L) to pilot scale bioreactor (60L).
- Ensures the production of material for preclinical and toxicology studies.
- Develops media and feed formulations, optimizes bioreactor conditions, and demonstrates scalability of the processes.
- Develops and implements new technologies to streamline cell culture process development and manufacturing.
- Works with vendors to evaluate new technologies.
- Implements QbD (quality by design) approaches and utilize DoE (design of experiment) and metabolic modeling to optimize processes.
- Leads activities in bioreactor design, characterization, process monitoring and development of control strategies.
- Manages tech transfer to clinical production at 2500L bioreactor, lead scale-up and troubleshooting activities.
- Maintains substantial current knowledge of new technologies and innovations in the field of MAb cell culture and production.
- Works with senior leadership team to maintain an environment that fosters teamwork, collaboration, and innovation.
- Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provide guidance and direction to staff; establishes expectations, defining roles, supporting career development and managing performance.
- Works on problems of diverse scope where analysis of situation or data requires a review of complex data.
- Performs additional job related duties as required.
- Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Biochemistry, Molecular Biology, or other relevant field and a minimum of 5 years of relevant experience.
- Experience with large scale cell culture and bioreactor operations
- Demonstrated potential for technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
- Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
- Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
- Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills
- Excellent problem solving skills as well as time management and organizational skills.
- Proven ability to manage others, assign and schedule work, and conduct performance evaluations.
- Able to travel as needed
- Previous experience in a cGMP environment
- Experience with Design of Experiment (DOE) software
- Communicates with clients during CMO porgrams and works with project management to successfully meet program goals.
- Maintains substantial current knowledge of new technologies and innovations in the field for gene therapy.