Immunomedics, Inc. Morris Plains , NJ 07950
Immunomedics is seeking a Director of Validation to provide experienced, technical, and scientific leadership for process validation, equipment qualification, cleaning validation, technology transfer and process improvements at its Morris Plain, NJ site and at CMOs for monoclonal antibodies, fusion proteins, and antibody/protein biopolymer drug conjugates. Successful execution of this role requires a strong scientific and engineering approach, established expertise in upstream and/or downstream process development for therapeutic proteins, process characterization, process validation, and technology transfer experience. The ideal candidate has a track record of establishing mutual respect, trust, and close collaborations with internal and external organizations, and the ability to interact effectively at all levels. This position will report to the Vice President ofsmi Engineering.
Oversee and manage process characterization, process validation, equipment qualification, technology transfer, and CMO-based manufacturing of large molecules, including but not limited to monoclonal antibodies, fusion proteins, and antibody-drug conjugates in preclinical to late stage development.
Use sound scientific and engineering criteria to support the development of manufacturing processes, identify and execute process improvement/ optimization strategies, and ensure successful scale-up and technology transfer of biologic products.
Support product development teams by leading manufacturability assessments of preclinical material.
Identify appropriate CMOs and manage technology transfer to support scale-up and cGMP manufacturing.
Support regulatory interactions and contribute to content of regulatory documents as needed.
Collaborates effectively within Process Development as well as with Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs.
Evaluate opportunities for improving process robustness or reducing Cost of Goods through process optimization
Support development of 2nd generation processes for implementation post-approval
Lead or participate in Project and CMC development teams, as required.
Take leadership role in promoting technology development and continuous improvement to streamline biologics development in Immunomedics.
D. in biochemical engineering, pharmaceutical chemistry, biochemistry, or appropriate technical discipline with 9-12 years of industrial bioprocess development and manufacturing experience, including mammalian cell culture and associated downstream unit operations or M.S + 16 years of relevant experience.
Experience in working with monoclonal antibody, fusion proteins, and antibody conjugates is preferred, with demonstrated expertise in upstream and/or downstream process development and analytical expertise.
Proven experience in early stage biologics process development, manufacturing, process characterization and process validation.
Experience in supporting launch and commercial manufacturing.
Experience in the management of outsourced manufacturing/development activities at CMOs and ability to create strong relationship with external vendor to deliver against the milestones.
Familiarity with cGMP operations and working in an FDA regulated environment.
Proven technology transfer and scale-up experience, from development lab to cGMP manufacturing.
Experience with statistical methodologies such as DOE, process control charting, multivariate analysis
Experience with authoring and review of CMC sections for regulatory submission.
Ability to communicate and connect with all levels of the organization.
Strong project leadership, resource management, analytical and problem-solving skills.
Excellent written/oral communication skills.
Experience in the principles of quality by design (QbD) and quality risk management is preferable.
Ability to conduct performance/development reviews.