Head of CMC
CK Science are recruiting for a highly motivated and experienced Head of CMC to join a cell therapy biotech company, based in Boston, Massachusetts on a permanent basis. This is high profile position that will play a key role in the future success ofan innovative Immuno Oncology Biotech.
The Company: Based in Boston, this company is a fast growing and exciting Biotech. Using their own innovative technology, they are developing therapeutics Antibodies that will form the next generation of IOtreatments. You will be working with "World Class" scientists with a pedigree built from experience and credibility.
Head of CMC Role: The primary responsibility of this role will be to oversee the formulation and implementation of the company's pharmaceutical medium - and long-term R&D strategies and annual work plans, ensuring that the team completes tasks as planned.
Other duties will include to:
- Be responsible for pharmacological research and process scale-up in the pre-clinicaldevelopment stage of the company's innovative drug R&D project; production of samples for early clinical research; process scale-up, quality control optimization and process confirmation in the clinical research stage; technology transfer together with production and quality control departments before production of phase III clinical samples; technology transfer between external CDMO companies and inhouse workshops.
- Be responsible for the CMC part of the IND application materials and compilation of quality control materials for process changes during the clinical research.
- Cooperate with the engineering department to promote the construction of future pilot platform and production base; provide advice and suggestions on capacity design, plant design and equipment selection for commercial production of new products.
- Effectively carry out external technical cooperation and exchange activities.
Your Background: For the Head of CMC position, you should have the following skills and experience:
- Major in pharmacology, biology, analysis or related fields, doctor degree.
- Comprehensive and systematic understanding of cell culture, upstream/downstream process scale-up, protein purification, formulation development, quality control, etc., and expertise in at least two or three fields as above.
- Extensive experience in development of antibody/peptide drug CMC, with complete development experience in at least 2 macromolecule projects, including preclinical process development and scale-up, support of the IND applications in both China and America, and clinical drug production. (commercialized production experience in phase III clinical and NDA marketing is a plus).
- Familiar with relevant domestic and foreignregulations and guidelines, as well as GMP/cGMP/PICS management system.
- With a big picture and forward-looking attitude, capable of project evaluation, planning and execution, process management ability, systematic thinking and analytical ability, problem solving, communication and coordination skills.
- Extensive R&D management experience.
Apply: For more information or to apply for this Head of CMC position, please contact Jonathan Hart-Smith by email at firstname.lastname@example.org, quoting job ref 48887.
It is essential that applicants hold entitlement to work in the USA.