Senior Director of Operations

Senior Director of Operations responsible for the Process Chemistry function for a biologics/ADC contract development and manufacturing organisation (CDMO).

You will oversee synthetic route selection, development, scale-up, optimization and transfer of processes and methods for their cGMP manufacturing. You will partner with Analytical Chemistry, Discovery Chemistry, GMP Manufacturing and clients in the route screening, selection and development of new synthetic routes ensuring delivery of reliable and sustainable commercial manufacturing processes of synthetic drug substances throughout all clinical phases.

RESPONSIBILITIES:

• Manage key client account programs and maintain strong and lasting business relationships and oversee the chemistry process 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 business
• Lead the implementation, improvement and use of company systems within PD department such as but not limited to ELN, ERP, Chem Inventory, and training.
• Regularly evaluate process development and GMP manufacturing operations, developing, implementing recommended and/or necessary improvements and changes.
• Preparation and review of standard operating procedures (SOPs), batch records, standard work instructions, technical documents, reports, etc.
• Manage technical input to GMP Batch Records and other Quality documents according to ICH and FDA guidelines
• Manage the technology transfer of laboratory processes into the GMP manufacturing suite
• Coordinate activities with QA/AMD/QC and Management for development of tox and GLP batches
• Provide thorough documentation and authoring of lab notebooks, batch records, deviation, CAPA and technical documents.
• Develop practical and scalable synthesis routes for the manufacture of small molecule drug Manage the development of robust phase-appropriate syntheses for starting materials and intermediates.
• Participates in the strategic planning effort to helps shape corporate strategy as it pertains to accomplishing company’s goals
• Develops the company’s technical team through training and headcount growth, as appropriate
• Work with AMD to outline analytical methods needed to support GMP manufacturing
• Act as the representative between Process Development, GMP Manufacturing and the Quality Group for writing and approving batch records for GMP processes
• Keep up to date with EHS, cGMP, scientific, and technical developments
• Evaluation of lab practices for continuous improvement

QUALIFICATIONS:

• Ph.D. in chemistry, biology, biochemistry, or related discipline with 10+ years relevant experience in the pharmaceutical industry or M.S. in Chemistry or Chemical Engineering with 20+ years of ADC linker-payload process development experience.
• Extensive knowledge of USP, ICH, FDA, 21 CFR, and other guidance documents
• Experience in small molecule manufacturing and highly potent handling techniques
• Experience with common process scale crystallization techniques
• Experience with process scale medium-pressure and high-pressure chromatography development and scale-up
• Experienced with process safety evaluations, i.e. thermal stability analysis
• Experience in a GMP manufacturing environment
• Experience in process development
• Extensive knowledge of synthetic organic transformations, analytical and other technical abilities to successfully perform a wide variety of organic reactions
• Experience of purification using automated chromatography equipment (normal and reverse phase)
• The ability to prepare, review and execute GMP documents (Batch Records, SOPs, CAPAs, Change Control and Deviation Reports)
• Experience in scale-up/Process R&D and technical transfer