The Director of Product Development (API) reports to the VP Product Development and will be responsible for supporting the synthesis/manufacture of obeticholic acid as well as other Intercept portfolio compounds. This will include responsibilities for investigating optimizations for scale-up, synthesis improvements, and intellectual property opportunities. This role will also be responsible for the oversight for tech transfer, process validation and commercial preparedness of the manufacture of obeticholic acid in the US/North America. The preparation and writing of validation-related documents and key sections of regulatory documents (such as NDAs and INDs) are other requirements of the position.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
•Person-in-plant during tech transfer and process validation campaign(s) with manufacturing vendors in US/North America
•Responsible for reviewing and maintaining key documents related to process validation including batch records, deviations, change controls and batch release
•Responsible for oversight of plant operations and quick communication of issues as they arise
•Author Quality/CMC related regulatory correspondence and applications (NDA/MAA and IND) to support validation
•Partner with Intercept QA department to ensure that Intercept’s quality expectations are understood and acted upon by the drug substance vendor
•Identify and mitigate potential regulatory and quality risks for the drug substance manufacture and subsequent resolution of compliance and quality issues
•Identify and contract with collaborators or vendors for investigating opportunities for alternate synthetic approaches to obeticholic acid
•Work closely with the Intercept legal department to identify IP opportunities and the continued development of the patent portfolio around the API and its synthesis
•Work closely with Supply Chain to identify suitable options for the supply of key raw materials
•Determine requirements for capital expenditure for the future growth in API demand and develop long term plan for capital spends, including timing and key decision points
•Represent Product Development in interdisciplinary and technical project teams as needed
•Active participation in the selection, evaluation and approval of new third party contractors and suppliers for Product Development activities in the US
•Ensure adequate documentation processes and systems are available and followed for drug substance synthesis, testing and release (SOPs / Protocols review /approval)
•Assist with contract negotiations and budgeting for drug substance manufacture, testing and release
•Interact directly with other Intercept departments relating to project finances, Regulatory, Quality Assurance, and Safety
•Minimum PhD in organic chemistry
•Minimum 10 years experience in the pharma/biotech field, working in commercial and/or development manufacturing plant environments
•Strong knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory requirements (eg US, European, Japanese)
•Process validation and PAI experience preferred
•Ability to effectively organize and prioritize tasks to achieve established deadlines
•Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
•Detail-oriented, with good organizational, prioritization, and time management proficiencies
•A good understanding of current regulatory requirements and an ability to interpret new regulations and requirements in the product development context is essential
•Knowledge of GXPs, ICH guidelines, FDA and EMA/CHMP (and other international) regulatory requirement
•Ability to travel and be the person-in-plant at any US/North America manufacturing facilities, possibly for extended periods of time. Travel will mostly be within the US but may require some travel to the EU (Average travel expectations: <25%/year)
REQUIRED KNOWLEDGE AND ABILITIES:
•Strong verbal and written communication skills are essential.
•Excellent organization and multi-tasking skills.
•Exceptional interpersonal skills and problem solving capabilities.
•Proven negotiation skills.
•Ability to work effectively across a matrix organization.
•Ability to work independently and prioritize with minimal daily instruction.
•Ability to think strategically in order to improve current processes.
TO APPLY: Email resume and cover letter to firstname.lastname@example.org. Please reference “Dir, Prod Dev-API” in the subject line. Only candidates with requisite experience will be considered. No phone calls or drop-ins.