Senior Director/Director, Product Development

This individual will lead small molecule solid oral formulation development and manufacturing for early to late phase clinical studies and commercialization. He/she will oversee formulation and process development, scale-up and optimization, and validation activities in-house and at external contract development & manufacturing organizations (CDMOs) and support all US and Ex-US regulatory filings. He/she will work cross-functionally and provide guidance and support to internal groups such as business development, marketing, clinical, analytical, process chemistry, quality, regulatory, preclinical, and discovery research as well as to external groups such as CDMOs to ensure that drug products are developed and manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP, GMP, ICH). He/she will provide strategic input and risk assessments and oversee preparation of CMC regulatory submissions and interact with regulatory agencies. This individual will also select, develop, and evaluate personnel to ensure the efficient operation of the function.

RESPONSIBILITIES:

• Develop and recommend pharmaceutical development, manufacturing and regulatory strategies.
• Overall responsibility for leading all drug product (DP) development activities transitioning from preclinical development to clinical development through clinical trial material (CTM) supplies for clinical phase studies and eventual transition to commercialization.
• Design and develop optimal dosage formulations and robust, scalable and cost-effective processes for the manufacture of DPs for clinical studies and commercialization.
• In collaboration with other functions identify, select and manage CROs and CDMOs for development, manufacturing and supply of DPs.
• Review and evaluate Manufacturing Batch Records for DP manufacturing to ensure all approved procedures were followed. Assist during quality events (QEs) or failure investigations and implementation of CAPAs at contractor sites.
• Author/review/approve CMC regulatory documentation for IND, NDA and IMPD filings, covering all phases of clinical development in both the US and ex-US markets.
• Create and communicate a clear vision among direct reports, motivate the team and effectively align resources to achieve corporate goals.
• Establish development plans, departmental goals and budgets for multiple projects.
• Ensure timely completion of high-quality technical reports/protocols and integrated cross-functional reports and/or strategy documents.
• Provide guidance in the selection of drug molecules with optimal biopharmaceutical properties, polymorphs and salts.
• Support preclinical team in the production of optimal preclinical formulations and preparation procedures for toxicology and DMPK studies in-house and at contract research organizations (CROs).
• Identify, manage and coordinate other outsourcing activities when appropriate.
• Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development
• Represent department and present work at interdepartmental meetings
• Assist and advise the Technical Operations Leadership as required. Provides recommendations and input on department policies, new product opportunities, product development strategies, procedures, resourcing, budgets, goals and objectives.

REQUIREMENTS:

• Doctoral (Ph.D.) or Masters (M.S.) in Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related scientific field, plus 15 years related experience, or BS +18 or more years' experience
• Extensive management experience (12+ years) with GLP and cGMPs, worldwide regulatory requirements and current industry practices
• A minimum 10 years of management/supervisory experience, and proven ability to work collaboratively and communicate effectively on a multi-disciplinary team.
• Significant experience in a variety of IR/MR solid oral dosage forms development and manufacturing is a must, knowledge in parenteral dosage forms is a plus.
• Substantial experience in successfully managing CDMOs for the manufacture of drug products for Phase 1 through Phase 3 clinical studies and commercialization.
• Extensive experience in preparing and maintaining regulatory submissions (IND, NDA, MAA), development reports, batch records, protocols and associated reports (QbD, Validation).
• Thorough knowledge in the areas of Pharmaceutical Development, Risk Management, Quality Systems and ICH/FDA Guidelines is required.
• Successful history in building and managing formulation and process development functions.
• Demonstrated success managing multiple assignments with timely and accurate output.
• Exceptional written and verbal communication skills.
• Proven problem-solving skills are a must
• Ability to travel up to 25% domestically and internationally.

EOE