Director, Drug Substance Development and Manufacturing - REMOTE

Proclinical is seeking a remote Director, Drug Substance Development and Manufacturing for a leading biopharmaceutical company. This position is responsible for the management, coordination, and implementation of cost-effective commercial manufacturing processes in a cGMP compliant environment.

Job Responsibility:

• Responsible for the manufacturing process of small molecule drug substance used to support clinical trials and commercial supplies.
• Support establishment of secondary suppliers for drug substance, including technology transfer, validation and CMC regulatory for drug substance.
• Key member of pharmaceutical operations and will be held responsible for delivering drug substance goals.
• Develop and manage all process operations
• Plan and coordinate external drug substance supply to achieve program goals
• Liaise with cross functional department heads such as Project Management, Supply Chain and Technical Operations to optimize available-to-promise levels, manage product expiry, identify risk and mitigation plans and maintain accurate inventory
• Develop vendor performance evaluations through metrics and provide KPIs to senior management
• Provide technical review of executed production records, protocols, stability data, etc.
• Identify new commercial manufacturing partners and manage technology transfer, scale-up and validation activities to bring secondary suppliers online
• Support activities for new products, including drug substance evaluations (scale-up potential, ADME, etc.)
• Manage internal and external resources needed to support research and commercial production activities
• Manage exempt and/or non-exempt internal positions (if any)
• Ensure all manufacturing processes are cGMP compliant including all supporting documentation for both internal and external sources
• Investigate nonconformities and perform root cause analyses, as necessary
• Prepare documents for regulatory submissions including IND/NDA/MAA and post approval (for both US and ex-US submissions)
• Perform person-in-plant oversight at the manufacturing sites requiring travel both domestically and internationally
• Assure and track all budget and CMO activities against Purchase Order

Skills and Requirements:

• M.S. or Pd.D. degree in organic chemistry or equivalent in a related field (PhD preferred)
• At least 10 years of relevant clinical and commercial pharmaceutical industry experience (8 years if PhD)
• 7-10 years of program/project management experience in pharmaceutical industry
• Small molecule experience with successful NDA /MAA development
• Previous direct supervisory experience
• Demonstrated leadership to drive results that are required to achieve the company's goals
• Excellent communication, project management, and organizational skills
• Ability to develop strong relationships with external vendors and internal stakeholders
• Ability and willingness to travel is required
• Understand drug development and commercialization process
• Proficient in development of clinical tools and documents
• Excellent management and team facilitation skills
• Experience in managing projects
• Exceptional attention to detail and planning and organizational skills
• Knowledge of relevant GMP, GLP and general ICH/FDA/EMEA guidelines

If you are having difficulty in applying or if you have any questions, please contact Sam Jankura at (+1) 617-671-0335 or s.jankura@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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