The Senior Manager of Pharmaceutical Manufacturing will be responsible for managing the drug substance and drug product manufacturing activities of the Company, which are principally carried out through the use of contract manufacturing organizations and contract laboratories. He/she will work with the Company's Quality Group to ensure that assigned manufacturing activities are conducted in compliance with Good Manufacturing Practices, while ensuring that drug product is available on time and on budget.
RESPONSIBILITIES:
The Senior Manager of Pharmaceutical Manufacturing will direct and maintain all facets of contract manufacturing and supply chain operations relating to the production, packaging, and distribution of pharmaceuticals for international clinical studies. This person will also oversee development and implementation of manufacture and supply chain systems for future commercial products.
• Hands-on management of drug substance and drug product manufacturing including direct oversight of vendor selection, vendor management, materials management, batch record preparation and review, attendance at all manufacturing campaigns, as well as planning/oversight of scale up and tech transfer activities.
• Working independently and with internal groups, co-development partners and external suppliers to develop and/or review component and raw material specifications, product specifications, processes and procedures, formulations, analytical methods, stability programs, release testing procedures, scale-up processes, SOPs, validations and other controls for the company's products, as appropriate for such products stage of development.
• Ensuring that drug substances and drug products are of the quality required for their intended use and stage of development, incorporating internal quality standards, as well as cGMP and other drug regulatory requirements.
• Prepare, review and approve manufacturing, packaging and stability study documentation and reports for CMC sections of all regulatory filings.
• Working with the Quality Group to investigate and document deviations in a timely manner, as appropriate.
• Actively analyze and develop action plans to address CMC issues as required to fulfill corporate objectives.
• Working with the finance, project management and clinical departments to determine the appropriate amount and timing of delivery of clinical trial supplies.
• Act as a technical expert with regard to new product development, validation, technology transfer, technical support and troubleshooting.
• Provide strategies for production of pharmaceuticals for global development and commercialization.
• Participate in assessment of potential technology acquisitions from a CMC perspective.
• Maintain current professional knowledge base of manufacturing, process and formulation development, analytical sciences and regulatory requirements.
REQUIREMENTS:
• MS or Ph.D. in chemistry or chemical engineering.
• A proven record of achievement with at least 5 years experience in the development of pharmaceutical products including preparation of chemistry, manufacturing and controls (CMC) documentation and FDA interactions.
• Experience in manufacturing both drug substances and drug products required, either in-house or through third party CMOs.
• Experience sourcing and negotiating supply and quality agreements with, and successfully managing, contract manufacturers and analytical labs.
• Experience in project management and technology transfers of CMC processes in pharmaceutical arena.
• Comprehensive understanding of cGMP (FDA and ICH) requirements and ability to effectively interpret and efficiently apply them.
• Hands on, energetic and results-oriented.
• Strong negotiation, presentation and written and verbal communication skills.
• Excellent organizational and contract administration skills.
• Dedication to quality and reliability in all work tasks.
• Ability to work cross-functionally with all levels of management.
• Ability to work independently and in a team environment.
• Ability to travel as necessary, consistent with project needs.
