This position is a key member of the team and as such is involved in executing the Company’s long- term mission and short- term goals and objectives as it relates to operations.
This position plays a critical role in the success of the company with responsibility for leading the technology transfer, process validation, and ongoing manufacturing of a critical drug component. This work will occur in our newly launched manufacturing facility in Gaithersburg, MD. This drug component will be used in the manufacturing of our commercial-stage proprietary product, a revolutionary drug-eluting biomatrix used in pacemaker procedures.
This position will have ongoing responsibility for leading and optimizing critical aspects of operations, ensuring that the Company’s product offerings are manufactured with the highest standards of quality while lowering operational costs and ensuring consistent product supply.
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Tech Transfer:
- Collaborate with current supplier to obtain documentation and know-how on current manufacturing process
- Design and lead the build-out and validation of the company’s drug component manufacturing facility, to meet GMP requirements
- Collaborate with external vendors for incoming material testing, equipment sourcing, raw material sourcing, lot release testing, etc.
Process Validation and Optimization:
- Develop the Master Validation Plan
- Lead the process validation, including writing all necessary reports, to ensure processes consistently meet intended specifications and requirements
- Coordinate and execute validation studies (IQ, OQ, PQ) including writing protocols, analyzing results and generating a final validation report. Validation activities include equipment qualification, packaging qualification, process validation, cleaning/sterilization validation and computer related systems (i.e. batch record) validation.
- Develop all required process documentation, including SOPs, work instructions, batch records, BOMs, etc. Collaborate with our Quality team to ensure all key quality requirements are met and the quality system is comprehensive and robus
- Identify, prioritize and evaluate current and future process improvement opportunities to increase scale, reduce COGS and improve quality
- Collaborate with our R&D team to support regulatory filings associated with manufacturing changes
Manufacturing Launch and Ongoing Operations:
- Transfer production process from validation to a fully operational commercial production
- Support the hiring, training and management of the facility’s Operations and Quality team
- Scale production to meet commercial needs
- Lead day-to-day manufacturing operations with a hands-on approach, guiding by example.
- Work with outside vendors and suppliers to ensure high quality, timely services are provided.
- Lead production planning including resource optimization, inventory management, data analysis, equipment maintenance, budgeting, and forecasting
- Develop, validate, and execute test methods focused on incoming materials and lot release tests to reduce reliance on external vendors
- Identify and lead operational improvement activities, including cost evaluation with the goal of decreasing COGS for all product offerings
- Ensure compliance with all applicable regulations and standards
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