About this role
Overview: Primarily responsible for ensuring CMO drug product manufacturing facilities meet product requirements as per business plan. Also coordinates drug product materials planning, control, inventory management, and GMP shipping functions.
Principle Responsibilities and Duties: Note: The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:
Drug Product Manufacturing
Responsible for ensuring CMO drug product manufacturing facilities meet product requirements as per business plan.
Provide technical expertise and consultation for CMO.
Work with the CMO to ensure vial and syringe fill activities are executed aseptically and per process development procedures.
Work with the CMO to ensure lyophilized product formulation and cycle development are employed as appropriate
Work with CMO to perform process monitoring, trending and improvement for commercial drug products
Quality and Compliance
Ensure critical corporate standards are met in both quality and compliance with cGMP standards
Ensure compliance with federal (FDA, DEA, EPA, OSHA), state and local regulations and adherence to all company policies and procedures relating to Good Manufacturing Practices, EH&S practices, etc.
Inventory Control
Maintain raw material policies, procedures and risk mitigation strategies with CMOs.
Track the placement of replenishment orders with suppliers and monitors delivery and release schedules for drug product manufacturing.
Responsible for coordination with CMO for the storage and shipment of inventory.
Travel as required to manufacturing sites located throughout the world
Person-in-plant during production runs
Coordinate and attend kick-off meetings with drug product CMOs
BS is required.
Minimum of 5 years’ drug product experience in the biopharmaceutical / pharmaceutical industries – biopharmaceutical experience preferred.
Must have knowledge of applicable Quality and Regulatory guidelines.
Must have experience with guiding GMP investigations at CMOs.
Must work well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior management.
Prior experience managing third party CMO relationships and as person in plant during manufacturing runs.
Must have strong negotiating and interpersonal skills, and the ability to clearly present recommendations.
Excellent decision-making, leadership, interpersonal, written and verbal communication skills.
Must have strong computer skills, including all MS Office applications.
Experience with device development controls including Device History Files (DHFs) and Product Requirement Specifications desirable but not required.
Travel
Ability to travel domestically and internationally, up to 25% and for short-term assignments (3 months) up to 50%.
Our Company offers excellent benefits including medical, dental, vision, life, short and long term disability plans, 401k, FSA, vacations, paid holidays and health club reimbursement.