What are the responsibilities and job description for the Manufacturing Operations Manager position at Resiliency LLC?
Qualifications
- Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering).
- 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience.
- 5-7 years of leadership experience or equivalent combination of experience.
Responsibilities
- Responsible for the profit and loss for the PPU
- Deliver on revenue
- Assures compliance with budget
- Liaison with support groups – supply chain, training, quality systems, and business development
- Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients
- Sets team expectations and goals and delivers the business direction for the PPU
- Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly.
- Coordinates with PPU leadership and team meetings and determines PPU strategy development
- Accountable for driving the spirit of continuous improvement
- Collaborates with Business Development to ensure compliance and contract requirements
- Meet client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contract
- Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract.
- Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract.
- Ensures process hours are charged - tracked to meet contract and revenue targets
- Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects.
- Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations
- Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff.
- Ensures a safe work environment for employees
- Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice
- Approves job specific curriculum for the training and professional development of department staff.
- Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion.
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