The GMP Production Manager is responsible for leading multiple production teams, developing staff, fostering a culture of safety and quality, and participating in the daily manufacture and line oversight of GMP custom oligonucleotide products. The manager is responsible for ensuring that production processes are adequately developed, documented and performed in compliance with company procedures and external regulatory requirements. This role is responsible for supporting and scheduling the manufacturing activities of shift supervisors and/or team leads across multiple manufacturing shifts as well as successfully coordinating with planning and lab support teams to ensure that product lead times are consistently exceeded or achieved. It is critical that this manager excel in initiating and fostering a spirit of cooperation within and between departments to achieve high performance working teams.
Areas of Responsibility:
- To perform this job successfully, an individual must be able to perform each essential function satisfactorily.
- Oversee workflow and manage production supervisors and team leads, ensuring company policies/procedures are followed
- Train and verify training of team members
- Ensure manufacturing priorities are completed by:
- § Properly scheduling and assigning personnel
- § Communicating expectations and priorities to team members
- § Managing employee schedules and ensuring adequate staffing levels across shifts and in response to business needs
- § Facilitating corrections to inadequate or out of date processes
- § Facilitating the scheduling of maintenance activities
- § Ensuring adequate equipment is available for production requirements
- Effectively communicate and coordinate with internal suppliers, production support teams and production managers to ensure the most efficient use of time and resources; initiating and fostering a spirit of cooperation within and between departments
- Effectively communicate with maintenance staff to ensure production equipment is functional and available for production.
- Review processes and ensure appropriate work instructions are in place as well as write and review manufacturing procedures and documents as needed
- Provide effective leadership through:
- § Communicating job expectations and expectations of the manufacturing line
- § Initiating, coordinating, and enforcing systems, policies, and procedures
- § Performance evaluations and goal setting
- § Active coaching and mentoring of team members; developing personal growth opportunities
- § Supplying technical expertise to team members
- § Enforce company policy and work with management and HR to address individual performance issues.
- Facilitate corrections to malfunctions within the manufacturing processes through initiation of Deviation and Non-conformance reports and/or support tickets, as needed
- Participate in Quality review boards and support CAPA management
- Proactively interface with production group and internal customers to identify and implement areas of continuous improvement
- Execute on objectives and goals to support a positive, efficient and motivated team
- Manage recruiting and selection of team members
- Oversee and verify training activities for all members of the team
- Ensure adherence to EH&S programs, monitoring and the safe use of hazardous chemicals by all staff in the manufacturing lab spaces
- Supply regular feedback to leadership on achievement of KPI, performance of the team, instrumentation and process
- Provide technical expertise and leadership to team members
- Communicate effectively and with integrity to work cross-functionally across teams to constructively resolve operations issues that impact manufacturing efficiency and quality
Other Skills, Abilities, and Competencies:
- Professional presence and strong attention to detail
- Proven leadership skills with ability to build trust and grow teams
- Technical proficiency that enables effective oversight of the production process
- Effective communication and problem solving abilities
- Demonstrated command of Manufacturing MES systems
- Requires a bachelor’s degree, a minimum of 5-7 years of demonstrated management experience in a related field, including previous experience building leaders of teams, and/or demonstration of ability to meet the requirements of a GMP Manufacturing Manager.
- Microsoft Office, Outlook, Word, and Excel. Use of a web browser.