SUMMARY

The role is responsible for leading and developing a shift of hourly operations staff, creating a culture of safety and compliance, maintaining training objectives, and collaborating with peers. The Supervisor is accountable for plant activities, monitoring processing, maintenance of production equipment and facilities in the manufacturing areas, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices. The position may require occasional "off hours" and holiday support as required.

RESPONSIBILITIES

The shift schedule for this position is Day Shift: Wednesday-Saturday, 7am – 6pm.

The Manufacturing Supervisor is responsible for one of the teams/shifts within the Gene Therapy Upstream Department; ensuring safety and compliance with cGMPs are maintained at all times. Ensures the efficiency of material, processing requirements, equipment function and personnel performance for day-to-day operations. As a leader of a shift, provides tactical and supervisory leadership so that mission, vision, and department objectives are met.

Processing:

• Responsible for daily operations on the production floor, including scheduling, staffing, training, material use and troubleshooting to ensure that all operations are in full compliance and safety guidelines.
• High level of understanding and experience with Upstream and Buffer processes, automation controls, compliance and theory.
• Technical proficiency in area of responsibility and ability to provide technical instruction and training processes to staff and team
• Troubleshoot, identify issues and support resolution with support groups
• Ability to perform operational tasks in respective work area

People:

• Responsible for interviewing, selecting and training staff to maintain workforce
• Provides effective leadership through:
  • Assessing and managing performance of direct reports, team and self
  • Individual goal setting and performance reviews
  • Manage performance issues, development and enforcing policies
  • Ensure the use of safe and compliant work practices and behaviors

Quality:

• Issue deviations and change requests and work with depart manager and/or QA professional to evaluate CAPA, assist with closure and implement actions
• Provide technical expertise to resolve manufacturing issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs
• Core quality commitments (logbook and BR review, maintain training compliance, assist with revision of procedures and batch records)
• Ensure staffing levels and skill sets are maintained and training is in compliance

Strategic Influence:

• Oversee floor staff and process operations, identify and coordinate repairs, identify and assist with deviations, review batch records, author change requests for improvements.
• Recommends actions and regularly exercises discretion in regard to processes within work area
• Uses data analysis tools and methodologies and applies judgment to solve systematic problems

Contribution:

• Accountable for operations and results on an assigned shift
• Applies broad processing knowledge and experience to complete work and develop team
• Executes on objectives and goals to support a positive, efficient and motivated team

Leadership:

• Plans and oversees the daily activities of a work team
• Assigns tasks appropriately to ensure accurate completion is achieved
• Provides training,  guidance and development to others
• Spends a portion of time performing the work with the team
• Manages a team of processing associates

EDUCATION

• B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.

PREFERRED EXPERIENCE AND QUALIFICATIONS

• 6+ years of directly related industry experience, including at least 2+ years with proven leadership role
• Technical expertise in large scale processing with various complex cell culture platforms
• Experience with cGMP's in a biologics manufacturing facility
• Ability to independently manage work, actions and expectations is essential
• Strong organizational, collaborating and communication skills