Supervisor, Manufacturing (Cell Culture) - United States
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company ’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- This position is a great opportunity to join a talented and energetic manufacturing team that has seen a lot of growth and opportunity over the last few years.
- 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.
- The Manufacturing Supervisor is responsible for a discrete shift (5-7 employees) within the cell culture group; 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.
- 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 cell culture technologies, 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
- 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
- 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
- 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
- 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
- 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
- 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