Supervisor, Manufacturing - United States
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- Our Romany 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.
- Our company leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- Our company will continue to focus on advancing therapies that are the first or best of their kind and make a big difference in improving patients' lives.
- The Supervisor of Manufacturing is responsible for leading a department of supervisors and operations staff, developing staff capabilities, creating a culture of safety, maintaining training objectives, compliance and collaboration while implementing process improvements where applicable.
- 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 shift work; potentially including weekends, off hours, and holidays.
As a leader of a Mfg 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 all operations are in full compliance with regulatory and safety guidelines
- Demonstrate a high level of understanding and experience with cell culture technologies, automation controls, and compliance
- Demonstrate technical proficiency in area of responsibility and ability to provide technical instruction and training processes to staff and team
- Troubleshoot and identify issues while supporting resolution with outside 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 department Manager and/or QA professionals to evaluate corrective actions (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
- Ensure production and processes comply with cGMPs
- Perform 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.
- Recommend actions and exercise discretion in regard to processes within work area
- Uses data analysis tools and methodologies and apply sound 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.
- 6+ years of directly related industry experience, including at least 2+ years with proven leadership role
- Ability to independently manage work, actions and expectations is essential
- Demonstrated technical expertise in large scale processing with various complex cell culture platforms
- Experience with process development, process transfer, validation and multi-product operations
- Strong organizational, collaborating and communication skills
- May have in excess of 5 direct reports to supervise