The Supervisor, Manufacturing, oversees the manufacturing process and the department personnel on designated shift to ensure process meets cGMP (current Good Manufacturing Practices) and company standards for an aseptic operation. Trains and develops department technicians.

ESSENTIAL DUTIES & RESPONSIBILITIES may include the following. Other duties may be assigned.

Provides immediate supervision to a unit or group of employees, assigning tasks, checking work at frequent intervals, and maintaining schedules.

Oversee production review of all department batch documentation for completeness and accuracy.

Initiate Facility Work Orders when equipment requires repair.

Participate in process/product troubleshooting in order to correct/maintain aseptic processing and desirable product yields, as well as environmental control of facility.

Recommend and implement measures to improve production methods, equipment performance, facility layout, and quality of product.

Maintain a quality presence to ensure compliance with all regulatory requirements.

Maintain current knowledge of regulatory and industry standards.

Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.

Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.

Provide guidance and hands-on training to direct reports.

Appraise and monitor performance of department personnel.

Coach, counsel, address complaints and resolve employee related issues with the collaboration of Human Resources.

Provide a leadership role ensuring employee health and safety.

Involved in interviewing/selection process of hiring or promoting department personnel.

REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

• Associate’s degree required. Bachelor's degree preferred. Emphasis in Biology, Chemistry, Chemical Engineering or closely related scientific / technical discipline is preferred.
• Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required.
• Equivalency: In lieu of an Associate's degree, candidate must have a High school diploma or GED, and a minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA regulated environment.
• Requires an in depth understanding of pharmaceutical manufacturing operations, including protein purification and aseptic processing.
• Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
• Prior supervisory or leadership experience is highly preferred.
• Demonstrated ability to inspire high performance in others and align team members around shared goals.
• Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
• Demonstrated project management skills.
• Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
• Must be proactive, results oriented, and have strong attention to detail.
• Self-starter with strong work ethic and the ability to exercise good judgment.
• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
• Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
• Excellent verbal and written communication skills in the English language.
• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Must be flexible with working hours / shifts in order to accommodate the 24-hour, 7-day plant operation.

Occupational Demands Form Work is performed in an office and/or a laboratory/manufacturing environment or plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

*This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.