Supervisor/Manager Manufacturing

The Supervisor and Manager role, will play a role in facility start-up and commercialization, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Client's Richmond, VA site. This position will hire, develop, and support a team of manufacturing associates through equipment qualifications, identifying and improving processes, operating manufacturing equipment, and owning documentation.

Essential Duties and Responsibilities:

· Under the Director of Manufacturing’s direction, actively participate in new equipment and process qualifications.

· Demonstrated ability to act as subject matter expert in manufacturing processes, including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).

· Serve as the escalation point for their group, take accountability and ownership for business, technical, and compliance decisions

· Maintain Client's right to operate:

o Maintain inspection readiness and serve as SME during inspection tours

o Ensure staff are appropriately trained and qualified for the activities they perform prior to execution

o Ensure systems and processes are properly executed and maintained to ensure staff’s safety, product quality, and continuity of supply

· Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements.

· Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.

· Responsible for identifying opportunities to improve customer service, quality, safety performance, process efficiencies, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing tools and techniques.

· Mentors, coaches, and teaches Manufacturing Associates in the use of change management/control techniques to ensure timely completion of projects.

· Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of the timely resolution of deviations/discrepancies related to Manufacturing.

· Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify the effectiveness of CAPA by post-project data collection and analysis.

· Demonstrated ability to act as subject matter expert in manufacturing processes, including autoclaves, parts washers, clean-in-place (CIP), and material transfer isolators (MTIs).

· Flex schedule to meet commitments and achieve milestones related to projects, production, and other demands of the role.

· Ability to work on-site is required

· Maintain accuracy of and approve staff’s timecards

Minimum Qualifications (Knowledge, Skills, and Abilities)

· Bachelor's degree with 4 years of demonstrated ability in a cGMP FDA, cGMP, ISO, or other regulated production environment. An associate’s degree and 6 years of cGMP production experience may be considered.

· Experience with Autoclaves and Parts Washers.

· 1 years supervisory experience in a GMP manufacturing environment.

· Experience in a process improvement environment, including change management and leading teams.

· Lean Manufacturing/Six Sigma Green Belt Certification preferred.

· Strong writing and documentation skills.

· Self-directed with effective analytical and problem-solving skills.

· Strong interpersonal, collaboration, communication, and leadership skills.