Associate Director, Manufacturing Operations

The Associate Director, Manufacturing Operations is responsible for leading GMP
manufacturing operations while developing and sustaining a highly capable, compliant, and
production-ready workforce. This role integrates strategic operational leadership with end-to-end
ownership of manufacturing programs, ensuring alignment with GMP, aseptic processing, and
regulatory expectations.

This leader oversees daily manufacturing execution, material readiness, and production support
activities while designing and driving robust training strategies that ensure continuous
operational readiness. The role serves as a key business partner to Manufacturing, Quality, and
cross-functional teams to enable safe, compliant, and efficient production while fostering a
culture of quality, accountability, and continuous improvement.

Essential Duties & Responsibilities:
· Provide leadership for GMP manufacturing operations, ensuring safety, quality, and production
targets are consistently achieved while driving right-first-time execution.
· Oversee material readiness, batch preparation, labeling verification, and production
coordination to support uninterrupted manufacturing operations.
· Own audit readiness of cleanrooms and minimize equipment downtime for schedule adherence
of manufacturing activities
· Own and lead the manufacturing training strategy, including onboarding, OJT programs,
aseptic qualifications, and continuous workforce development.
· Partner with Quality to lead deviation investigations, CAPAs, and change controls, ensuring
strong documentation practices and sustained audit readiness.
· Oversee aseptic and controlled environment operations, ensuring all personnel are properly
trained, qualified, and compliant with GMP standards.
· Drive continuous improvement initiatives across operations and training by identifying gaps,
optimizing processes, and enhancing efficiency and compliance.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed,
color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status,military
status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Education/Training:
· Bachelor’s degree in Life Sciences, Engineering, Operations Management, or related field
required; Master’s degree preferred
Experience:
· 7+ years of direct manufacturing experience in GMP-regulated pharmaceutical, biotech, or cell
therapy manufacturing
· 5+ years of managerial experience directly managing people and leadership experience leading
teams.
· 5+ years of GMP training program development, instructional design, and LMS management
· Demonstrated leadership experience in manufacturing operations, training, or both
· Experience with batch records, deviation management, CAPA, and working in
controlled/aseptic environments

Experience:
· Minimum 5 years of direct, hands-on manufacturing experience in a GMP-regulated
environment, including managerial responsibilities and proven leadership in operational settings.
· 5+ years of experience developing GMP training programs, instructional design, and managing
learning management systems, preferably with a background in manufacturing operations.

Knowledge:
· Strong knowledge of cGMP, GDP, and global regulatory requirements (FDA, EMA)
· Expertise in aseptic processing and manufacturing compliance standards
· Familiarity with ERP/MES/eQMS systems (e.g., SAP)

Skills:
· Strong leadership, coaching, and team development capabilities
· Expertise in training program development, instructional design, and management
· Excellent technical writing skills (SOPs, deviations, training materials)
· Strong problem-solving, communication, and cross-functional collaboration skills
Certifications/Licenses:
· None required; relevant GMP or instructional design certifications preferred