August Bioservices, LLC is hiring: Director, Manufacturing in Nashville

Overview

Reporting to the Chief Operating Officer (COO), the Director, Manufacturing oversees all GMP Manufacturing Operations with a focus on aseptic processing in a CDMO environment. The Director will lead sterile manufacturing processes, ensuring day-to-day operational excellence, compliance, and quality within Aseptic Formulation, Filling Operations, Inspection, Packaging, and Serialization.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Lead and manage multidisciplinary teams in aseptic manufacturing, ensuring effective recruitment, coaching, and retention of top talent.
• Communicate departmental goals and performance expectations to staff, providing regular feedback and development opportunities.
• Oversee daily production activities for aseptic formulation, filling, inspection, and packaging operations, maintaining strict quality and safety standards.
• Collaborate with cross-functional teams including Engineering, Quality, Process Development, Validation, Metrology, Materials Management, and Regulatory Affairs on project execution and operational improvement.
• Ensure compliance with relevant global GMP regulations, championing a culture of good manufacturing practices within all manufacturing areas.
• Drive implementation and maintenance of standard operating procedures (SOPs) for all aspects of aseptic manufacturing operations.
• Partner with Project Management to optimize production schedules, facility utilization, and workforce planning to achieve maximum efficiency and throughput.
• Participate as manufacturing subject matter expert (SME) on internal project teams and support client engagement as required.
• Support the evaluation and implementation of new manufacturing technologies and continuous improvement initiatives to enhance productivity, compliance, and product quality.
• Maintain proper staff training and readiness in aseptic manufacturing operations.
• Monitor and proactively address operational risks, ensuring business continuity and meeting customer commitments.
• Manage operating budgets, ensuring effective use of resources for manufacturing activities.

QUALIFICATIONS

• Bachelor’s Degree in Science, Engineering, or related discipline; Master’s preferred.
• 8+ years of experience in pharmaceutical manufacturing within aseptic fill/finish operations, with at least 5 years in a leadership or management capacity in a GMP/CDMO environment.
• Strong experience with Quality Systems and supporting successful regulatory inspections (FDA, EMA, etc.).
• Proven track record in lean manufacturing and continuous improvement initiatives.
• Excellent communication, interpersonal, and cross-functional collaboration skills.
• Demonstrated technical understanding of aseptic processing, commercial-scale production, and GMP compliance.
• Experience writing, reviewing, and implementing SOPs and regulatory documents related to aseptic manufacturing.
• Ability to work effectively both independently and within teams to drive operational excellence.

KNOWLEDGE, SKILLS, & ABILITIES

• Deep working knowledge of aseptic and sterile manufacturing practices.
• Hands-on leadership of teams performing formulation, component preparation, sterilization, filling, lyophilization, terminal sterilization, visual inspection, labeling, cartoning, and serialization.
• Ability to train, mentor, and develop manufacturing staff, fostering a culture of accountability and continuous improvement.
• Experience with technology transfer, scale-up, and supporting regulatory submissions related to manufacturing.
• Commitment to full GMP compliance and application of latest industry best practices.
• Capacity to contribute to construction, qualification, and startup activities for expanded manufacturing spaces.
• Technical depth in aseptic manufacturing processes
• Operational and project management skills
• Leadership and people development
• Strong regulatory and compliance knowledge
• Collaborative and results-driven work style
• Effective communicator across all organizational levels

PHYSICAL REQUIREMENTS

• Prolonged periods sitting at a desk and working on a computer
• Ability to lift up to 50 pounds as required

Seniority level

• Director

Employment type

• Full-time

Job function

• Management and Manufacturing

Industries

• Pharmaceutical Manufacturing