August Bioservices
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr