Job description
Mantell Associates is partnered with a science-driven CDMO who are searching for an Aseptic Manufacturing Supervisor. You will be responsible for supporting the overall GMP Fill Finish manufacturing processes through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for Phase I/II & commercial GMP manufacturing.
Aseptic Manufacturing Supervisor - Responsibilities:
Lead a team of manufacturing technicians
Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs and safety regulations
Performs training with staff on the floor, as needed
Point person on shift to assign/distribute the work and coordinate emergency situations
Performs training with staff on the floor, as needed
Maintain aseptic qualification training
Support and demonstrate skill set to Manufacturing Technicians I, II, and III
Ensure documentation (batch records and SOPs) are accurate and updated as required
This role is responsible for the accurate, safe, environmentally responsible, and quality-compliant operations of the manufacturing process
Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improvement
Recommends equipment and supply purchases within the production areas
Exhibit safety leadership by example (e.g., utilize proper PPE when performing job functions)
Responsible for shift schedule and summarizing shift progress at the end of the shift
Lead and mentor staff. Write performance reviews and annual goals and hold one-on-ones
Effectively communicate results of departmental work through team discussions and documentation
Ensure cGMP compliance and all its related elements in documentation, reports, and records
Initiate non-conformances when identified and complete investigations to support on-time closure of deviation
Understand and review current regulations, industry guidance, and other applicable professional documentation
Additional duties, as assigned
Aseptic Manufacturing Supervisor - Requirements:
B.S. in Engineering or Science discipline and a minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations, related technical field, or equivalent industry experience. (Some or all this experience should be in fill/finish processing), or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities
Experience with GMP fill finish operations and sound understanding of the drug development process
Aseptic Filling or Pharmaceutical Manufacturing experience: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices
Has considerable knowledge/expertise relevant to fundamental Fill/Finish manufacturing operations
Has sound understanding and knowledge of all fill finish operations, including aseptic hand filling and automated filling of liquid vials
Demonstrated track record of leading or supervising hands-on cGMP manufacturing operations
Demonstrate skill/experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC, MC, and other manufacturing groups) to maintain internal and project schedules
Demonstrated ability to motivate and mentor peers, staff, and foster a culture of continuous improvement and operational excellence
Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates
Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision
Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required
Must be able to comprehend and follow all applicable SOPs
Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise
Demonstrated knowledge of current federal, local, and international regulations regarding the production, testing, and release of drug substances and products
Demonstrated thorough understanding of cGMPs, industry, and regulatory standards and guidelines
Demonstrate experience with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
Demonstrated ability to execute a task, unit operation, and/or document (forms and/or SOPs) with little to no assistance
Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment
Creative and open-minded who fosters an environment in which sharing of ideas is encouraged
Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally)
Demonstrate the ability to work well in a cross-functional team environment
Must communicate fluently in English and have legible handwriting
Physical Demands:
Ability to travel between and within facilities to visit staff, operations, and projects, as needed
Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary)
Ability to lift up to 40 pounds on occasion
Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary)
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.