POSITION TITLE: Aseptic Manufacturing Manager
REPORT TO: Director of Manufacturing
Manufacturing Supervisor & Technicians
Under general supervision, perform various manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques, procedures and criteria. Able to summarize findings and prepare or assist in the preparation of reports, documents, records, etc., for assigned tasks. Other responsibilities include monitoring, troubleshooting, maintaining and validation of equipment required for related manufacturing operations including support systems, as applicable.
- Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation.
- Ensure that appropriate procedures and processes are utilized without unauthorized modifications.
- Train and supervise all subordinate employees within manufacturing areas, as applicable.
- Author SOPs for all manufacturing related activities as required for a GMP compliant Fill/Finish operation.
- Review all specifications, criteria, etc., and ensure all specified materials, equipment, and processes meet the required guidelines and/or industry standards.
- Perform all duties and manufacturing activities according to the applicable guidelines, i.e. GMP, ICH, etc.
- Perform various manufacturing duties and initiate appropriate documentation as required including all forms, logs, batch record, etc. according to applicable SOPs.
- Familiarity with computers and software programs utilized for the generation of data and associated reports as related to manufacturing operations.
- Ability to initiate problem-solving and technical decision-making commensurate with level of experience.
- Ability to perform technical evaluation of manufacturing related information and provide management with status reports including information required for decision-making purposes.
- Ability to calibrate, maintain and trouble-shoot various equipment as required for the manufacturing operations.
- Perform validation protocols for specific projects in compliance with IQ/OQ/PQ requirements and industry guidelines.
- Develop written preventive maintenance programs for all manufacturing related equipment and systems.
- Performs other related duties and responsibilities as assigned.
- BS in Life Sciences, Engineering, Chemistry, Business or other related fields with a minimum of 10 years industry experience in a cGMP pharmaceutical or medical device commercial manufacturing environment in a Supervisor or Lead role.
- Prior experience in a cGMP related industry is required, within Biopharmaceutical or Pharmaceutical industry preferred.
- Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and ability to apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis.
- Working knowledge of pharmaceutical/medical facilities, lyophilization technology and manufacturing equipment. Proven aseptic process experience.
- Strong troubleshooting and root cause analysis skills are a plus.
- Excellent leadership, communication, planning, and organization skills.
- Able to effectively lead and coordinate multiple, complex requests/projects and allocate resources effectively.
- Strong commitment to operational excellence, safety and quality with a positive working attitude.
- Demonstrates strong computer, organizational, and project management skills.
- Demonstrates ability to recognize deviation from accepted practice.
- Must have excellent written, verbal, and presentation skills with a demonstration ability to work effectively in a fast-paced environment. Must be able to communicate clearly, effectively, and concisely with subordinates, peers and management.
To apply for this position, please email your resume with cover letter to email@example.com .