PYRAMID Laboratories, Inc. is a rapidly growing contract manufacturing organization that provides Aseptic Manufacturing and Analytical Services for Sterile Injectable Drugs with expertise in formulation and process development, aseptic filling for vials and syringes, and lyophilization applications.
PYRAMID has established a reputation of exceptional performance, integrity, and quality.
PYRAMID Laboratories, Inc. is in Southern California, United States. The combination of our manufacturing facilities and state-of-the-art laboratory allows PYRAMID to offer the pharmaceutical and biotech industry both analytical and manufacturing support capabilities. An intensive in-house Quality Assurance and Quality Control program is maintained to ensure clients receive high quality products.
POSITION TITLE: Aseptic Manufacturing Manager
SUPERVISES/DIRECTS: Aseptic Manufacturing Supervisor & Technicians
REPORT TO: Director of Aseptic Manufacturing
Under general supervision, perform various aseptic manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques, procedures, and criteria in both aseptic and non-aseptic processing areas. 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 aseptic manufacturing operations including support systems, as applicable.
- Ability to set-up, maintain and perform various aseptic 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 aseptic manufacturing areas, as applicable.
- Author SOPs and production batch records for all aseptic 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 aseptic manufacturing activities according to the applicable guidelines, i.e., GMP, ICH, etc.
- Perform various aseptic 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 aseptic manufacturing operations.
- Ability to initiate problem-solving and technical decision-making commensurate with level of experience.
- Ability to perform technical evaluation of aseptic 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 aseptic 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 aseptic manufacturing related equipment and systems.
- Performs other related duties and responsibilities as assigned.
• Bachelors in Life Sciences, Engineering, Chemistry, Business, or other related fields with a minimum of 10 years industry experience in a cGMP commercial aseptic manufacturing environment in a supervisor or Lead role.
• Prior experience in a cGMP related industry is required, within the sterile Biopharmaceutical industry a must.
• Demonstrates strong knowledge of Good manufacturing Practices (GMP) and ability to apply knowledge of current Good manufacturing Practices (cGMP) on a daily basis.
• Working knowledge of sterile manufacturing facilities, lyophilization technology and aseptic 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 firstname.lastname@example.org .