Mid-level industry position
- 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 firstname.lastname@example.org .