Manufacturing Site Head / Northern California Plant Manager
Reference Job No. 14-09
Pearl’s Manufacturing Site Head will be responsible for starting up and operating Pearl’s new GMP manufacturing facility in Redwood City, California. This facility will manufacture clinical and commercial excipients and micronized API for use in Pearl’s commercial and pipeline products.. The candidate will be responsible for implementation of new processes, technical management of existing processes, and continuous support of manufacturing through commercial and life-cycle management. . The leadership and strategy provided by the candidate will be critical to the assurance of successful manufacturing readiness and successful clinical supply and product launch. The candidate will be responsible for developing the manufacturing organization The position requires management of staff on shifts building up to 24 × 7 operations; including creating and managing the Quality Control, Site Operations, and Technical Services groups. Success is measured by production of high quality bulk drug substance and excipients with efficient and effective use of resources, minimization of deviations, a well-managed staff, and effective collaborations with supporting departments. In addition the effective transition to and establishment of multiproduct commercial operations and transfers of operations to other sites are high priority measures of success.
The candidate for this position will interact closely with process development, supply chain, and the quality organization in order to ensure product supply, and continuous improvement of our supply chain in non-clinical and clinical manufacturing. Therefore, demonstrated ability to influence and collaborate across a global matrix organization is desired.
Redwood City, CA
- Oversee all manufacturing operations to meet forecasted demand while maintaining a high level of GMP compliance and being cost efficient.
- Develop and continually update the production schedule on a weekly monthly and quarterly basis and ensure alignment/adjustment of manufacturing schedule to meet to corporate goals and metrics, as required. This includes continuous communication with Quality and Technical Groups to ensure efficient management of Pearl’s commercial and clinical manufacturing activities.
- Ensure that equipment and processes are appropriately maintained, validated and approved for specified manufacturing activities.
- Ensure appropriate training of all manufacturing personnel on equipment, processes and facility procedures as well as safety is maintained and up to date.
- Ensure compliance with occupational safety, health, environmental, and other regulatory standards
- Manufacture to a high, and continuously improving, level of GMP compliance to ensure patient safety and to minimize risk to the company business. Support manufacturing investigations, regulatory licensing activities, and agency and downstream client inspections. Provide expertise and leadership in formulating inspection responses.
- Motivate, recruit and develop key employees. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
- Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error. Support strategic plans for process and plant improvements in order to increase efficiency and drive down costs.
- Communicate operational status regularly to senior management.
- Effectively plan and manage the budget required to operate the facility. Support implementation of capital projects within budgets and timelines.
- Candidate should have a degree in chemistry, industrial pharmacy, or engineering. Advanced degree is preferable.
- 10+ years of supervisory and/or manufacturing management experience in pharmaceutical operations.
- Understanding of pharmaceutical facility design and engineering.
- Experience with or knowledge of one or more of the following, as appropriate: spray drying, micronization, separation sciences, process engineering.
- Strong leadership skills and substantial experience with manufacturing of pharmaceutical APIs or excipients, with experience in NDA approvals, regulatory inspections and technology transfer is preferred.
- Understanding of regulatory requirements in drug product and drug product manufacturing including IND and NDA submissions, process validation preferred.
- Industry experience with providing technical support of approved commercial excipients or APIs or finished products is strongly preferred.
- Understanding of worldwide cGMP and process requirements in early, late-stage and commercial manufacturing is preferred.
- Excellent verbal and written communication skills, detail-oriented personality, and ability to work productively in an interdisciplinary team environment.
- Demonstrated experience developing employees and cultivating high performance teams
- Commitment to operational excellence.
Pearl is an equal opportunity employer. We celebrate and seek to build upon the diversity of backgrounds reflected by our highly motivated, talented, and productive team.
Pearl offers its full time employees a competitive set of medical and other benefits.
Qualified applicants please submit your resume to Pearlofajob@PearlTherapeutics.com and include the job reference number listed on the job description.
Principals only, please.