What are the responsibilities and job description for the Drug Product Production Manager position at Porton Pharma Solutions Ltd.?
Job Title: Drug Product Production Manager
Department: Drug Product Development
Location: Onsite, Cranbury NJ
Job Type: Full Time
Position Reports to: VP of Drug Product Development
Job Summary:
We are seeking a highly motivated and skilled Drug Product Production Manager to join our Drug Product Department at Porton J-STAR. In this role, this position is responsible for overseeing the drug product GMP manufacturing activities in the Drug Product Development group and ensuring smooth technology transfer of R&D processes into the GMP manufacturing suites. The responsibilities include, but are not necessarily limited to, the items listed below.
Responsibilities
- Establish GMP drug product manufacturing system, including but not limited to qualify the facility, procure and perform IQ/OQ of equipment, establish appropriate procedures for maintaining high standards.
- Support drug product development R&D system, including but not limited to procurement of equipment and establishing appropriate procedures.
- Manage the manufacturing activities to ensure that all products conform to established customer and company quality standards.
- Ensure all GMP planning, manufacturing, cleaning, and storage operations run efficiently.
- Author/review/approve protocols, updates, development reports, BMRs, SOPs, CMC regulatory documents & other quality documentation according to regulatory guidelines.
- Work with R&D scientists and drug product GMP manufacturing team to ensure smooth technology transfer of R&D processes into the GMP manufacturing suites.
- Collaborate closely with QC, QA, Maintenance & other groups to ensure timely production & release of clinical trial materials.
- Lead root cause investigations, risk management, deviations, CAPAs as required.
- Identify, recommend, develop, and implement necessary changes, within the appropriate regulatory confines to improve productivity and for continuous process improvements.
- Adhere to EHS policies and maintain work areas in a safe, clean, and orderly fashion.
- Ensure the training program for all levels of manufacturing are current and complete and production personnel are qualified to perform work assigned.
- Ensure a rigorous preventative maintenance schedule is implemented and sustained for all GMP equipment and instrumentation.
Qualifications
- BS, MS or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field, with a focus on drug product manufacturing, preferably within a CDMO or pharmaceutical environment.
- Minimum of 3-7years of hands-on experience in drug product formulation and process development, ideally within a CDMO or pharmaceutical environment.
- Proven experience with GMP manufacturing processes, technology transfer from R&D to GMP manufacturing, and understanding of cGMP regulations.
- Strong leadership skills, with the ability to manage teams and coordinate cross-functional departments to achieve operational goals.
- Ability to lead root cause investigations, manage CAPAs, and implement corrective actions to address manufacturing issues.
- In-depth knowledge of regulatory guidelines, quality systems, and industry best practices.
- Strong communication skills, both written and verbal, with the ability to convey complex scientific concepts clearly.
- Leadership skills with experience mentoring or coaching junior scientists.
- Excellent project management skills, including the ability to prioritize tasks, manage timelines, and meet deadlines.
- Experience in working on and positively contributing to scientific teams.
- Ability to perform the physical requirements of the position.
