Porton Pharma Solutions Ltd. · 12 hours ago
Drug Product Production Manager (GMP)
Cranbury, NJ
Full-time
Onsite
Mid, Senior Level
3+ years expPorton Pharma Solutions Ltd. is seeking a highly motivated and skilled Drug Product Production Manager to join their Drug Product Department. This role is responsible for overseeing GMP manufacturing activities and ensuring smooth technology transfer from R&D to GMP processes.
Pharmaceuticals
Hiring Manager
孙于文
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
Qualification
Required
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 3-7 years 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
Company
Porton Pharma Solutions Ltd.
With over 4,200 employees and 18 operations and commercial offices across the US, EU, and China, Porton Pharma Solutions provides global pharmaceutical and biotech companies with innovative, reliable, and end-to-end process R&D and GMP manufacturing services across Small Molecules, Tides, Biologics and Conjugates (ADCs, AOCs, PDCs, RDCs, etc.), as well as Advanced Therapy Medicinal Products.
5001-10000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase