Manufacturing Manager
Title: Manager, Manufacturing Operations
Location: Exton, Pennsylvania
Reports to: Vice President, PD & Manufacturing
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed.
Roles & Responsibilities:
- Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing.
- Manage a team of manufacturing technologists, operators, and warehouse coordinators.
- Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing
- Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution.
- Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required.
- Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs.
- Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM.
- Write, review and approve SOP’s, qualification protocols, and other GMP documentation.
- Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients.
- Implements site initiatives in production operation as advised by site management.
- Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications.
- Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports.
- Responsible for compliance monitoring of area operations.
- Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues.
- Process and analyze manufacturing results, data and provide status updates to the management.
- Establish and maintain positive relationships with project stakeholders.
Education, Experience & Skills Required:
- Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry.
- Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing.
- 5+ years of people management experience.
- Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
- Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable.
- Ability to perform frequent physical tasks with strength and mobility.
- Experience in microbiology and sterile manufacturing is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- Bachelor's Degree in Pharmaceuticals, Engineering or Sciences
- 8+ years in the pharmaceutical industry
- Strong experience in tech transfer and process development
- 5+ years of people management experience
- Experience with cGMP guidelines and regulations
- Strong knowledge of FDA, EMEA & ISO regulations
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
