- 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.
- 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.
-
Manufacturing Manager
3 weeks ago
Trinity Consultants Engineering & EHS Workforce Solutions Exton, United StatesThe Manufacturing Manager assures that Biomedical products are of consistent and high quality by managing operations in compliance with Safety, Health & Environment (EHS) standards and quality system requirements to meet customer quality and service expectations. This role will h ...
-
Manufacturing Manager
4 weeks ago
ACS Global Search Inc West Chester, United StatesJob Description · Job Description · ACS has been exclusively engaged to locate an experienced Job Title Manufacturing Manager · Reports to: Vice President/General Manager · Objective · Is responsible for the management of all the activities in the Production and Shipping/Rece ...
-
Manufacturing Manager
3 weeks ago
ACS Global Search West Chester, United StatesJob Description · Job DescriptionACS has been exclusively engaged to locate an experienced Job Title Manufacturing Manager · Reports to: Vice President/General Manager · Objective · Is responsible for the management of all the activities in the Production and Shipping/Receiving · ...
-
Manufacturing Manager
4 weeks ago
dsm-firmenich Exton, United StatesManufacturing Manager · Location: Exton, PA · Place of Work: On-site · The Manufacturing Manager assures that dsm-firmenich Biomedical products are of consistent and high quality by managing operations in compliance with Safety, Health & Environment (SHE) standards and quality ...
-
Manager Manufacturing
4 days ago
Frontage Laboratories Exton, PA, United StatesManufacturing ManagerTitle: Manager, Manufacturing OperationsLocation: Exton, PennsylvaniaReports to: Vice President, PD & ManufacturingFull-timeFrontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over ...
-
Manufacturing Manager
3 weeks ago
Trinity Consultants Engineering & EHS Workforce Solutions Exton, United StatesThe Manufacturing Manager assures that Biomedical products are of consistent and high quality by managing operations in compliance with Safety, Health & Environment (EHS) standards and quality system requirements to meet customer quality and service expectations. This role will h ...
-
Automotive Manufacturing Program Manager
2 weeks ago
Tenneco Exton, United StatesAutomotive Manufacturing Program Manager (PMO) · Responsible for the implementation and coordination of new products and processes from US Technology and Product Development into Manufacturing · Must be able to work with Sales Management, Marketing, Manufacturing and Quality to e ...
-
Manufacturing Manager
3 weeks ago
Avo Photonics Horsham, United StatesAvo Photonics () is a dynamic contract engineering services company that designs, develops and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to design, prototype, and produce next generation products for a divers ...
-
Manufacturing Manager
1 week ago
CapstoneONE Search Reading, United StatesA rapidly growing, multi-billion-dollar aerospace component manufacturer seeks to hire an Area Manufacturing Leader (Manager) at their flagship production campus in Eastern Pennsylvania due to their continued growth. This critical position will direct operations for one of the la ...
-
Manufacturing Engineering Manager, NPI
1 week ago
dsm-firmenich Exton, United StatesManufacturing Engineering Manager, NPI · Exton, PA (on-site) · The Manufacturing Engineering Manager will provide purpose, direction, and motivation while operating to accomplish the goals and improving the Manufacturing Engineering Group. They will provide guidance and expertise ...
-
Manufacturing Engineering Manager, NPI
2 weeks ago
dsm-firmenich Exton, United StatesManufacturing Engineering Manager, NPI · Exton, PA (on-site) · The Manufacturing Engineering Manager will provide purpose, direction, and motivation while operating to accomplish the goals and improving the Manufacturing Engineering Group. They will provide guidance and experti ...
-
Manufacturing Engineering Manager, NPI
4 weeks ago
dsm-firmenich Exton, United StatesManufacturing Engineering Manager, NPI · Exton, PA (on-site) · The Manufacturing Engineering Manager will provide purpose, direction, and motivation while operating to accomplish the goals and improving the Manufacturing Engineering Group. They will provide guidance and expert ...
-
Manufacturing Engineering Manager, NPI
2 weeks ago
dsm-firmenich Exton, United StatesManufacturing Engineering Manager, NPI · Exton, PA (on-site) · The Manufacturing Engineering Manager will provide purpose, direction, and motivation while operating to accomplish the goals and improving the Manufacturing Engineering Group. They will provide guidance and experti ...
-
Manager Manufacturing
1 day ago
WuXi AppTec Philadelphia, United StatesOverview · Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Go ...
-
Manufacturing Engineering Manager
3 weeks ago
Stealth Recruiting Services Chester, United States145k to 155k · **Job Description**: · Manufacturing Engineering Manager · Experience in mentoring and managing 2 - 5 Mfg Engineers with emphasis on Lean or Continuous Improvement projects in addition will develop them · - help get more out of the team and take them to next level. ...
-
Manufacturing Production Manager
1 week ago
McCallion Staffing Montgomeryville, United StatesThe successful candidate will be responsible for overseeing all aspects of manufacturing plant management, including production, logistics and supply chain management, quality control, equipment maintenance, and staff management, ensuring efficient operations and alignment with o ...
-
Manufacturing Engineering Manager
1 day ago
Actalent Bridgeport, United States: The Manufacturing Engineering Manager will engage with their team to lead the manufacturing engineering activities and initiatives across. Additionally, the role will drive process and quality improvements, improved yields, and overall cost and productivity. This position is re ...
-
Manufacturing Engineering Manager
2 days ago
Client Growth Resources, Inc Reading, United States· TITLE: Manufacturing Engineering Manager · ENVIRONMENT: Industrial Manufacturing · LOCATION: Reading, PA · REPORTS TO: Vice President of Operations · COMPENSATION RANGE: Competitive Compensation Plan · DEGREE REQUIREMENTS: Bachelor's in engineering(link removed) Advanced ...
-
Manufacturing Engineering Manager
1 week ago
Image Associates Inc Philadelphia, United StatesLocal process measurement instruments manufacturer needs a Manufacturing Engineering Manager to coordinate activities in the department. Manage engineers who develop systems for product fabrication and mechanical assembly. Provide engineering management in support of improved pro ...
-
Manufacturing Engineer Manager
1 week ago
Surf Search Pennsville, United States Full timeNew Life is seeking a Manufacturing Engineer Manager who can take on the following responsibilitiesDesigns, integrates, and improves manufacturing systems or related processes. Must possess excellent "hands-on" mechanical and organizational skills. At least 5 years related work e ...
Manager Manufacturing - Exton, United States - Frontage Laboratories
Description
Job Description
Job DescriptionManufacturing Manager
Title: Manager, Manufacturing Operations
Location: Exton, Pennsylvania
Reports to: Vice President, PD & Manufacturing
Full-time
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. 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:
Education, Experience & Skills Required:
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.
