Clinical Manufacturing Specialist
Edison-New Brunswick Metro Area, NJ
This position is responsible for cGMP Clinical Manufacturing Operations, drug product process development, process characterization, scale-up, and technology transfer activities of small molecule drug products (includes small molecule parenteral drug products) for the development of new pharmaceutical products. This position supports Vendor Readiness for non-GMP and GMP related activities in alignment with Drug Product Development (DPD) organizational goals and objectives.
Responsibilities will include, but are not limited to, the following:
o Key member of a dynamic scientifically driven team, dedicated to the development and optimization of robust clinical manufacturing processes for the drug products.
o Executes a defined Drug Product Development Vendor Readiness process (due diligence, selection, onboarding, and monitoring) that enables compliance, speed, flexibility, and consistency of practice within the DPD vendor network.
o Manage relationships with Contract Research/Contract Manufacturing Organization to ensure productive and beneficial interactions.
o Maintains an appropriate pool of CRO/CMOs partners to respond to current and anticipated external contracting needs for drug product development and clinical supply manufacturing activities.
o Monitor, compile relevant metrics, and report on Vendor performance (technical, operational, compliance, adherence to timelines) and utilization rate of Contract Research/Contract Manufacturing Organization to internal stakeholders.
o Setup and prepare for periodic business review meetings with these external partners for performance review and to enable continuous improvement.
o Serve as a resource to internal stakeholders by providing guidance on Contract Research/Contract Manufacturing Organization s regional and global capabilities and industry trends.
o Coordinates the Request for Quotation (RFQ) process. Reviews quotations from suppliers and participates in a collaborative, cross-functional supplier selection process.
o Under the appropriate level of supervision, coordinate the implementation and management of Confidentiality Agreements (CDAs), Master Service Agreements (MSAs), and Quality Agreements (QAs) for the DPD vendor network to cover IP protection, supply terms and conditions, and Quality requirements.
o Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
o Implement department policies and work practices related to Vendor Readiness; provide communication and training of policies / processes to DPD staff
o Prepare technical reports, due diligence reports, publications and oral presentations.
Degree in Chemical Engineering, Pharmaceutics, Chemistry or Material Science or a relevant scientific discipline:
o Ph.D., and 0-2 years of relevant experience
o M.S. and 2 - 4 years of relevant experience
o B.S. and 4 - 6 years of relevant experience
o Background in pharmaceutical development as it relates to formulation development and process development/optimization.
o Demonstrated knowledge of cGMPs during pharmaceutical development and clinical/commercial manufacturing.