Job Description

Business Description

The Biologics Clinical Operations & External Partnerships (BCO & EP) department is responsible for the production of Biologics Drug Substance (DS) clinical supplies at 3rd party contract manufacturing organizations (CMO’s), Drug Product/Drug Substance (DPDS) internal sites, and Innovative Medicine Supply Chain (IMSC) internal sites. The Malvern Clinical Operations (MCO) team is responsible for manufacturing the Biologics DS (drug substance) clinical supplies at the Malvern manufacturing site. The NPI Coordinator position in Malvern is responsible for delivery of the NPI process to the manufacturing site for New Molecular Entities (NME’s), resupplies and phase changes of API clinical materials per Chemistry, Manufacturing, & Controls (CMC) timelines.

Objectives & Responsibility

New Product Introduction (NPI) Tech Transfers

• Accountable for successful new production introduction (NPI) tech transfers into the manufacturing area to enable GMP production of DS clinical supplies
• Setup and lead project kickoff meetings, weekly work-cells, and other tech transfer meetings, as necessary, to coordinate efforts among Operations and other cross-functional departments
• Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders
• Lead Process-Fit-to-Plant evaluations and Process Capability Assessments (PCA) of new programs with cross-functional departments, as needed
• Track and trend NPI tech transfer performance, and identify then implement continuous improvement projects to enhance the tech transfer process
• Act as the single point of contact (SPOC) between CMC teams, Clinical Supply Chain (CSC) teams and the Site Operations team, regarding tech transfer and GMP DS clinical supplies updates
• In collaboration with Site Operations and Quality, review and approve required GMP documentation for manufacturing production, when necessary

Site Manufacturing Management and Relationships

• Prioritize and schedule activities to support business needs and to meet the requirements of Master Production Schedule
• Initiate and execute change controls and work with management to allocate group resources, assuring regulatory compliance and technical feasibility of proposed changes
• As accountable SPOC, partner with site operations, API Proteins, and other cross-functional colleagues to ensure on-time, end-to-end supply chain delivery of GMP DS Clinical Supplies to the CMC team
• Partner with the Global Planning organization in the planning of production schedules and capacity within the network; Determine the impact of forecast changes on scheduling and cost
• Partner with Clinical supply chain planning for material demand planning for all programs including safety stock and consumptions
• Prepare manufacturing business plan forecasts and monitor actual spend vs. budget

Qualifications and Skills Required:

• A Bachelor’s Degree in the Life Sciences or Engineering is required
• A minimum of 2 years of project management experience required
• A minimum of 3 years of experience within a GMP regulated environment or pharmaceutical industry is required
• Experience in clinical or commercial biologics Drug Substance (DS) manufacturing is required
• Understanding of planning, material handling, manufacturing, and GMP-compliance related to the manufacturing of biopharmaceuticals is required
• Ability to effectively apply project management tools to lead projects and programs is required

Qualifications and Skills Preferred:

• Understanding of manufacturing cost drivers is preferred; Previous budget experience is preferred.
• Experience with the cell culture or purification processes in either a manufacturing or a lab-based environment is preferred
• Experience with technical transfers of NPI’s is preferred
• Familiarity with TruVault, SAP, MES, and COMET is preferred
• Knowledge of FPx (Flawless Project Execution) and Lean methodology is preferred
• Knowledge of cGMP’s and Agency requirements for biopharmaceutical manufacturing is preferred

General

• The position is located in Malvern, Pennsylvania (hybrid)

Compensation:

$30-40/hr

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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