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Kelly Science, Engineering, Technology & Telecom · 5 hours ago

Project Coordinator

Malvern, PA

Full-time

Onsite

Mid Level

3+ years exp

Kelly Services is currently seeking a Project Coordinator for their New Product Introduction (NPI) team in Malvern, PA. The role involves overseeing the NPI process for new molecular entities, managing tech transfers, and ensuring compliance with GMP production standards.

Staffing & Recruiting

No H1B

Responsibilities

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

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

Qualification

GMP complianceBiopharmaceutical manufacturingProject managementTechnical transfersProcess Capability AssessmentsMaterial handlingCommunication skillsTeam collaborationProblem-solving

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

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

Benefits

Medical

Dental

401K

Paid time off

Holiday

Vacation

Sick/personal time

Annual performance reviews

Vacation and sick pay

Paid holidays

401(k) plan

Group medical, vision, dental, life, and short-term disability insurance options

Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools

Kelly Learning Center offers free courses and trainings

Weekly pay

Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability

Retirement savings plan

Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)

Transit spending account

Paid sick leave under the applicable state or local plan