Project Coordinator Job Listing at Kelly Services in Malvern, PA (Job ID US3628692_BH10036075)

Description

Project Coordinator

Kelly Services is currently seeking a Project Coordinator for one of our top clients in Malvern, PA.

• Kelly Outsourcing Consulting Group KellyOCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Content Manager for a 12 month +  engagement at one of our Global clients in Malvern, PA.
• As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from.
• You'll also be eligible for paid time off, including holiday, vacation and sick/personal time.
• All KellyOCG employees receive annual performance reviews.

We are seeking a Project Coordinator to join our New Product Introduction (NPI) team in Malvern, PA.  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.   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

Important information: This position is recruited by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States.
 
Why Kelly®
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


As a Kelly Services employee, you will have access to numerous perks, including:

• 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

 
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.


 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Find what's next with Kelly®.

As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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