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CTM Associate (Clinical Trial Manufacturing)

Holly Springs, NC 27540

Posted: 04/08/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 603321 Is job remote?: No Country: United States

Job Description

Target PR Range: 23-33/hr
*Depending on experience

Job Description:

The CTM (Clinical Trial Manufacturing) Associate will be responsible for supporting cGMP readiness and tech transfer activities of early phase clinical trial manufacturing processes. The associate would support the following:
• Authoring/owning cGMP documentation (SOPs, Batch Records) and technical documentation (Gap Assessments, FMEA Assessments, Technical Protocols/Reports, etc.) This function involves creating, revising, and withdrawing documentation, including ownership of related compliance actions.
• Ownership and/or execution of Change Controls (CCs)
• Provide support for generation of SAP material codes and creation of BOM (bill of materials) builds
• Support manufacturing activity for development batches and tech transfer batches
• Support equipment qualification activities

Following Tech Transfer the CTM associate will be responsible for activities to produce cGMP batches which includes:
• cGMP manufacturing (Drug Substance and Drug Product)
• Using SAP for GMP material inventory management (issuance/receiving of materials, cycle counting)
•Ownership/execution of quality based workflows (Deviations/CAPAs). Investigation experience is a plus
• Maintain the CTM area in cGMP compliance, which includes executing routine PMs on process equipment, 5S (area organization and material inventory), and equipment logbook management
• Adherence to gowning requirements of classified areas

Minimum Required Qualifications:
• 1 year experience in pharmaceutical manufacturing, or another similarly regulated environment
• Demonstrated technical writing skills and manufacturing document ownership
• GMP experience preferred (entry level is ok)

Preferred Qualifications / Ideal candidate would have:
• Experience using SAP to manage inventory and work orders
• Experience using QMS software (quality mgmt. systems) such Veeva or Metricstream to own change controls, CAPAs and deviations
• Prior use of LIMS to build and manage sample plans and sample tracking

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Holly Springs, NC

Ready to take the next step in your career? Explore job opportunities in the bustling area around Holly Springs, North Carolina, where growth awaits at every corner. Nestled in the heart of the Tar Heel State, Holly Springs offers a perfect blend of small-town charm and big-city amenities. From its vibrant arts scene at the Holly Springs Cultural Center to the mouthwatering Southern cuisine found at local favorites like the Mason Jar Tavern, this region has something for everyone. Boasting proximity to Raleigh, Durham, and Chapel Hill, as well as being a stone's throw away from attractions like the NC Museum of Art and PNC Arena, Holly Springs provides a unique and attractive environment for professionals looking to thrive. Dive into our job listings today and discover the endless opportunities this lively area has in store for you!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.