Manufacturing Associate

Piper Companies is seeking a highly energetic Manufacturing Associate to support routine manufacturing operations and scaling of cGMP manufacturing at our RTP site. Reporting to the Sr. Manager of Manufacturing, the successful candidate will provide manufacturing, operational, and technical expertise around commissioning, qualification, and start-up documentation. The ideal candidate will have experience in cell or gene therapy and demonstrated ability in a GMP environment. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross-functional relationships.

Key Responsibilities of the Manufacturing Associate:

• Support multiple areas of GMP production as needed.
• Write technical SOPs, batch records, and meet project deadlines/timelines.
• Establish and maintain strong relationships at the site and cross-functionally.
• Contribute to the development and implementation of manufacturing documents (Equipment SOPs and Work Instructions).

Qualifications of the Manufacturing Associate:

• BS or MS in Life Sciences or Engineering with 0-5 years of relevant experience. Technical writing skills are highly preferred.
• Experience with MS Word and Excel is required. Experience with SAP, Veeva QMS, and CMMS is strongly preferred.
• Proven experience in a cGMP manufacturing operation; experience in cell/gene therapy manufacturing operations is strongly preferred.
• Outstanding written and verbal communication skills, with the ability to convey strategies and results to a diverse audience.
• Demonstrated business acumen.
• Dynamic interpersonal skills and the ability to manage through influence.
• Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances.
• High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
• Results-oriented with the ability to demonstrate resiliency, ownership, and drive.
• Willingness to travel for in-person interactions with cross-functional stakeholders to ensure tech transfer is on track as needed.

Compensation for the Manufacturing Associate:

• Competitive salary based on experience: $30-$50/hr, depending on experience
• Comprehensive benefits package including Medical, Dental, Vision, 401k, and sick leave.

Application Details: This job opens for applications on 3/20. Applications will be accepted for at least 30 days from the posting date.

Keywords: Manufacturing, GMP, gene editing, biotechnology, life sciences, cell therapy, gene therapy, SOP, batch records, SAP, Veeva QMS, CMMS, RTP

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