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Manufacturing Associate

Company: Poseida Therapeutics, Inc.
Location: San Diego
Posted on: May 16, 2022

Job Description:

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Description

We are hiring for several Manufacturing Associate positions - we invite you to apply today!

Please note that working one weekend day (Saturday or Sunday) and overtime work is expected for this position.

Your Impact

Our tight-knit, agile, and fun pilot plant team is looking for someone who has a strong work ethic and wants to be a part of a collaborative team. In this role, you will have a direct impact in generating clinical material that will drive Poseida's mission to cure patients of cancer. This individual will perform GMP manufacturing operations to manufacture quality final product. You will have an opportunity to learn and advance in your career as this group is forward thinking and fully supportive of development. We understand the meaning of team and are looking for an individual that wants to be a part of something bigger and a driving force in changing the lives of cancer patients.

Position Summary

The Manufacturing Associate is part of the Poseida internal manufacturing team in support of Poseida's clinical production of cell therapies. This position will support front line non-viral cell therapy GMP production activities, process transfers, and technology improvements towards the successful delivery of released product to meet the needs of Poseida's clinical trials.

Responsibilities

These may include but are not limited to:

* Perform critical GMP aseptic operations in ISO 5 and ISO 7 production environments, following paper-based and/or electronic batch records, standard operating procedures (SOPs), policies, and work instructions to ensure safe and compliant operations
* Assist with startup activities of a new cGMP facility by collaborating with PD, MSAT, Facilities, and Quality departments
* Support training activities in the Manufacturing group.
* Escalate processing and equipment issues, as needed. Participate in deviation writing, root cause investigations, and CAPAs when necessary
* Work as part of a team to execute GMP operations in close collaboration with Supply Chain, Process Development, Facilities and Quality departments
* Ensure a right-the-first-time philosophy of all process steps and documentation, as well as help drive the safety-first culture at Poseida
* Meticulously adhere to all SOPs, Work Instructions, and cGMP regulations; accurately complete documentation associated with clinical manufacturing
* Assist in procedures and SOP's development when necessary.
* Assist in all areas of cell therapy operations and all related duties as required including (stocking, tracking inventory, material movement, maintaining metrics, filling out log sheets, and other special projects)
* Operate bench top equipment including tubing welders, tube sealers, cell counters, centrifuges, and other cell therapy process equipment.
* Always ensure critical thinking with the goal of optimizing and improving processes/procedures
* Routine maintenance and cleaning of cleanrooms, manufacturing support areas, and equipment
* Participate in small projects within manufacturing
* Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements

Requirements

Requirements, Knowledge, Skills and Abilities

* Bachelor's degree in biology, Chemistry, or Engineering preferred OR 2+ years of related GMP experience (an equivalent combination of education and experience may be considered)
* Biotechnology industry GMP environment experience is preferred. Prior experience with cell or gene therapy manufacturing is a plus
* Excellent skills in Microsoft Word, Excel, and Power Point
* Self-motivated, positive, and willing to accept temporary responsibilities outside of initial job description
* Willingness to think outside of the box as well as comfortable in a fast-paced and constantly evolving environment
* Day shift with weekend work required.
* Will require work off shift hours, weekends, and some holiday work
* Ability to follow verbal and written instructions
* Problem Solving skills
* Detail oriented
* Team player
* Strong demonstrated aseptic techniques
* Work is generally performed in a GMP manufacturing facility
* Able to lift 40 pounds and stand for hours at a time
* The position requires a combination of standing or sitting in a cleanroom manufacturing environment as well as walking around the facility
* Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body

Who We Are and What We Do

Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single treatment cures for patients in need. Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics.

At Poseida we put people first. Our team is passionate about improving patients' lives through innovation. See what our team has to say about our culture:

"My favorite part about Poseida is all the people that I get to work with. Everyone is so passionate about what we're doing here and there's so much camaraderie. It feels like one big enthusiastic family."

"My favorite part about working at Poseida is the amazing culture and working environment. Everybody is friendly, professional, collaborative, and has a remarkable can-do and positive attitude."

As we advance our compelling pipeline, there are endless opportunities for impact and growth. We encourage you to apply today!

Keywords: Poseida Therapeutics, Inc., San Diego , Manufacturing Associate, Other , San Diego, California

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