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TEMP - Process Development Associate

Job Description

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Job Type
Temporary
Description

**Please note that this is a 40 hour a week temporary role.


Your Impact

Our tight-knit, agile, and fun MSAT 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 continuous process improvements and supporting successful manufacturing of clinical material that will drive Poseida's mission to cure patients of cancer. 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

Process Development Associate I to join our MSAT team to support both early/ late-stage development and manufacture of Poseida's allogeneic cell therapy programs. The position will interface cross functionally with technical teams including Process Development, Analytical Development, and Manufacturing Operations.


Responsibilities may include but are not limited to:

  • Monitor and analyze manufacturing data as needed to provide support for process improvement and investigations
  • Work closely with the Process Development team to assure process reliability and robustness in preparation for comparability
  • Participate and support process FMEAs to understand process and product risks
  • Participate and support investigation, impact assessment for major deviations, identify root cause for critical deviations to maintain routine manufacturing operations and determine process improvements for manufacturing.
  • Write and/or review technical documentation (SOPs & reports for comparability)
  • Maintain data tracking systems (primarily using Microsoft Excel and Skyland PIMS) for clinical manufacturing process data and process development data, including collaborating with external partners
  • Perform data entry by transferring data from paper or electronic formats into internal database systems
  • Work flexible hours, when needed, to support and cover production activities as remote support role
  • Other duties as assigned
Requirements

Requirements, Knowledge, Skills and Abilities

  • Bachelor's Degree in Biochemical Engineering, Biotechnology or relevant scientific discipline with 0-2 years of experience (an equivalent combination of education and experience may be considered). The ideal candidate will have pharmaceutical manufacturing, technology transfer & process development experience, preferably.
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals preferred
  • Technical writing and protocol/report writing is a plus
  • Experience in statistical analysis using JMP
  • Knowledge of data management tools and statistical process controls
  • Previous experience with cell culture and/or cell therapy products is a plus
  • Understand manufacturing needs and adapt to the changing needs of the manufacturing environment
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills
  • Excellent interpersonal, verbal, and written communication skills
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Well-developed computer skills


Position Title Pay Rate: $31.73/hour to $39.90/hour

The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc.


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!


Recruitment Fraud Alert

Alert: Beware of Employment Scams


Poseida Therapeutics, Inc. has received reports of employment-related scams. These scams have appeared in forms of false job advertisements and/or unsolicited contacts via communication/chat platforms, phone, email or text from individual(s) claiming to be or represent Poseida's Human Resources team. Be advised that Poseida Therapeutics does not extend unsolicited employment offers. Furthermore, Poseida Therapeutics does not request payment information or charge prospective employees with any fees during the recruitment process.


If you would like to pursue employment opportunities with Poseida Therapeutics, Inc., please visit our official careers website https://poseida.com/careers-culture/ or official Poseida Therapeutics LinkedIn page. Job postings that do not link directly to our careers website or official Poseida LinkedIn page are not legitimate and might be fraudulent. You may report fraudulent job advertisements or contacts via our Contact Us page at https://poseida.com/contact-us/ and select the subject "Careers." If you have been defrauded or suspect identity theft as a result of an employment scam, please contact your local law enforcement agency for guidance.

 

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