Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • San Diego

Description

Apply Description Position Summary

The Sr. Manufacturing Associate is part of the Poseida internal manufacturing team in support of Poseida’s clinical production of cell therapies. This position will support process transfers, routine GMP production activities, 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:


- Performs Aseptic operations in an ISO Class 5 cGMP environment
- Support production in an aseptic environment
- Assists in the development of manufacturing electronic batch records
- Drafts and revises SOPs
- Manufacturing process equipment SME
- Certified trainer and mentor to manufacturing associates
- Maintain a quality-first mindset by always following batch record instructions, SOPs, Work Instructions, and protocols as written
- Initiates deviations and participates in root cause investigations and CAPA
- Assist in all areas of cell culture and all related duties as required including (stocking, tracking inventory, material movement, maintaining metrics, filling out log sheets, and other special projects)
- Assists in manufacturing batch record review and batch record development for clinical processing
- Identifies and implements continuous improvements
- Executes on production batch records and work orders according to SOPs and protocols.
- Routine maintenance and cleaning of rooms and equipment
- Participate in small projects within manufacturing
- Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
- Adhere to all safety protocols and procedures Requirements Requirements, Knowledge, Skills and Abilities


- Bachelor degree in Biology, Chemistry, or Engineering preferred with 5+ years of related experience (an equivalent combination of education and experience may be considered)
- Biotechnology industry GMP environment experience is preferred
- Ability to follow verbal and written instructions
- Problem Solving skills
- Detail oriented
- Team player
- Strong communication skills
- Strong demonstrated aseptic techniques
- Work is generally performed in a GMP manufacturing facility
- Subject to extended periods of standing (8 hours)
- The position requires a combination of standing in the manufacturing environment and walking around the facility
- Will required weekend, overtime hours, and some holiday work
- 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
- Work may require lifting up to 40 lbs.
- Subject to extended periods of sitting and/or standing in a clean room environment (ISO 7 or 5). Work is generally performed in an office, manufacturing clean room or clinical environment

About the company

NeuvooBulkUS

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