Upstream Manufacturing Associate
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Apply Now Application ends in 26d 23h 29min
Job Detail
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Offered Salary 0
Job Description
Job Description
The manufacturing associate will provide hands-on technical support for all aspects of cGMP cell therapy manufacturing, including technology transfer, process validation, and process support. This role involves working in both team-oriented and individual environments, monitoring process performance at the contract manufacturing organization (CMO), and ensuring the successful delivery of products with regard to time, quality, and budget.
Responsibilities
- Review and monitor cell culture and aseptic processing activities performed at CDMOs.
- Review and monitor GMP developmental and commercial manufacturing operations.
- Provide Quality Assurance (QA) with technical support for process discrepancies and deviation investigations.
- Plan and track domestic and international GMP and non-GMP material shipments.
- Assist in planning, writing, and managing the execution of cGMP manufacturing protocols, batch records, SOPs/WIs, and plans.
- Prepare manufacturing/campaign reports.
- Accountable for the integrity and tracking of cGMP manufacturing department process data.
- Accurately and timely manage the tracking of all cGMP material and cell bank inventories.
- Coordinate and track lot release testing samples.
- Assist with technical support for CDMO GMP manufacturing activities.
- Maintain cGMP cell bank and product inventories.
- Liaise with functional groups and sub-contractors.
- Report progress to supervisors and attend progress meetings regularly.
- Maintain familiarity with current and emerging technologies through reading scientific and technical literature.
- Comply with quality systems and all pertinent safety policies, rules, and regulations.
Essential Skills
- Cell culture
- Aseptic processing
- GMP
- Tissue culture
- Flask
- Hyper Stack
- Cell Factory
- GDP
- Cell Therapy
- Gene Therapy
- Scale-Up
- Manufacturing
- Biotechnology
- 3D Cell Culture
Additional Skills & Qualifications
- BS or MS degree in Biology or related discipline, or an associate degree in a life science discipline.
- Understanding of cell and molecular biology techniques for the identification and validation of drug targets.
- 2-5 years of biotechnology or pharmaceutical cGMP manufacturing experience, preferably in cell or gene therapy.
- Experience with cGMP aseptic processing and tissue culture using Flask, Hyper Stack, Cell Factory, and 3D cell culture is preferred.
- Strong interpersonal, attention to detail, communication, and organizational skills.
- Good documentation (GDP) and organizing skills are recommended.
- Self-directed and self-motivated with the ability to work both independently and as a team member in a matrix environment.
- Exceptional oral and written English communication skills.
Apply Now
Application ends in 26d 23h 29min