USP Manufacturing Associate
Location: Piscataway, New Jersey
The Upstream Manufacturing Scientist is responsible for supporting mammalian cell culture processes and producing recombinant proteins for biosimilars. This role involves executing cell culture batches ranging from 50L to 1000L in a cGMP-compliant environment and requires expertise in bioreactor operations, cell biology, and technical documentation practices.
Key Responsibilities
- Execute upstream processes, including cell culture and bioreactor operations at various scales.
- Collaborate with manufacturing associates and engineers to ensure engineering and clinical batches are completed on schedule.
- Develop and optimize manufacturing techniques while maintaining equipment specifications.
- Collect and analyze operational data to make real-time adjustments to processes or equipment.
- Adhere to GMP protocols and environmental health and safety standards in the manufacturing environment.
- Review executed batch records and associated documentation for accuracy and completeness.
- Conduct investigations and implement corrections for issues arising during batch execution.
- Perform additional responsibilities as required, in line with company policies and procedures.
Qualifications
- Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences.
- Minimum of 2 years of experience in the biopharmaceutical industry, with a focus on upstream processes and cGMP environments.
- Demonstrated expertise in executing and documenting process development, engineering, and clinical batches.
- Familiarity with single-use consumables, such as bags, tube sets, columns, and manifolds.
- Strong technical knowledge of cleaning verification/validation and GMP manufacturing documentation.
Skills and Competencies
- Excellent interpersonal and communication skills, both verbal and written.
- Detail-oriented with strong organizational abilities.
- Proficiency in computer applications such as Word, Excel, and spreadsheets.
- Ability to work independently and as part of a team.
Average salary estimate
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