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Manufacturing Associate
2 months ago
Global Life Science Hub is proud to partner with a leading Biopharmaceutical company that specializes in next-generation drug delivery technologies and oral/biosimilar drug development.
This is an exciting time to join a rapidly expanding organization, with brand new in-house Manufacturing capabilities set to triple production in the near future.
Key Responsibilities- Collaborate with a dynamic team of manufacturing associates and engineers to execute upstream production batches.
- Conduct cell culture and manage bioreactor operations across various scales.
- Ensure the timely execution of engineering and clinical batches.
- Develop equipment specifications and enhance manufacturing processes.
- Utilize software to gather and analyze operational data for real-time product, instrument, or equipment adjustments.
- Interpret and follow instructions presented in written, verbal, diagrammatic, or schedule formats.
- Adhere to Good Manufacturing Practices (GMP) guidelines in the manufacturing area and take the initiative to comply with environmental health and safety protocols.
- Review completed manufacturing and packaging batch records, along with related supporting documents.
- Lead the investigation and resolution of issues identified during batch execution.
- Perform additional duties as required or assigned.
- Adhere to all company policies and standards.
- Bachelor's or Master's degree in chemical, biological, or biochemical sciences with a minimum of 3+ years of relevant experience in the biopharmaceutical sector.
- Proficiency in independently planning, executing, analyzing, and documenting all phases of process development.
- Strong foundational knowledge and expertise necessary to manage engineering and clinical batches.
- Previous experience in GMP and aseptic manufacturing settings.
- Must have Scale-Up Bioreactor experience.
- Upstream cell culture process is required, CHO cell is highly desirable.
- Familiarity with single-use manufacturing consumables, including bags, tube sets, columns, and process manifolds.
