What are the responsibilities and job description for the DSP Manufacturing Associate position at Pharma Universe?
This dynamic role is integral to the purification of mammalian cell-based cultures and the production of recombinant proteins for a variety of mammalian-based biosimilars. The position involves purifying volumes from 50L to 1000L for engineering, clinical, and commercial batches in a cGMP environment.
The successful candidate will possess extensive technical expertise in AKTA purification skids or similar systems, tangential flow filtration (TFF), and a thorough understanding of batch records, protocols, investigations, and other technical documents.
Essential Duties & Responsibilities:
- Perform and oversee downstream processes at various scales in a cGMP environment, including column packing, process troubleshooting, and data analysis.
- Provide technical guidance in the execution and development of the purification process.
- Utilize programs to collect and assess operating data, making online adjustments to products, instruments, or equipment as needed.
- Prepare and review all quality management-related documents (Deviation, Change control, investigation reports, etc.).
- Ensure timely execution of engineering and clinical batches.
- Establish operating equipment specifications and enhance manufacturing techniques.
- Collaborate with other teams and external vendors to resolve technical issues and maintain production equipment.
- Adhere to GMP instructions in the manufacturing area and lead compliance with environmental health and safety policies.
- Coordinate investigations and corrections for issues identified during the batch execution process.
- Perform additional functions as required or assigned.
- Comply with all company policies and standards.
Requirements:
- Education: Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences with 8-12 years of related experience in the biopharmaceutical industry.
- Prior experience in GMP and aseptic manufacturing environments.
- Experience with AKTA Process skids or similar systems, and familiarity with single-use manufacturing consumables (e.g., bags, tube sets, columns, process manifolds).
- Proficiency in executing engineering and clinical batches and familiarity with GMP documentation.
Work Environment & Physical Demands:
- General work environment and physical demands necessary to perform essential functions.
- Flexibility to work varied hours as needed.
- Ability to work under pressure and meet deadlines.
- Some travel may be required.
