Downstream Manufacturing Scientist
About The Position
The Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents. Work in a team environment to execute batches and can work independently with minimum supervision. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.
Requirements
- Requires a Bachelor or Master’ degree in chemical, biological or biochemical sciences and a minimum of 4- 5 years of related experience in the biopharmaceutical industry.
- Previous experience working in GMP and aseptic manufacturing environment.
- Experience working with AKTA Process skids or similar and familiarity of single use manufacturing consumables such as bags, tube sets, columns and process manifolds.
- Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation.
- Ability to work with other team members and independently - good interpersonal skills.
- Good communication skills: verbal and written, good computer and organization skills, detail oriented.
- Basic computer skills, including knowledge of Word, Excel and spread sheet
- Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
- Knowledgeable in cleaning verification/validation.
Responsibilities
- Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
- Provides technical direction in the execution and development of the purification process.
- Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment.
- Ensure that engineering and clinical batches are executed in a timely manner.
- Establishes operating equipment specifications and improves manufacturing techniques.
- Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
- Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.
- Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
- Performs other functions as required or assigned
- Complies with all company policies and standards
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
