Downstream Manufacturing Scientist
2 weeks ago
Description: 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 and clinical 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.Essential Duties & ResponsibilitiesPerform 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.Presents to the department, company or others, updating status of internal projects and process.Writes batch records, protocols, routine reports and other technical documents.Ability to interpret and provide instructions furnished in written, oral, diagram, or schedule form.Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.Review executed manufacturing and packaging batch records, executed and associated supporting documents.Coordinate the conduction of investigations and corrections for issues found during the batch execution process.Performs other functions as required or assignedComplies with all company policies and standards Requirements Education:Requires a Bachelor or Master' degree in chemical, biological or biochemical sciences and a minimum of 1-2 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.Special Skills: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 sheetKnowledgeable in GMP batch manufacturing and packaging documentation; audit and review.Knowledgeable in cleaning verification/validation. Work Environment & Physical Demands:General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.Employment Type: ContractorSalary: $ 35.00 40.00 Per Hour
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Downstream Manufacturing Scientist
2 weeks ago
Piscataway, United States Sai Krishna Full timePosition SummaryThe 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...
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Downstream Manufacturing Scientist
5 days ago
Piscataway, United States Kashiv Biosciences LLC Full timeJob TypeBe one of the first applicants, read the complete overview of the role below, then send your application for consideration. Full-time, Contract Description 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...
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Upstream Manufacturing Scientist
1 week ago
Piscataway Township, United States Kashiv BioSciences Full timeApply Job Type Full-time Description Position SummaryThe Upstream Manufacturing Scientist is responsible for executing mammalian cell culture processes and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible for executing cell culture batches from L to 0 L volumes engineering and clinical batches...
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Manufacturing Associate
2 weeks ago
Piscataway, United States Sai Krishna Full timeJob Summary:Manufacturing associate is a hands-on position responsible for executing buffers and media for the upstream and downstream manufacturing process. The candidate will be responsible in the preparation of buffers related to all the manufacturing scale for engineering, clinical and commercial batches in a cGMP environment. This position requires...
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Urgent Need: Manufacturing associate I
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Piscataway, United States Unicon Pharma Full timePosition Summary Manufacturing associate I is a hands-on position responsible for executing buffers and media for the upstream and downstream manufacturing process. The candidate will be responsible in the preparation of buffers related to all the manufacturing scale for engineering, clinical and commercial batches in a cGMP environment. This position...
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Research Scientist
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Research Scientist
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