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Upstream Manufacturing Scientist


  • Unicon Pharma Inc
  • 06/28/22
  • Piscataway, NJ
  • 08854
  • $40.00 / Hourly
  • Contractor
Position Summary

The Upstream Manufacturing Scientist is a hands-on position 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 experiments from 15 mL to 1000 L volumes engineering and clinical batches in a cGMP environment. This position requires technical expertise in bioreactor operations, cell biology 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.

Essential Duties & Responsibilities

Perform cell culture and bioreactor operations at multiple scales.
Ensure that engineering and clinical batches are executed in a timely manner.
Establishes operating equipment specifications and improves manufacturing techniques.
Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment.
Determines and may assist in developing methods and procedures to control or modify the manufacturing process.
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.
Perform other duties as required of the Manufacturing Team.
Position Requirements and Qualifications

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 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

Specialized Knowledge and 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 sheet
Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
Knowledgeable in cleaning verification/validation.

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