Manufacturing Scientist
1 month ago
Position Summary
The 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 50 L to 1000 L volumes engineering and clinical batches in a cGMP environment.
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.
- Ability to interpret and provide instructions furnished in written, oral, diagram, or schedule form.
- 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.
Education and Experience Requirements
- Requires a Bachelor or Master’ degree in chemical, biological or biochemical sciences and a minimum of 3+ years of related experience in the biopharmaceutical industry.
- Previous experience working in GMP and aseptic manufacturing environments.
- Experience working with single use manufacturing consumables such as bags, tube sets, columns and process manifolds.
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 spreadsheet.
- Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
- Knowledgeable in cleaning verification/validation preferred.
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