Upstream Manufacturing Scientist

Position Summary

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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.

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

• Work with a collaborative team of manufacturing associates and engineers to execute upstream batches.
• Perform cell culture and bioreactor operations at multiple scales.
• Ensure that engineering and clinical batches are executed in a timely manner.
• Establish operating equipment specifications and improve manufacturing techniques.
• Use 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.
• 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 functions as required or assigned.
• Comply with all company policies and standards.

Education and Experience

• Requires a Bachelor or Master’s degree in chemical, biological or biochemical sciences and a minimum of 3+ years of related experience in the biopharmaceutical industry.
• Expertise in independently conducting and directing the design, execution, analysis, and documentation of all states of process development.
• Strong fundamental knowledge and subject matter expertise to execute engineering and clinical batches.
• 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.

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 spreadsheets.
• Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
• Knowledgeable in cleaning verification / validation.

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