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.
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.
- 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.
- 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 assigned.
- Complies with all company policies and standards.
Requirements
Education and Experience
- 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.
- 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 spread sheet.
- Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
- Knowledgeable in cleaning verification/validation.
