Upstream Manufacturing Scientist

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 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 & ResponsibilitiesWork 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 ExperienceRequires 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 SkillsAbility 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.

#J-18808-Ljbffr