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. 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. • 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. Position Requirements and Qualifications 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.

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