Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are seeking a highly motivated, well-organized, and detail-oriented scientist who can work effectively in a fast-paced and multi-disciplinary environment. The position is in the ARD laboratory of Kashiv's Piscataway facility in NJ.
The Upstream Manufacturing Manager is a hands-on position 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.
Education and Experience:
Requires a Bachelor or Master' degree in chemical, biological or biochemical sciences and a minimum of 8+ 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.
Special 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
Work Environment & Physical Demands:
Work with the team, Product Development and other departments to evaluate process and key parameters. Troubleshoot equipment, set up problems and help maintain the manufacturing facility organized and in compliance with the industry standards. Some travel may be involved.
This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.