Kashiv Biosciences

Job Type

Full-time

Description

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, bioreactor operations and harvesting process 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.
• Should have in-depth upstream knowledge to trouble shoot problems as and when required.
• 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

Position Requirements and Qualifications Education and Experience

• Requires a Bachelor or Master’ degree in chemical, biological or biochemical sciences and a minimum of 10+ years of related experience in the biopharmaceutical industry.
• Expertise in upstream process (cell expansion, harvest procedures)
• 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 bioreactor or SS bioreactor is must.

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.

Work Environment & Physical DemandsWork 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.Supervisory Responsibility, if any: Yes.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.