Enzene - Manufacturing Lead, Downstream Operations - 1130 Works
Hopewell, NJ
About the Job
About Our Client - Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.
Website: www.enzene.com
Position Overview
The Manufacturing Lead in Downstream Operations will be responsible for executing and managing downstream processing operations, including chromatography, filtration, and sterile filtrations. The candidate will also ensure strict adherence to GMP, EHS, and quality documentation standards while playing a key role in maintaining batch performance and compliance. Additionally, this role includes day-to-day task scheduling, training of junior staff, and acting as a liaison between MSAT, supply chain, and Quality Assurance (QA).
Key Responsibilities
- Downstream Processing Operations: Execute and operate downstream batch activities, including chromatography (e.g., AKTA process), ultrafiltration/diafiltration (UF/DF), and sterile filtrations. Operate key downstream processing equipment such as TFF systems, filter integrity check machines, autoclaves, and column packing stations. Manage buffer preparation and filtration activities. Monitor batch performance, collect and analyze data, and provide recommendations for process improvement.
- Task Scheduling: Develop and manage daily and weekly schedules for downstream processing activities. Coordinate with cross-functional teams to ensure timely completion of tasks. Adjust schedules as needed to accommodate changes in production priorities or equipment availability.
- Training: Train and mentor junior staff on downstream processing techniques and equipment operation. Develop and update training materials and SOPs. Ensure all team members are compliant with GMP and EHS guidelines.
- Liaison Responsibilities: Act as a primary point of contact between MSAT, supply chain, and QA departments. Facilitate communication and collaboration to resolve issues and improve processes. Ensure alignment of downstream operations with overall production goals and quality standards.
- Documentation & Compliance: Author departmental SOPs and WI and create master batch records based of MSAT provided technical transfer documentation. Author or support the creation of relevant documentation, including deviations, change controls, and risk assessments, in compliance with Quality Management Systems (QMS). Ensure GMP compliance in all downstream operations, adhering to defined SOPs and regulatory requirements.
- Equipment & Process Qualification: Participate in the qualification and validation of downstream processing equipment. Ensure the proper operation and maintenance of single-use mixers and other downstream equipment.
- GMP & EHS Adherence: Follow and implement Good Manufacturing Practices (cGMP) in all areas of responsibility. Adhere to Environment, Health, and Safety (EHS) guidelines within the workplace.
Qualifications
- Education: Bachelor’s Degree in Biotechnology, Biochemistry, or a related field.
- Experience: 5-10 years of relevant experience.
- Skills: Experience working in a cGMP-regulated environment, particularly in biopharmaceutical production. Expertise in downstream processing, including mammalian-based biopharmaceutical production processes. Strong team player with the ability to collaborate cross-functionally. Strong interpersonal and communication skills, capable of working with internal and external stakeholders.
Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.
We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.
Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.