Enzene - Manufacturing Associate I, Downstream Operations

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

There are three levels of Manufacturing Associate (I, II, III). The Manufacturing Associate I will be responsible for the day-to-day operations of downstream processing in a clean room environment. This role includes buffer and media preparation, chromatography, tangential flow filtration (TFF), viral filtration, and aseptic processing.

Key Responsibilities:

• Buffer and Media Preparation: Prepare and maintain buffers and media required for downstream processes. Ensure accurate formulation and timely availability of all solutions. Maintain detailed records of preparation and usage.

• Chromatography: Operate and maintain chromatography systems for protein purification. Monitor process parameters and ensure consistent product quality. Troubleshoot and resolve any issues that arise during chromatography runs.

• Tangential Flow Filtration (TFF): Perform TFF operations for concentration and diafiltration of biopharmaceutical products. Optimize TFF parameters to achieve desired product specifications. Document all TFF activities and results.

• Viral Filtration: Conduct viral filtration to ensure the safety and purity of biopharmaceutical products. Validate and monitor viral filtration processes. Maintain compliance with regulatory standards for viral safety.

• Aseptic Processing: Perform aseptic processing in a clean room environment. Adhere to strict aseptic techniques to prevent contamination. Ensure compliance with Good Manufacturing Practices (GMP).

• Clean Room Operations: Maintain a clean and organized work environment. Follow all clean room protocols and procedures. Participate in regular clean room maintenance and cleaning activities.

• Documentation and Compliance: Maintain accurate and detailed records of all manufacturing activities. Ensure compliance with GMP and regulatory requirements. Participate in audits and inspections as needed.

• Leadership (as appropriate for level of role): Lead daily manufacturing operations, ensuring production targets are met while maintaining high standards of quality and efficiency. Ensure team adherence to standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) regulatory and safety regulations. Provide training, guidance, and performance feedback to team members. Lead and mentor members within your team, providing guidance, support and feedback to ensure overall effective performance and continuous improvement.

Qualifications

• Education and Experience: Bachelor's degree in biotechnology, Biochemistry, Chemical Engineering, or a related field with 0+ years of relevant experience (H.S diploma with 4+ years of experience will be considered in lieu of Bachelors Degree).

• Skills: Ability to follow instructions and procedures. Experience with buffer and media preparation, chromatography, TFF, viral filtration, and aseptic processing a plus. Excellent problem-solving and analytical skills. Effective communication, leadership and teamwork abilities. Strong knowledge and experience working in a biopharmaceutical cGMP- regulated environment. This position requires the ability to stand for extended periods, bend, and lift objects weighing up to 50 pounds. Candidates must be physically capable of performing these tasks safely and effectively.

Salary Range: $25.48 - $32.21 per hour

Benefits:

• Health Insurance (Medical, Dental, Vision)

• Life and AD&D Insurance

• Disability Insurance (LTD & STD)

• 401k Retirement Plan

• Paid Time Off

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.