Enzene - Manufacturing Associate I, Upstream Operations

1130 Works; Hopewell (NJ); On-site; USD 50,000 - 70,000; Full time

Job summary

A rapidly growing biotechnology company seeks a Manufacturing Associate I to oversee upstream processing in a clean room environment. Responsibilities include media preparation, aseptic processing, and ensuring compliance with Good Manufacturing Practices (GMP). The ideal candidate will be detail-oriented and possess a degree in life sciences or equivalent experience, thriving in a collaborative atmosphere determined to advance the industry.

Qualifications

• Education: Bachelor's degree in related fields or H.S diploma with 4+ years of experience.
• Skills: Experience in biopharmaceutical cGMP-regulated environment, ability to lift 50 pounds.

Responsibilities

• Prepare buffers and media for downstream processes.
• Operate and maintain cell cultures in various reactors.
• Perform aseptic processing in a clean room environment.

Skills

Buffer and Media Preparation

Aseptic Processing

Problem-solving

Analytical Skills

Leadership

Communication

Teamwork

Adaptability

Education

Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering or related field

High School Diploma with 4+ years of experience

Job description

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 ofManufacturing Associates within the organization (I, II, III). The Manufacturing Associate Iwill be responsible for the day-to-day operations of upstream processing in a clean room environment. This role includes buffer and media preparation, cell culture, perfusion bioreactors, batch fed bioreactors, harvest operations, 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.

• Cell Culture: Operate and maintain cell cultures in flasks, bioreactors and perfusion reactors. Monitor process parameters and ensure consistent product quality. Troubleshoot and resolve any issues that arise during vial thaw and cell expansion.

• 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.

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.