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Upstream Manufacturing Associate (Multiple Levels & Roles)

2+ years
Not Disclosed
10 Jan. 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Upstream Manufacturing Associate (Multiple Levels & Roles)
Company: Enzene
Location: Hopewell, New Jersey, United States

About Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational presence in India. As a subsidiary of Enzene Biosciences, a leading biotechnology company, Enzene is dedicated to providing high-quality biologics manufacturing services to clients and advancing the pharmaceutical industry.

Website: www.enzene.com

Position Overview
The Upstream Manufacturing Associate will be responsible for the day-to-day operations of upstream processing in a clean room environment. Depending on the level, this role involves 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, and maintain detailed records.
  • Cell Culture: Operate and maintain cell cultures in flasks, bioreactors, and perfusion reactors. Monitor process parameters to ensure consistent product quality and troubleshoot issues during vial thaw and cell expansion.
  • Aseptic Processing: Perform aseptic processing in a clean room environment. Follow strict aseptic techniques to prevent contamination and ensure compliance with Good Manufacturing Practices (GMP).
  • Clean Room Operations: Maintain an organized and clean environment by following clean room protocols. Participate in clean room maintenance and cleaning activities.
  • Documentation and Compliance: Maintain accurate manufacturing records and ensure compliance with GMP and regulatory requirements. Participate in audits and inspections as required.
  • Leadership (As appropriate): Lead manufacturing operations, ensuring production targets are met with high-quality standards. Mentor team members, provide feedback, and ensure adherence to SOPs, GMP, and safety regulations.

Qualifications

  • Education and Experience: Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, or a related field (0+ years of relevant experience for junior roles). For senior roles, 4+ years of relevant experience is required (H.S. diploma with 4+ years of experience considered in lieu of a Bachelor's degree).
  • Skills: Ability to follow instructions and procedures. Experience in buffer/media preparation, chromatography, TFF, viral filtration, and aseptic processing is a plus. Strong problem-solving and analytical skills, effective communication, and teamwork abilities. Familiarity with biopharmaceutical cGMP-regulated environments is essential. Physical capability to lift up to 50 pounds, stand for long periods, and bend as required.

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, improving processes, and enhancing patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence. We offer a dynamic work environment with growth opportunities in an industry 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.