Quality Control Manager

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
Quality Control Raw Material Manager will ensure that the raw materials and consumables used in production meet the required quality standards.

Key Responsibilities

• Oversight: Oversee or execute the inspection, sampling and testing of incoming raw materials and consumables. Manage technology transfer of raw materials and consumables test methods.
• Compliance: Design and implement Raw Materials Qualification program in compliance with FDA and EMA regulations. Ability to conduct risk assessments and implement risk mitigation strategies for raw materials.
• Manage laboratory activities: Oversee or execute testing as needed on incoming raw materials and consumables, review the associated data, maintain accurate records of all inspections, test, vendor notifications and supplier evaluations.
• Problem Solving: Resolve technical problems in the lab. Lead investigation for out of specification results and deviations. Implement continuous improvement initiatives to optimize raw material testing and release.
• Team Leadership: Train laboratory personnel to ensure they are well versed in raw material and consumable test methods.
• Documentation: Author procedures, specifications, risk assessments, protocols and summary reports. Manage all raw material QMS documents including change controls.
• Data Management: Oversee the management and storage of raw material/consumable testing data, review to ensure it is accurate, securely stored and easily retrievable. Analyze data to identify trends and propose areas for improvement.
• Client and Audit Management: Subject matter expert in raw material/consumables for regulatory and client audits for GMP compliance.

Qualifications

• Education: This role requires strong work experience in analytical and sterility assurance testing technologies with a BSc or higher in chemistry, industrial engineering or related fields. Advanced degrees or additional certifications in relevant field preferred.
• Experience: At least 7-10 years of experience in a leadership role within pharmaceutical or biotechnology industries and 3-5 years of leadership role in raw material testing and release. Significant experience working in a Good Manufacturing Practice (GMP) and Good Laboratory Practices (GLP) environment is crucial. Proficiency in quality control software including LIMS and data analysis tools.
• Skills: Proficiency in analytical techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC) and mass Spectrometry (MS). Knowledge of Endotoxin and Sterility Assurance test methods.

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.

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Raw Material Testing: 3 years (Required)
• Leadership in Pharmaceutical or Biotechnology Industry: 7 years (Required)

Ability to Commute:

• Hopewell, NJ 08525 (Required)

Ability to Relocate:

• Hopewell, NJ 08525: Relocate before starting work (Required)

Work Location: In person