Qc Raw Material Manager

7-10 years

Not Disclosed

Hopewell

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: QC Raw Material Manager
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 footprint in India. A subsidiary of Enzene Biosciences, a leading biotechnology company, Enzene's mission is to provide high-quality biologics manufacturing services that contribute to the advancement of the pharmaceutical industry.

Website: www.enzene.com

Position Overview
The QC Raw Material Manager will be responsible for ensuring that raw materials and consumables used in production meet the required quality standards. This includes overseeing the testing, sampling, and inspection of incoming raw materials, managing qualification programs, and leading the implementation of continuous improvement initiatives.

Key Responsibilities

Oversight: Manage the inspection, sampling, and testing of incoming raw materials and consumables, ensuring all meet required quality standards. Oversee technology transfer of raw materials and consumables test methods.
Compliance: Design and implement Raw Materials Qualification programs in accordance with FDA and EMA regulations. Conduct risk assessments and implement strategies to mitigate potential risks associated with raw materials.
Laboratory Management: Oversee testing activities on incoming raw materials and consumables, review test data, and ensure accurate documentation of inspections, test results, vendor notifications, and supplier evaluations.
Problem Solving: Resolve technical issues within the laboratory. Lead investigations for out-of-specification results and deviations, and implement continuous improvement initiatives to optimize raw material testing and release processes.
Team Leadership: Train laboratory personnel on raw material and consumable test methods to ensure competency and compliance.
Documentation: Author and maintain raw material-related procedures, specifications, risk assessments, protocols, and summary reports. Oversee all QMS documents related to raw materials, including change controls.
Data Management: Manage raw material and consumable testing data, ensuring it is accurately stored, securely maintained, and easily retrievable. Analyze data to identify trends and areas for improvement.
Client and Audit Management: Serve as the subject matter expert for raw materials and consumables during regulatory and client audits for GMP compliance.

Qualifications

Education: A BSc or higher in Chemistry, Industrial Engineering, or a related field is required. Advanced degrees or additional certifications in relevant fields are preferred.
Experience: 7-10 years of leadership experience in the pharmaceutical or biotechnology industries, with at least 3-5 years in a leadership role specifically focused on raw material testing and release. Significant experience in a GMP and GLP environment is essential.
Skills: Proficiency in analytical techniques such as HPLC, GC, and Mass Spectrometry (MS). Knowledge of endotoxin and sterility assurance test methods. Familiarity with quality control software such as LIMS and data analysis tools.

Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is committed to advancing biosimilar manufacturing, and we are continuously working to improve processes and patient outcomes. By joining Enzene, you'll be part of a company that values integrity, innovation, and collaboration in the pursuit of scientific excellence.

Equal Opportunity Employer
Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.

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Qc Raw Material Manager

Job Description

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