Director, GMP Quality

C4 Therapeutics Inc • Watertown, MA

1d

About The Position

About C4 Therapeutics: C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases. C4T’s degrader medicines are designed to harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. For more information, please visit www.c4therapeutics.com . Job Summary In this role, you will support the Quality function at C4 Therapeutics, with a keen focus on GMP Quality Assurance. You will oversee the manufacturing and testing of clinical trial material, including quality control and other types of analytical testing, and support for the Quality System. Your work will be integral as we advance safe, effective medicines through the clinical trial process and onto potential commercialization.

Requirements

• Required: Bachelor’s degree in a scientific field with 10+ years of experience in biotech or pharma
• Full understanding of GxP regulations and regulatory compliance guidelines, including full and current knowledge of quality assurance best practices in a bio-pharmaceutical clinical environment
• Demonstrated strong GMP experience with an in-depth understanding of all aspects of technical development and manufacturing from preclinical through commercialization, including validation
• Proven leadership and managerial skills and demonstrated experience working across all functions and levels
• Direct experience successfully working with outsourced manufacturing and testing operations

Nice To Haves

• Experience with Phase 1 Manufacturing

Responsibilities

• Assure quality support and oversight for the manufacture, testing, packaging, and product disposition of clinical trial materials ensuring compliance with GxP regulations and expectations
• Assure quality support for analytical method development, testing, product specifications, and COA review
• Assure quality support for development projects including technology transfers, qualifications, and validations
• Participate in preparation of responses to regulatory agency questions
• Support and oversight of stability programs including stability protocol review and approval as well as oversight of testing
• Compilation and input of testing results and trend analysis
• Support the development and maintenance of C4T governance documents including authoring, reviewing, and/or approving policies and standard operating procedures (SOPs)
• Support the review and approval of Quality System documents including Process Change Controls, Deviations, Corrective and Preventative Actions (CAPA)
• Support the Vendor Management Program including vendor assessments and oversight of audit activities
• Support the Internal Audit Program including participation as an auditor and auditee

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees