ZipRecruiter

Log In

1

Director Cmc Technical Operations Jobs (NOW HIRING)

Travere

Senior Project Manager, Technical Operations

$113K - $155K/yr

Department: 106800 Technical Operations Location: San Diego, USA- Remote Be a part of a global team ... Direct experience supporting biologic drug products, including CMC development, manufacturing, and ...

WhiteCap Search

CMC Project Manager

Cambridge, MA · On-site

This role will coordinate cross-functional activities across technical, operational, and business ... Experience supporting CMC or technical operations programs. * Experience within biologics, advanced ...

Travere

Director, Technical Operations

The Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at Travere CDMOs. Serving as a key ...

Travere

Director, Technical Operations

San Diego, CA · On-site

The Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API development and manufacturing activities conducted at Travere CDMOs. Serving as a key ...

BrainChild Bio

Director, CMC Quality

$190K - $210K/yr

QC Operations Oversight * Provide strategic Quality oversight for QC support activities performed ... Proven ability to manage competing priorities, lead complex technical quality initiatives, and make ...

previous pagenext page

Showing results 21-40

All JobsCmc Technical Operations JobsDirector Cmc Technical Operations Jobs

Director Cmc Technical Operations information

See salary details

$26K

$115.5K

$232K

How much do director cmc technical operations jobs pay per year?

As of Sep 8, 2026, the average yearly pay for director cmc technical operations in the United States is $115,510.00, according to ZipRecruiter salary data. Most workers in this role earn between $68,000.00 and $154,500.00 per year, depending on experience, location, and employer.

What are popular job titles related to Director Cmc Technical Operations jobs?

For Director Cmc Technical Operations jobs, the most frequently searched job titles are:

Infographic showing various Director Cmc Technical Operations job openings in the United States as of June 2026, with employment types broken down into 94% Full Time, 5% Part Time, and 1% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $115,510 per year, or $55.5 per hour.

Director CMC Regulatory

South San Francisco, CA • On-site

Corvus Pharmaceuticals, Inc.
Biotechnology Research and Development • 11 - 50 employees
Learn more about Corvus Pharmaceuticals, Inc.external

$200 - $250/hr

Other

Posted 10 days ago

Job description

Department/Group: Regulatory Affairs
Location: South San Francisco, CA
Position Type: Full time

Position Overview:

Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer. Our lead program, soquelitinib, is a first-in-class, oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system.

Reporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for clinical-stage small molecule programs. This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.

Key Responsibilities:
  • Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through NDA/MAA and lifecycle management)
  • Provide strategic input and regulatory guidance on manufacturing changes, comparability approaches, and control strategies
  • Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (e.g. FDA, EMA, Health Canada, PMDA)
  • Lead preparation and authorship of CMC sections (Module 2.3, 3) for: INDs/CTAs/Amendments
  • Lead preparation of CMC Briefing documents and health authority interactions
  • NDA/MAA and supplements/variations preparation and submissions
  • Ensure alignment of CMC documentation with overall regulatory strategy and program timelines
  • Oversee document quality, consistency, and compliance with global regulatory requirements
  • Represent regulatory in change control assessments
  • Support inspection readiness activities in collaboration with Quality and Manufacturing teams
Qualifications
  • Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred
  • Minimum of 10+ years of regulatory affairs experience in biotech/pharma
Preferred Skills:
  • Experience supporting small molecules required (familiarity with additional modalities desirable).
  • Experience with IND/CTA, NDA/MAA compilation and submissions.
  • Deep knowledge of CMC development for small molecules, Module 3 structure and expectations, and comparability and change management strategies.
  • Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)
  • Proven ability to operate effectively in a small, fast-paced biotech environment
  • Strong cross-functional leadership and influencing skills without direct authority
  • Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies
#J-18808-Ljbffr

Apply