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Cmc Technical Operations Jobs (NOW HIRING)

Elektrofi

Senior Director, CMC Technical Lead

Boston, MA · On-site

$235K - $285K/yr

Join us as a Senior Director, CMC Technical Lead , and you'll be part of a culture that welcomes ... and operational plans are aligned with Elektrofi's short- and long-term goals. * Foster a ...

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 ...

Travere

Director, Technical Operations

San Diego, CA · On-site

Director, Technical Operations (Small Molecule CMC) Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we ...

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Cmc Technical Operations information

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$35.5K

$91.3K

$144.5K

How much do cmc technical operations jobs pay per year?

As of Sep 10, 2026, the average yearly pay for cmc technical operations in the United States is $91,282.00, according to ZipRecruiter salary data. Most workers in this role earn between $71,000.00 and $111,500.00 per year, depending on experience, location, and employer.

What is CMC Technical Operations?

CMC Technical Operations refers to the Chemistry, Manufacturing, and Controls (CMC) functions within pharmaceutical and biotechnology companies. This area is responsible for overseeing the development, scale-up, manufacturing, and quality control of drug products. CMC Technical Operations ensures that products are manufactured consistently, meet regulatory requirements, and maintain high quality throughout their lifecycle. The team often collaborates with research, regulatory, and quality assurance departments to bring safe and effective medicines to market.

What are the key skills and qualifications needed to thrive as a CMC Technical Operations professional, and why are they important?

To thrive in CMC Technical Operations, strong expertise in chemistry, manufacturing, and controls (CMC), regulatory compliance, and pharmaceutical development is essential, often supported by a degree in life sciences or engineering. Familiarity with quality management systems, process validation, and regulatory submission tools like eCTD is typically required. Excellent problem-solving, cross-functional collaboration, and project management skills help professionals excel in this role. These abilities are critical for ensuring product quality, regulatory approval, and efficient progression from development through commercial manufacturing.

What are some common challenges faced by professionals in CMC Technical Operations, and how can they be overcome?

Professionals in CMC (Chemistry, Manufacturing, and Controls) Technical Operations often encounter challenges such as managing complex regulatory requirements, coordinating cross-functional teams, and ensuring seamless technology transfer from development to manufacturing. Staying organized and maintaining clear communication with regulatory, quality, and manufacturing groups is crucial. Proactively identifying potential bottlenecks and maintaining flexibility can help address unforeseen technical issues, ultimately supporting timely product commercialization.

What is the difference between Cmc Technical Operations vs CMC Regulatory Affairs?

AspectCmc Technical OperationsCMC Regulatory Affairs
Required CredentialsBachelor's in Chemistry, Pharmaceutical Sciences, or related field; technical certificationsBachelor's or higher in Life Sciences, Regulatory Affairs, or related; certifications like RAC
Work EnvironmentLaboratories, manufacturing facilities, technical teamsRegulatory agencies, corporate offices, compliance teams
Employer & Industry UsagePharmaceutical manufacturing, biotech companiesPharmaceutical companies, regulatory agencies
Common Search & ComparisonYesYes

While Cmc Technical Operations focuses on manufacturing processes, technical troubleshooting, and product development, CMC Regulatory Affairs handles regulatory submissions, compliance, and communication with authorities. Both roles are essential in the pharmaceutical industry but serve different functions within the product lifecycle.

What are popular job titles for Cmc Technical Operations?

Popular job titles for Cmc Technical Operations:

Infographic showing various Cmc Technical Operations job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $91,282 per year, or $43.9 per hour.

Associate Director, Regulatory Affairs - CMC

Warren, NJ • On-site

PTC Therapeutics
Manufacturing • 501 - 1,000 employees
Learn more about PTC Therapeuticsexternal

Full-time

Medical, Dental, Vision, Retirement

Re-posted 18 days ago

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
Visit our website to learn more about our company and culture!
Site: www.ptcbio.com
Job Description Summary:
The Associate Director, Regulatory Affairs - CMC will be responsible for leading global regulatory CMC strategy for product development and registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) according to global regulatory expectations and requirements.
This position works cross-functionally with Regulatory Affairs, Technical Operations, and Quality to facilitate the completion of regulatory filing documentation in accordance with company timelines.
This position ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:
Responsibilities:
  • Leads and manages the development and preparation of CMC-related submission documents for small molecule products in collaboration with Technical Operations, Quality, and Regulatory Affairs to ensure they are organized, logical, and meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle. The submissions include, but not limited to, new drug marketing applications (eg NDA, MAA, NDS, etc), electronic Common Technical Documents (eCTDs), investigational new drug applications (eg INDs, CTAs), briefing documents, response to queries, Orphan Drug Applications, and annual reports.
  • Leads global post-approval CMC regulatory strategy for commercial products, providing CMC regulatory leadership for lifecycle changes (e.g., manufacturing site changes, scale-up/tech transfer, process improvements, control strategy updates, and analytical method changes) to ensure supply continuity and align data packages to regional requirements.
  • Collaborates with Regulatory Affairs Team to develop robust global regulatory CMC strategy and risk mitigation to enable successful regulatory submissions and approvals for drug development and registration.
  • Manage or assist with regulatory agency interactions.
  • Effectively interprets and applies regulatory guidance. Provides regulatory guidance, recommendations and solutions to cross functional teams and key stakeholders.
  • Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review, and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality.
  • Supports best practice for regulatory CMC compliance activities including, but not limited to, change controls, post-marketing commitments, product complaints, and regulatory inspections.
  • Remains current on CMC regulatory intelligence including guidelines and compendial requirements

Qualifications:
Bachelor's degree in scientific discipline. A minimum of 7-8 years Regulatory Affairs experience and/or CMC technical writing experience in a pharmaceutical, biotechnology or related environment. Advanced degree a plus.
  • Technical knowledge in small molecules with experience in translating to a regulatory document
  • Demonstrated, hands-on experience in pharmaceutical development, registration, and post-approval life cycle management in a global environment.
  • Prior experience within a GMP environment with a firm understanding of industry regulations and best practices
  • Excellent working knowledge of the ICH region regulations for small molecule drugs.
  • Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, NDS, briefing documents, and response to agency queries.
  • Ability to influence without direct authority.
  • Demonstrated excellent collaboration skills.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Proficiency with Microsoft Office.
  • Advance academic degree (Masters or PhD).
  • Regulatory experience in non-CMC related matters.
  • Regulatory experience in supporting development and registration in ex-ICH regions

Travel requirements- Up to 10% travel
Expected Base Salary Range:
$169,100 - $212,800. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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