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Cmc Contract Jobs (NOW HIRING)

Argenx

Director, Regulatory CMC Device Leader

Boston, MA

$163K - $215.10K/yr

... contract manufacturers and development partners, consultants etc.) to ensure Reg CMC alignment and to integrate the global device strategy into submissions * Ensures goals are met, processes are ...

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Cmc Contract information

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$17

$26

$49

How much do cmc contract jobs pay per hour?

As of May 30, 2026, the average hourly pay for cmc contract in the United States is $26.18, according to ZipRecruiter salary data. Most workers in this role earn between $20.19 and $28.61 per hour, depending on experience, location, and employer.

What is the difference between Cmc Contract vs Cmc Coordinator?

AspectCmc ContractCmc Coordinator
Required CredentialsTypically requires a degree in life sciences or related field, with experience in contract managementUsually requires a degree in life sciences, with some experience in project coordination or administration
Work EnvironmentWorks primarily in legal, regulatory, or contract management departments within biotech or pharma companiesWorks in project teams, supporting CMC activities in pharmaceutical or biotech settings
Employer & Industry UsageCommonly employed in pharmaceutical, biotech, and contract research organizationsFound in similar industries, often supporting CMC teams in drug development

The main difference is that a Cmc Contract focuses on managing and negotiating contracts related to CMC activities, while a Cmc Coordinator handles the coordination and administrative support within CMC projects. Both roles require familiarity with CMC processes, but their responsibilities and focus areas differ.

More about Cmc Contract jobs
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What are the most commonly searched types of Cmc jobs? The most popular types of Cmc jobs are:
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What job categories do people searching Cmc Contract jobs look for? The top searched job categories for Cmc Contract jobs are:
Cmc Contract jobs near you
Infographic showing various Cmc Contract job openings in the United States as of May 2026, with employment types broken down into 67% As Needed, and 33% Full Time. Highlights an 6% Physical, and 94% Remote job distribution, with an average salary of $54,445 per year, or $26.2 per hour.

Senior Consultant, CMC Development and Manufacturing

BreezeBio

South San Francisco, CA

Part-time

Posted 15 days ago

Job description

BreezeBio is a rapidly-growing, early-stage company that is developing a proprietary and novel delivery platform with the potential to transform genetic medicine. Our interdisciplinary team works together across chemistry, payload design, formulation, and screening and preclinical groups to develop the next generation of gene therapies. BreezeBio fosters an exciting and dynamic environment where we value impactful data and creative solutions to accelerate our progression from a platform technology to a pipeline of therapeutic candidates. We are seeking talented and motivated individuals to join our team and are expanding across all functions within the organization. Join us in South San Francisco, CA, to be at the forefront of the future of gene therapy.
 
Senior Consultant, CMC Development and Manufacturing
 
 
BreezeBio is looking for an individual who will provide technical and organizational leadership and work closely with cross-functional stakeholders to ensure CMC activities are executed seamlessly and in alignment with the integrated product development plan and program timelines. The individual will lead the management of manufacturing of established drug substances and drug products for late-phase clinical trials and the development of new products. The individual will also contribute to the overall CMC strategy, planning, and execution; provide regulatory documentation for all phases of clinical trials and commercialization; and play a role in CDMO management for other CMC areas including analytical and drug product.
 The senior consultant will be a contributing member of the R&D management team to plan and execute on company objectives and R&D strategy for all programs. This person must be a strong scientist with a sound track record of technical expertise and organizational leadership, early and late stage CMC.and a knowledge of the drug discovery process from exploratory research to IND submission. This person must be able to guide and drive project teams to make decisions and recommendations to the executive team, is a critical and creative problem solver, and comfortable in a dynamic, start-up environment to find solutions to scientific, technical, and resource allocation issues to move programs forward. The ideal candidate will be a team player with excellent communications skills and work collaboratively across all functions within the company and with external partners.
 
Responsibilities
·Key polymer synthesis and development and manufacturing operations to maintain and advance company pipeline.
·Manage and maintain project timelines for CMC activities in support of early and late-phase clinical trials, ensuring strategy and roadmaps align with and feed into company goals and project timelines.
·Manage in-house CMC personnel and external subject matter experts.
·Lead CDMO and other vendor identification, assessment, qualification, and management with adequate risk assessment.
·Manage tech transfer, process familiarization, and manufacturing at CDMOs to ensure timely delivery of GMP drug substance and drug product.
·Contract and Quality Agreement negotiation.
·Develop and carry-out a QBD approach to identify CPPs in support of CQAs for efficacy and safety of drug substance.
·Author/review/approve the relevant CMC sections to enable global regulatory filings.
·Generate, review, and/or approve study protocols, development reports, and manufacturing batch records.
·Manage developmental stage-appropriate analytical activities.
·Communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making.
·Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, quality, IP) to ensure CMC and program goals are met.
 
Education and Qualifications:
·PhD in polymer chemistry or polymer science and engineering with industry experience in synthesis scale-up and downstream processing, ideally in a therapeutic drug context.
-10+ years in industry CMC; 3+ years of experience as CMC team leader, managing team members and projects.
·Proven success in vendor management, specifically CDMOs, with track record of negotiating contracts and completion of projects on time and within budget.
·Successful management of CDMO to manufacture GMP product for late-phase clinical trials is a requirement.
·Thorough understanding and working experience in drug substance development and manufacturing with respect to quality by design, GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Experience writing CMC section of NDA is a plus.
·Experience with key analytical techniques: NMR, GPC-RI, HPLC, UV-vis, fluorescence spectroscopy, DSC, ITC,  MAL-SEC, and other characterization methods.
·Highly motivated scientist with particular attention to detail and the ability to independently plan, design and implement experiments
·Excellent written, verbal and presentation skills
·Work authorization in the US is required
 
At BreezeBio we are always looking to hire the absolute best talent and recognize that diversity in our experiences and backgrounds is what makes us stronger. We hire candidates of any race, color, ancestry, religion, sex, national origin, sexual orientation, gender identity, age, marital or family status, disability, veteran status, and any other status. These differences are what enable us to work towards the future we envision for ourselves, and the world.
 
 

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