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Cmc Biotech Jobs (NOW HIRING)

Actalent

CMC Project Coordinator

Charlestown, MA

Experience in biotech or pharmaceutical settings with exposure to CMC, quality control, or analytical development functions. * Understanding of the assay lifecycle, including development ...

Actalent

CMC Project Coordinator

Charlestown, MA

Experience in biotech or pharmaceutical settings with exposure to CMC, quality control, or analytical development functions. * Understanding of the assay lifecycle, including development ...

Meet Life Sciences

Director Regulatory Affairs CMC

Sonoma, CA · Hybrid

$168K - $221K/yr

Director, Regulatory CMC (Hybrid - San Francisco Bay Area) We are partnering with a well-funded, clinical-stage biotechnology company with a diversified pipeline spanning both biologics and small ...

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA · On-site

$161K - $213K/yr

... biotechnology companies * Demonstrated experience leading CMC sections of biologics marketing ... applications (BLA/MAA) strongly preferred * Experience in rare disease drug development preferred

Dyne Therapeutics

Director, Regulatory CMC

Waltham, MA

$161K - $213K/yr

Lead and execute global CMC regulatory strategies for assigned programs across all phases of ... in the biotech or pharmaceutical industry, with a minimum of 7 years in Regulatory Affairs ...

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How much do cmc biotech jobs pay per hour?

As of Jun 12, 2026, the average hourly pay for cmc biotech in the United States is $28.94, according to ZipRecruiter salary data. Most workers in this role earn between $21.39 and $33.41 per hour, depending on experience, location, and employer.

What jobs will no longer exist in 2030?

In 2030, roles in manual manufacturing, data entry, and routine administrative tasks are expected to decline due to automation and AI advancements. Jobs requiring repetitive tasks or basic skills may be replaced by machines or software, while roles involving complex decision-making and creativity are likely to persist.

What are CMC Biotech professionals?

CMC Biotech professionals specialize in Chemistry, Manufacturing, and Controls (CMC) within the biotechnology industry. They are responsible for developing, manufacturing, and ensuring the quality and regulatory compliance of biopharmaceutical products from early development through commercialization. Their work includes process development, scale-up, analytical testing, and creating documentation for regulatory submissions. CMC experts play a crucial role in bringing safe and effective biotech therapies to market.

What are some common challenges faced by CMC Biotech professionals when working cross-functionally with other departments?

CMC (Chemistry, Manufacturing, and Controls) Biotech professionals often collaborate closely with teams in research, quality assurance, regulatory affairs, and production. A common challenge is aligning timelines and expectations across departments, as regulatory requirements and quality standards may evolve during product development. Effective communication and proactive project management are crucial to ensure that all teams are aligned, especially when handling complex data or responding to regulatory feedback. Building strong cross-functional relationships and maintaining flexibility can help CMC professionals successfully navigate these challenges.

What are the big 4 in biotech?

The 'Big 4' in biotech typically refers to the four largest pharmaceutical and biotech companies: Johnson & Johnson, Roche, Pfizer, and Novartis. These companies lead the industry in research, development, and market share, often requiring biotech professionals to have strong knowledge of drug development, regulatory processes, and laboratory skills.

What is a CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing, producing, and ensuring the quality of a biopharmaceutical product. CMC professionals are responsible for regulatory compliance, process validation, and quality assurance to meet industry standards and facilitate product approval.

What is the highest paying job in biotech?

In biotech, senior executive roles such as Chief Scientific Officer (CSO) or Vice President of Research typically have the highest salaries, often exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and leadership skills, and they oversee research and development strategies within biotech companies.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) Biotech professional, and why are they important?

To thrive as a CMC Biotech professional, you need a strong background in biochemistry, molecular biology, regulatory affairs, and process development, often supported by an advanced degree in life sciences or chemical engineering. Familiarity with regulatory submission tools (such as eCTD), quality management systems, and analytical instrumentation is critical. Strong project management, attention to detail, and cross-functional communication skills help ensure effective collaboration and compliance. These competencies are essential for developing safe, effective biotech products while meeting stringent regulatory standards.
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Cmc Biotech jobs near you
Infographic showing various Cmc Biotech job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 74% Full Time, 3% Part Time, 21% Contract, and 1% Nights. Highlights an 82% Physical, 3% Hybrid, and 15% Remote job distribution, with an average salary of $60,196 per year, or $28.9 per hour.

CMC Project Leader

HONGENE BIOTECH CORPORATION

Cambridge, MA • On-site

$140K - $190K/yr

Full-time

Posted 25 days ago

Job description

Job Title

Associate Director / Senior Manager, CMC Project Management

Location

Boston area preferred (or ability to commute regularly)

Company Overview

Hongene Biotech is a global leader in nucleic acid manufacturing, supporting RNA therapeutics, mRNA vaccines, and molecular diagnostics. With a vertically integrated platform from raw materials to CDMO services, we enable our partners to accelerate development with efficiency and quality.

Position Overview

This role will report directly to the VP, Global Head of CMC & Regulatory and is critical in strengthening Hongene’s project management capabilities for its oligonucleotide contract manufacturing services.

Level and title will be determined based on experience. We are primarily targeting Senior Manager to Associate Director level. Exceptional candidates may be considered at Director level.

The Primary Job Responsibilities

1) Drive project management efforts associated with CMC activities to support oligonucleotide contract manufacturing projects at Hongene Biotech.

2) Support Head of CMC and Oligonucleotide team in developing and executing development and manufacturing strategy and tactical executional plans.

3) Bridge communication between Clients and the internal teams in support of multiple contract manufacturing projects for different clients, including participation in technical calls, tracking of action items and facilitating rapid decision making within the team to drive programs forward.

4) Coordination with AD/PD, manufacture, quality and BD team to build, and manage global clients’ project timelines, work with BD to generating RFP proposals and evaluate necessary resources and ensure RFP proposals are aligned with overall strategy and cost estimation. Proactively identify potential risks, resourcing constraints and conflicts that could impact project timelines; collaborate with the AD/PD, manufacturing, QA/QC teams to develop appropriate solutions.

5) Support projects with strategic partners in US.

The candidate must have strong communication skills and be capable of strategically communicating with internal and external stakeholders, as well as effectively communicating across functions and fluent speaking both English and Mandarin. Finally, the candidate must be comfortable with, and thrive in, a fast-paced entrepreneurial environment.

Minimal Requirements

• B.S or M.S in Pharmaceutical Science, Chemistry, Biochemistry, or related scientific discipline with 8+ years of applicable experience in the biotechnology or pharmaceutical industry.

• Demonstrated proficiency in the discipline of project management. Experience with operating in a GMP environment and working in cross functional environments. Demonstrated ability to exercise independent judgement and strategic thinking.

• Strong interpersonal skills and experience of managing cross-function projects.

• Ability to thrive in a fast-paced, hands-on research and development environment.

• Adept at building strong relationships and collaborating with colleagues at all levels.

• Ability to discern paths forward within ambiguous environments.

• Excellent verbal, written, and presentation skills for communication with internal and external customers is essential.

Preferred Qualifications

• Minimum of 5 years’ experience in project or program management at a biotechnology or pharmaceutical company with direct involvement in the CMC area

• Experience with project management tools (e.g. MS Project, Smartsheet, Clarizen) and collaboration tools (BOX, SharePoint, MS Teams)

• Understanding of the different phases of drug development and cGMP requirements

• Experience in small molecules, oligonucleotides, or biologic drug development

• Located in US EST time zone