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Cmc Biologics Jobs (NOW HIRING)

BeiGene, Inc.

Executive Director, Regulatory Affairs, CMC

$153K - $202K/yr

Biologics Regulatory CMC organization. This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based ...

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 ...

Allucent

Sr. Director, CMC

Cary, NC · Remote

As a Sr. Director, CMC at Allucent, you are responsible for assisting clients with Chemistry ... Experience in pre-approval products; large biologics experience required. * Line management ...

Allucent

Sr. Director, CMC

Cary, NC · On-site +1

As a Sr. Director, CMC at Allucent, you are responsible for assisting clients with Chemistry ... Experience in pre-approval products; large biologics experience required. * Line management ...

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Cmc Biologics information

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$18

$66

$116

How much do cmc biologics jobs pay per hour?

As of Jun 14, 2026, the average hourly pay for cmc biologics in the United States is $66.20, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $92.79 per hour, depending on experience, location, and employer.

What are CMC Biologics?

CMC Biologics refers to the Chemistry, Manufacturing, and Controls (CMC) processes involved in the development and production of biological drugs (biologics). CMC Biologics professionals ensure that biologic products are consistently manufactured to meet quality, safety, and efficacy standards required by regulatory agencies. This involves overseeing the formulation, production processes, quality control, and documentation needed for regulatory submissions and product approvals. They play a crucial role in bringing biologic medicines from early development through to commercial production.

What are some common challenges faced by professionals working in CMC Biologics, and how can they be addressed?

Professionals in CMC (Chemistry, Manufacturing, and Controls) Biologics often encounter challenges such as coordinating cross-functional teams, ensuring regulatory compliance, and managing complex timelines for product development. Navigating evolving regulatory requirements and implementing robust quality systems are key aspects of the role. Successful CMC Biologics professionals proactively communicate with stakeholders, stay updated with industry guidelines, and leverage project management tools to ensure alignment across development, manufacturing, and quality teams.

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

To thrive as a CMC (Chemistry, Manufacturing, and Controls) Biologics professional, you need a solid background in biochemistry, molecular biology, or chemical engineering, often supported by an advanced degree in a life science field. Familiarity with regulatory guidelines (such as FDA and EMA), quality management systems, and analytical tools like HPLC and mass spectrometry is typically required. Strong problem-solving skills, attention to detail, and effective cross-functional communication set standout professionals apart. These competencies are crucial to ensure regulatory compliance, product quality, and successful biologics development and manufacturing.

What is the difference between Cmc Biologics vs CMC Scientist?

AspectCmc BiologicsCMC Scientist
Required CredentialsBachelor's or Master's in Life Sciences, relevant industry experienceBachelor's or Master's, often with additional certifications in biologics or pharmaceutical sciences
Work EnvironmentBiologics manufacturing facilities, quality control labsResearch labs, development departments, manufacturing support
Employer & Industry UsageBiotech and pharmaceutical companies specializing in biologicsPharmaceutical companies, biotech firms, contract manufacturing organizations

The main difference is that Cmc Biologics typically refers to roles involved in biologics manufacturing and quality assurance, while CMC Scientist focuses on research, development, and process optimization of biologics. Both roles require similar educational backgrounds but differ in daily responsibilities and work settings.

More about Cmc Biologics jobs
What cities are hiring for Cmc Biologics jobs? Cities with the most Cmc Biologics job openings:
What states have the most Cmc Biologics jobs? States with the most job openings for Cmc Biologics jobs include:
What job categories do people searching Cmc Biologics jobs look for? The top searched job categories for Cmc Biologics jobs are:
Cmc Biologics jobs near you
Infographic showing various Cmc Biologics job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 94% Full Time, 3% Part Time, and 2% Contract. Highlights an 91% Physical, 4% Hybrid, and 5% Remote job distribution, with an average salary of $137,696 per year, or $66.2 per hour.

Director / Senior Director, Regulatory CMC (Biologics)

Oruka Therapeutics

Waltham, MA • Hybrid

$25K/mo

Other

Posted 5 days ago

Job description

Job Title: Director / Senior Director, Regulatory CMC (Biologics)       

Location: Hybrid - Waltham, MA Candidates will be required to be in-office 3 days/week.          

Role Overview:

We are seeking an experienced and motivated regulatory CMC leader to shape strategy and execution across early-to-late-stage biologics programs. In this role, you will own the development of high-quality regulatory CMC submissions and guide cross-functional teams on phase-appropriate global regulatory expectations. You are an ideal candidate if you bring deep expertise in biologics development and manufacturing, including strong experience with drug substance and drug product CMC submissions. You will have the opportunity to influence program strategy, foster collaboration across CMC, QA, RA, Supply Chain, and external partners, and drive key decisions that support multiple programs in our rapidly growing biologics pipeline. This is a highly visible role where you will be responsible for submissions that are aligned with FDA, EMA, ICH, and WHO guidelines while supporting corporate and program level objectives.

Key Responsibilities: 

  • Own and drive global regulatory CMC strategy for drug substance and drug product across all stages (IND through BLA)
  • Lead development of high-quality CMC dossiers, timelines, and submission strategies for global filings
  • Serve as the CMC regulatory SME on program teams, influencing cross-functional decisions and overall development strategy
  • Collaborate with CMC, Supply chain, QA and RA functions to support maintenance of product compliance, shelf life, and change control procedures
  • Lead cross-functional coordination to plan and deliver timely, high-quality responses to CMC regulatory information requests
  • Ensure all submissions meet phase-appropriate expectations and align with FDA, HC, EMA, ICH, and WHO guidelines
  • Anticipate regulatory risks and proactively develop mitigation strategies to keep programs on track
  • Collaborate effectively with internal teams and external partners including CDMOs to generate high quality source documents
  • Guide late-stage development planning, including process characterization, PPQ, and readiness for commercial filings
  • Bring a clear, proactive, solution-oriented mindset with the attitude to manage competing priorities
  • Thrive in a fast-paced biotech environment where agility and accountability matter
  • Contribute to a culture of collaboration, transparency, and continuous improvement

Qualifications:

  • MS or PhD in life sciences with 10+ years of experience in a biologics focused CMC role and a minimum of 5+ years of direct regulatory CMC experience
  • Strong command of cGMPs, biologics development (manufacturing, release, stability) and associated global regulatory expectations. Experience with drug device combinations (e.g., prefilled syringes, auto injectors) is preferred
  • Proven track record of leading global CMC submissions and preparing briefings for milestone interactions with global health authorities (FDA, EMA etc.)
  • Broad experience across development stages from early development through late stage and commercialization; Hands-on experience with BLA CMC submission is ideal
  • Working knowledge of drug substance and drug product CMC development, including process, analytical development, QC, and shelf-life strategy
  • Demonstrated ability to operate strategically while staying close to overall regulatory planning and execution
  • Experience building alignment across teams (CMC, QA, Supply chain, QA, RA and PM) in a fast-paced biotech environment
  • Strong scientific and communication skills with operational experience in tracking multiple activities, deliverables, and timelines

Compensation:

  • An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
  • The anticipated salary range for candidates, who will work in Waltham, MA, is $213,000-240,000 for Director and $255,00-286,000 for Senior Director. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Apply