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Cmc Biologics Jobs (NOW HIRING)

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Director/ Senior Director, Regulatory CMC

Boston, MA · On-site

$163K - $215K/yr

Extensive experience in the development of biologics and combination biologic/device products is a must. Key areas of responsibility: • As a member of the CMC project teams, act as Regulatory CMC ...

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Cmc Biologics information

What is a 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 skills and qualifications are needed to thrive as a CMC Biologics professional?

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 are 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 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.

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Cmc Biologics jobs near you
Infographic showing various Cmc Biologics job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 91% Full Time, 3% Part Time, 1% Temporary, and 4% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution.

Senior Scientist 1, Bioassay Development, CMC Biologics, Analytical Research & Development

AbbVie

South San Francisco, CA • On-site

$143K - $162K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 16 days ago

AbbVie rating

8.7

Company rating: 8.7 out of 10

Based on 103 frontline employees who took The Breakroom Quiz

14th of 86 rated pharmaceutical

Job description

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Senior Scientist 1, Bioassay Development, CMC Biologics, Analytical Research & Development, AbbVie Biotherapeutics Inc., South San Francisco, CA: Onsite (onsite 5 days per week).
Key Responsibilities
  • Develop & optimize complex bioassays & target-binding potency assays critical for development of complex biotherapeutics.
  • Collaborate with analytical teams to elucidate structure/function & interact cross-functionally with teams from Discovery, Chemistry Manufacturing & Controls (CMC), QC, QA to support drug development activities & IND submissions.
  • Qualify/validate/transfer potency methods to external partners & author technical documents (e.g. test methods, protocols, & reports) to enable regulatory submissions).
  • Develop new techniques, explore new approaches & technologies, perform troubleshooting & optimization experiments, & present your work to various cross-functional teams.

Qualifications
Education & Experience
Must possess a MS degree in biology, biochemistry, cell/molecular biology, or a related field & 1 year of academic research experience or industry work as a development scientist.
Of academic research experience &/or industry work experience required, must have 1 year:
  1. developing binding potency assays (ELISA, TR-FRET, Octet, flow cytometry, other cell-based formats) to characterize & test protein therapeutics (monoclonal antibodies, ADCs, &/or other biologic modalities);
  2. developing cell-based functional potency assays (cytotoxicity assays, reporter gene assays, proliferation assays, effector function activity assays (i.e. ADCC, CDC) to characterize & test protein therapeutics (monoclonal antibodies, ADCs, &/or other biologic modalities);
  3. performing cell-based target binding potency assays, noncell-based target binding potency assays, &/or functional potency assays to characterize drug mechanism of action;
  4. using GraphPad PRISM, PLA, Softmax Pro, or similar data analysis software;
  5. optimizing & troubleshooting potency assays to improve performance &/or resolve performance issues;
  6. working in a matrixed organization within a crossfunctional scientific environment within a (CMC) organization; &
  7. authoring technical reports, drafting SOPs, writing CMC sections of regulatory filings, & giving scientific presentations to peers & management.

Alternatively, would accept BS Degree in biology, biochemistry, cell/molecular biology, or a related field & 5 years academic research experience &/or industry work experience required as a development scientist.
Of work experience required, must have 5 years of academic research experience &/or industry work experience in each of (i) (ii), (iii), (iv), (v), (vi) & (vii).
Work experience may be gained concurrently. Will accept combination of education, training & work experience.
Additional Information
Salary Range: $143,067.06 - $162,000.00 per year.
Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID: REF49886M
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html

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About AbbVie

Sourced by ZipRecruiter

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

Industry

Scientific research and development services

Company size

10,000+ Employees

Headquarters location

North Chicago, IL, US

Year founded

2013

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