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Cmc In Biotech Jobs in Camden, NJ (NOW HIRING)

Legend Biotech US

Sr. Scientist, Toxicology

Philadelphia, PA · Hybrid

$92K - $126K/yr

... in Somerset, NJ or Philadelphia, PA . Role Overview Legend Biotech is seeking a Sr. Scientist ... Partner closely with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams ...

Legend Biotech US

Sr. Scientist, Toxicology

Philadelphia, PA · On-site

$92K - $126K/yr

Partner closely with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams ... Minimum of 5 years of experience in nonclinical toxicology or a related field within biotechnology ...

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All JobsCmc In Biotech JobsCmc In Biotech Jobs in Camden, NJ

Cmc In Biotech information

What is the difference between Cmc In Biotech vs Formulation Scientist?

AspectCmc In BiotechFormulation Scientist
Required CredentialsBachelor's or Master's in Life Sciences, Good Manufacturing Practice (GMP) knowledgeBachelor's or Master's in Pharmacy, Chemistry, or related field; GMP experience
Work EnvironmentLaboratories, manufacturing facilities, regulatory settingsLaboratories, R&D departments, manufacturing units
Employer & Industry UsageBiotech companies, pharmaceutical firms, contract manufacturing organizationsPharmaceutical companies, biotech firms, contract labs

While both roles operate within the biotech and pharmaceutical industries, Cmc In Biotech focuses on Chemistry, Manufacturing, and Controls documentation and regulatory compliance, whereas Formulation Scientists primarily develop and optimize drug formulations. Cmc In Biotech professionals ensure regulatory submissions are complete, while Formulation Scientists work on creating effective drug delivery systems. Both roles often collaborate but serve distinct functions within the product development pipeline.

What is a CMC in biotech position?

A CMC (Chemistry, Manufacturing, and Controls) position in biotech involves overseeing the development, manufacturing, and quality control of biopharmaceutical products. Professionals in this role ensure that products meet regulatory standards and are produced consistently, often requiring knowledge of GMP (Good Manufacturing Practice) and regulatory guidelines.

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 CMC in biotech?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes ensuring the quality, safety, and efficacy of a biotech product throughout development and production. Professionals in this field often work on regulatory submissions, quality assurance, and process validation to meet industry standards.

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Cmc In Biotech jobs near you
Infographic showing various Cmc In Biotech job openings in Camden, NJ as of August 2026, with employment types broken down into 1% As Needed, 90% Full Time, 4% Part Time, and 5% Contract. Highlights an 79% Physical, 4% Hybrid, and 17% Remote job distribution.

Associate Director, Regulatory Affairs, CMC

Philadelphia, PA • On-site

Alnylam Pharmaceuticals
Biotechnology Research and Development • 1 - 5K employees
Learn more about Alnylam Pharmaceuticalsexternal

$170K - $231K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 22 days ago

Job description

Overview
The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic modalities, with an emphasis on oligonucleotide-based therapeutics, including siRNA, antibody drug conjugates, and next-generation delivery systems.
This role serves as a key bridge between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences, helping to translate evolving science into effective global regulatory CMC strategies. The Associate Director will bring a broad scientific foundation in biologics and/or complex modalities, along with strong communication, collaboration, and project management skills. This individual will play an important role in evaluating the regulatory implications of novel technologies and guiding development teams through an evolving global regulatory landscape.
This position is hybrid and primarily located in our Cambridge, MA or Philadelphia, PA office.
Key Responsibilities
  • Lead the development and execution of global CMC regulatory strategies for innovative small molecules, biologics, and complex modalities across early- and late-stage development.
  • Plan, review, and prepare CMC documentation for clinical trial applications, marketing authorization applications, and health authority briefing packages.
  • Lead or help to lead the interpretation of regulatory expectations for emerging modalities, including oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic or hybrid modalities.
  • Serve as a strategic interface between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences.
  • Provide strategic guidance on product characterization, control strategies, comparability approaches, and regulatory classification considerations.
  • Represent Regulatory Affairs CMC in cross-functional governance, development, and portfolio discussions.
  • Partner with technical teams to identify regulatory risks and develop proactive mitigation strategies.
  • Contribute to regulatory intelligence activities and interpretation of evolving policy for novel modalities.
  • Help build Regulatory Affairs CMC infrastructure, processes, and organizational capability.

Qualifications
  • Advanced degree in chemistry, biochemistry, pharmaceutical sciences, molecular biology, or related discipline.
  • Demonstrated experience supporting therapeutic products through multiple stages of development.
  • Minimum 8-10 years of industry experience in the pharmaceutical/biotechnology industry, including at least 5 years of Regulatory Affairs CMC experience.
  • Ability to interpret complex technical, nonclinical, clinical, and manufacturing information and translate it into clear regulatory strategies.
  • Experience with regulatory submissions and health authority interactions for development-stage programs.
  • Strong communication, collaboration, and cross-functional leadership skills.
    • Ability to evaluate emerging technologies and apply sound regulatory judgment in a fast-paced, evolving environment.
    • Strong ability to integrate scientific, technical, and regulatory considerations into clear actionable strategies.

U.S. Pay Range
$170,900.00 - $231,300.00
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
About Alnylam
We are the leader in RNAi therapeutics - a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

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