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Cmc In Biotech information

How is CMC used in pharmaceuticals?

In the context of CMC (Chemistry, Manufacturing, and Controls) in biotech jobs, CMC involves developing and controlling the processes for producing pharmaceuticals, ensuring product quality, safety, and efficacy. It includes activities like formulation development, process validation, and stability testing, often requiring knowledge of regulatory requirements and laboratory skills.

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?

In biotech, CMC stands for Chemistry, Manufacturing, and Controls, which refers to the detailed documentation and processes involved in developing and producing a pharmaceutical product. CMC professionals ensure that drugs are manufactured consistently, meet quality standards, and comply with regulatory requirements, often working with laboratory techniques, quality assurance, and regulatory submissions.

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 in research and development environments.

What are CMC jobs?

CMC jobs in biotech refer to roles involved in Chemistry, Manufacturing, and Controls activities, which ensure the quality, safety, and efficacy of biopharmaceutical products. These positions often require knowledge of regulatory requirements, laboratory skills, and experience with process development and validation. CMC professionals play a critical role in drug development and manufacturing compliance.
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Cmc In Biotech jobs near you
Infographic showing various Cmc In Biotech job openings in Indiana as of July 2026, with employment types broken down into 33% Locum Tenens, 1% As Needed, 55% Full Time, 5% Part Time, 4% Contract, and 2% Summer. Highlights an 84% Physical, 3% Hybrid, and 13% Remote job distribution.
Scientist, Pharmacology and Toxicology

Scientist, Pharmacology and Toxicology

MBX Biosciences

Carmel, IN • On-site

Full-time

Posted 19 days ago

Job description

Position Summary
The Scientist, Pharmacology and Toxicology, reporting to the Sr. Director of Pharmacology & Toxicology is an individual contributor who works in a team environment (toxicology, pharmacology, medical/clinical, regulatory, CMC) in biotech drug discovery and development. The position includes study design and monitoring, development of relationships with toxicology CROs and university discovery pharmacology activities, data review, data interpretation, and data presentations. This includes exploratory studies and GLP studies to support regulatory filings. In addition, the role will liaise with discovery and development colleagues and participate in development of the overall toxicology and pharmacology strategies. The role will contribute strategically to the development of assets including presenting these strategies to the asset development team as needed to ensure alignment. This role will also work with external partners such as CROs to conduct the necessary studies to support drug development and to monitor study progress.
Key Responsibilities
  • Support the conduct of preclinical toxicology programs for small and large molecules in discovery and development stages.
  • Propose and support the development of preclinical toxicology strategies to advance programs.
  • Interface with internal stakeholders in discovery and development.
  • Interface with MBX regulatory affairs on documents for FDA and other regulatory bodies.
  • Work with the clinical group to develop nonclinical timelines, and risk-benefit approaches for molecules selected to move forward to FIH trials.
  • Establish collaborations with CROs and/or academic institutions supporting MBX drug development programs.
  • Provide tactical support for multiple project teams as they advance molecules from target discovery through lead optimization to clinical development.
  • Support writing of toxicology and pharmacology sections of regulatory documents, including but not limited to the IND, IB and BLA.
  • Other duties as assigned.

Education & Qualifications
  • B.S., M.S., or PhD in Toxicology, Pharmacology, or related sciences.
  • Minimum of 5 years of related experience in biopharma or a CRO.
  • Excellent communication and interpersonal skills, with the ability to effectively influence opinion and actions.
  • Communicate strategies, plans, results, and analyses.
  • Study directing or monitoring experience in the CRO environment.
  • Demonstrated scientific excellence in the application of toxicology and pharmacology principles across pharmaceutical research and development.
  • Knowledge of U.S. and International safety guidelines and requirements for pharmaceutical development.
  • Ability to think strategically and to provide clear direction and expectations to other team members in a highly dynamic environment.
  • Strong ability to prioritize daily work based on changing business requirements.
  • Self-motivated, independent, and results oriented.
  • Ability to work productively in a matrix environment, as a team contributor supporting multiple projects.

Travel
This role is expected to be on site 3 days per week. You will be expected to travel periodically based on the needs of the business to the extent requested by the Company, including attendance at Together Weeks, Together Days, and functional meetings as requested by the Company.
Company Overview:
MBX Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company's pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism preparing for Phase 3 development; and an obesity portfolio that includes MBX 4291 in Phase 1 development and MBX 5765 in preclinical development, as well as additional discovery candidates. The Company is based in Carmel, Indiana and Burlington, Massachusetts. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
EEO Statement:
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.

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