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Cmc Small Molecules information

What is CMC Small Molecules?

CMC Small Molecules refers to the Chemistry, Manufacturing, and Controls (CMC) activities involved in the development and production of small molecule drugs. These are low molecular weight compounds, typically developed as medicines for a wide range of diseases. CMC encompasses the processes for ensuring that these drugs are manufactured consistently, safely, and to high-quality standards, including formulation, testing, stability, and compliance with regulatory guidelines. Professionals working in CMC Small Molecules are critical to bringing new pharmaceutical products from the laboratory to the market.

What skills and qualifications are needed to thrive as a CMC Small Molecules professional?

To thrive as a CMC Small Molecules professional, you need a strong background in chemistry, pharmaceutical sciences, and regulatory guidelines, usually supported by an advanced degree in a scientific discipline. Familiarity with analytical instrumentation, GMP manufacturing processes, and regulatory submission systems (such as eCTD) is crucial. Strong project management, problem-solving abilities, and effective cross-functional communication help individuals excel in this field. These skills ensure the successful development, scale-up, and regulatory approval of safe and effective small molecule pharmaceuticals.

What are the main challenges faced by CMC Small Molecules professionals during drug development projects?

CMC Small Molecules professionals often encounter challenges such as ensuring consistent product quality across different manufacturing scales, meeting strict regulatory requirements, and managing tight project timelines. Collaboration with cross-functional teams—including analytical, formulation, and regulatory groups—is essential for aligning on specifications and resolving technical issues. Staying adaptable and detail-oriented helps address unexpected process or analytical hurdles, which are common in the development and scale-up of small molecule therapeutics.

What is the difference between Cmc Small Molecules vs CMC Formulation Scientist?

AspectCmc Small MoleculesCMC Formulation Scientist
Required CredentialsBachelor's or Master's in Chemistry, Pharmaceutical Sciences, or related fields; GMP knowledgeBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields; formulation expertise
Work EnvironmentLaboratories, manufacturing facilities, R&D settingsLaboratories, formulation development labs, production environments
Employer & Industry UsagePharmaceutical companies, biotech firms, contract research organizationsPharmaceutical companies, biotech firms, contract manufacturing organizations

While both roles involve working within the pharmaceutical industry and require similar educational backgrounds, Cmc Small Molecules focuses on the development and manufacturing of small molecule drugs, emphasizing chemistry and process development. In contrast, CMC Formulation Scientists specialize in creating drug formulations, ensuring stability and delivery. Both roles are essential in bringing new drugs to market but differ in their specific focus areas and daily responsibilities.

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For Cmc Small Molecules jobs in Indiana, the most frequently searched job titles are:

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The top searched job categories for Cmc Small Molecules jobs in Indiana are:

What cities in Indiana are hiring for Cmc Small Molecules jobs?

Cities in Indiana with the most Cmc Small Molecules job openings:

Cmc Small Molecules jobs near you
Infographic showing various Cmc Small Molecules job openings in Indiana as of August 2026, with employment types broken down into 80% Full Time, 16% Part Time, and 4% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Scientist, Pharmacology and Toxicology Carmel, Indiana or Burlington, MA

MBX Biosciences, Inc.

Carmel, IN • On-site

$120 - $180/hr

Other

Posted 3 days ago

New

Job description

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 during 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.

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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