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Cmc Small Molecules Jobs (NOW HIRING)

Director Regulatory Affairs CMC

Sonoma, CA · Hybrid

$168K - $221K/yr

The Director, Regulatory CMC will lead global CMC regulatory strategy and execution across multiple programs, including biologics and small molecules. This individual will serve as a key interface ...

The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical ...

The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical ...

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Cmc Small Molecules information

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How much do cmc small molecules jobs pay per hour?

As of Jun 12, 2026, the average hourly pay for cmc small molecules in the United States is $26.19, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $33.65 per hour, depending on experience, location, and employer.

What is a CMC job?

A CMC (Chemistry, Manufacturing, and Controls) job involves developing, manufacturing, and ensuring the quality of small molecule drugs. Professionals in this role typically work in pharmaceutical or biotech companies, focusing on regulatory compliance, process development, and documentation to support drug approval and production.

What are 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 is the difference between GMP and CMC?

In the context of CMC Small Molecules, GMP (Good Manufacturing Practice) refers to the regulations ensuring quality and safety during manufacturing, while CMC (Chemistry, Manufacturing, and Controls) encompasses the comprehensive documentation and processes involved in drug development and production. CMC includes activities like process development, quality control, and stability testing, all of which must comply with GMP standards to ensure product consistency and safety.

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.

What are the key skills and qualifications needed to thrive as a CMC (Chemistry, Manufacturing, and Controls) Small Molecules professional, and why are they important?

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 CMC activities in pharma?

CMC activities in pharma refer to Chemistry, Manufacturing, and Controls processes involved in the development and production of small molecules. These activities include formulation development, process optimization, quality control, stability testing, and regulatory documentation to ensure product safety and efficacy. Professionals in this field often work with laboratory techniques, regulatory standards, and manufacturing protocols to support drug approval and commercialization.

What are some of 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 CMC in eCTD?

In the context of CMC Small Molecules, CMC refers to Chemistry, Manufacturing, and Controls, which are sections of the eCTD (electronic Common Technical Document) that provide detailed information on the drug's composition, manufacturing processes, quality control, and stability. These sections are essential for regulatory submissions to demonstrate product consistency and safety. Professionals in this field need to ensure accurate documentation and compliance with regulatory standards during the drug approval process.
More about Cmc Small Molecules jobs
What cities are hiring for Cmc Small Molecules jobs? Cities with the most Cmc Small Molecules job openings:
What states have the most Cmc Small Molecules jobs? States with the most job openings for Cmc Small Molecules jobs include:
Infographic showing various Cmc Small Molecules job openings in the United States as of June 2026, with employment types broken down into 85% Full Time, and 15% Part Time. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $54,467 per year, or $26.2 per hour.

CMC Lead, Launch Product, Small Molecules

Takeda

Cambridge, MA • On-site

Full-time

Posted 18 days ago


Job description

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job DescriptionTitle: CMC Lead, Launch Product, Small Molecules Location: Zurich, Switzerland (Primary)Location: Cambridge, MA (Secondary)About the role:

As a CMC Lead, Launch Product, Small Molecules, you will provide strategic and operational leadership for the CMC execution and lifecycle management of a key launched product within Takeda's small molecule portfolio. You will serve as the CMC Leader and primary interface between Pharmaceutical Sciences, Global Supply & Quality (GSQ), and manufacturing technology organizations, ensuring scientific excellence, robust lifecycle stewardship, and optimal resource utilization across competing priorities. You will build, develop, motivate and lead a global team of experts responsible for CMC content of a key launched product within the Takeda's small molecule portfolio, You will also provide strong direction in prioritization of life cycle management and technology excellence activities to optimize resource utilization given competing requirements for key development small molecule program.

How will you contribute:
  • Lead the cross functional GSQ CMC team to support effective product development activities with Pharmaceutical Sciences Organization.

  • Lead the GSQ CMC team to develop a robust life cycle management for Takeda's key small molecule assets.

  • Represent CMC matters within Takeda's Global Product Teams.

  • Provide strong leadership for initiatives which are complex or span across multiple products.

  • Accountable for the scientific/CMC contents related to a SM asset, take into consideration of business impact to the GSQ organization.

  • Ability to lead the Small Molecules CMC team to effectively resolve issues relating to CMC matter, also at times with the Pharmaceutical Sciences organization, when needed.

  • Ability to work across all GSQ functions, including internal and external manufacturing sites, and Pharmaceutical Sciences to define directions relating for robustness technology excellence and innovation including digital solutions and data analytics.

  • Accountable for key CMC decisions and provide recommendations to have a direct impact on program's outcome.

  • Has a deep and broad understanding of small molecule product development, manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen.

  • Ability to influence broadly within GSQ organization and Takeda Product Teams to drive decisions, alignment, and conflict resolution for complex cross-functional CMC and technology excellence issues.

  • Work closely with the PMs to drive to the success of the CMC team.

  • Full accountability for complex decisions regarding the development of the SM asset.

  • Accountable for the decision relating to Life Cycle Management activities, and able to effectively manage SMEs from all functional areas to execute the decisions made.

  • Works alongside Pharmaceutical Sciences organization and influence and be accountable for decisions made having impact to the commercialization of the key asset.

  • Works across MSAT small molecule organization (including API and DP) to align CMC Development and LCM activities within the various GSQ functional organizations

  • Works across MSAT global functions as needed for business metrics and align on LCM procedures.

  • Works across MSAT small molecule (API and DP), Pharmaceutical Sciences, and Site Manufacturing Sciences groups to align on vision and priorities for LCM activities.

  • Works with the MSAT CMC LCM group on coordination of hand-off of late stage products to the commercial team.

What you bring to Takeda:
  • A bachelor degree in engineering or life sciences.

  • Minimum 10 to 15 years experience in pharmaceutical development and manufacturing.

  • Experience operating globally in a matrixed organization highly preferred.

  • Experience defining the strategy and roadmap for complex, cross-functional initiatives.

  • Strategic enterprise thinking, finding innovative ways to serve patients build reputation and trust.

  • Creating the environment that inspires and enables people.

  • Focusing on the few priorities and provide superior results.

  • Elevating capabilities for now and the future.

  • Capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.

  • Scope includes innovation in manufacturing equipment, manufacturing processes, and use of digital technology to provide data-driven approaches.

LocationsCHE - Glattpark (Opfikon) - Zurich HQUSA - MA - Cambridge

Base Salary Range:

CHF177,400.00 - CHF243,980.00

For information about our benefits, please click here.

Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time