ZipRecruiter

Log In

1

Cmc Small Molecules Jobs (NOW HIRING)

Retro

CMC Regulatory Lead

Redwood City, CA · On-site

$200K - $240K/yr

Be accountable for the regulatory CMC activities for Retro's programs, which include both cell therapies and small molecules. * Develop the regulatory CMC strategy for each program and lead the ...

Retro

CMC Regulatory Lead

Redwood City, CA · On-site

$200K - $240K/yr

Be accountable for the regulatory CMC activities for Retro's programs, which include both cell therapies and small molecules. * Develop the regulatory CMC strategy for each program and lead the ...

Retro

CMC Regulatory Lead

Redwood City, CA · On-site

$200K - $240K/yr

Be accountable for the regulatory CMC activities for Retro's programs, which include both cell therapies and small molecules. * Develop the regulatory CMC strategy for each program and lead the ...

next page

Showing results 1-20

All JobsCmc Small Molecules Jobs

Cmc Small Molecules information

See salary details

$14

$26

$45

How much do cmc small molecules jobs pay per hour?

As of Jul 14, 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 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 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 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.
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:
What job categories do people searching Cmc Small Molecules jobs look for? The top searched job categories for Cmc Small Molecules jobs are:
Cmc Small Molecules jobs near you
Associate Director, Regulatory Affairs - CMC

Associate Director, Regulatory Affairs - CMC

PTC Therapeutics

Warren, NJ • On-site

Full-time

Medical, Dental, Vision, Retirement

Posted 20 days ago

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
Visit our website to learn more about our company and culture!
Site: www.ptcbio.com
Job Description Summary:
The Associate Director, Regulatory Affairs - CMC will be responsible for leading global regulatory CMC strategy for product development and registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) according to global regulatory expectations and requirements.
This position works cross-functionally with Regulatory Affairs, Technical Operations, and Quality to facilitate the completion of regulatory filing documentation in accordance with company timelines.
This position ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:
Responsibilities:
  • Leads and manages the development and preparation of CMC-related submission documents for small molecule products in collaboration with Technical Operations, Quality, and Regulatory Affairs to ensure they are organized, logical, and meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle. The submissions include, but not limited to, new drug marketing applications (eg NDA, MAA, NDS, etc), electronic Common Technical Documents (eCTDs), investigational new drug applications (eg INDs, CTAs), briefing documents, response to queries, Orphan Drug Applications, and annual reports.
  • Leads global post-approval CMC regulatory strategy for commercial products, providing CMC regulatory leadership for lifecycle changes (e.g., manufacturing site changes, scale-up/tech transfer, process improvements, control strategy updates, and analytical method changes) to ensure supply continuity and align data packages to regional requirements.
  • Collaborates with Regulatory Affairs Team to develop robust global regulatory CMC strategy and risk mitigation to enable successful regulatory submissions and approvals for drug development and registration.
  • Manage or assist with regulatory agency interactions.
  • Effectively interprets and applies regulatory guidance. Provides regulatory guidance, recommendations and solutions to cross functional teams and key stakeholders.
  • Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review, and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality.
  • Supports best practice for regulatory CMC compliance activities including, but not limited to, change controls, post-marketing commitments, product complaints, and regulatory inspections.
  • Remains current on CMC regulatory intelligence including guidelines and compendial requirements

Qualifications:
Bachelor's degree in scientific discipline. A minimum of 7-8 years Regulatory Affairs experience and/or CMC technical writing experience in a pharmaceutical, biotechnology or related environment. Advanced degree a plus.
  • Technical knowledge in small molecules with experience in translating to a regulatory document
  • Demonstrated, hands-on experience in pharmaceutical development, registration, and post-approval life cycle management in a global environment.
  • Prior experience within a GMP environment with a firm understanding of industry regulations and best practices
  • Excellent working knowledge of the ICH region regulations for small molecule drugs.
  • Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, NDS, briefing documents, and response to agency queries.
  • Ability to influence without direct authority.
  • Demonstrated excellent collaboration skills.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Proficiency with Microsoft Office.
  • Advance academic degree (Masters or PhD).
  • Regulatory experience in non-CMC related matters.
  • Regulatory experience in supporting development and registration in ex-ICH regions

Travel requirements- Up to 10% travel
Expected Base Salary Range:
$169,100 - $212,800. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page

Apply