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Formulation Scientist Cmc Jobs (NOW HIRING)

Develops and executes formulation strategies related to product development (i.e., project planning ... Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory ...

## Scientist, Process Development (Formulation)Applylocations: Norwood, Massachusetts: Technical ... CMC, and Quality partners as needed.* Stay current with advances in protein/enzyme formulation ...

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Formulation Scientist Cmc information

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How much do formulation scientist cmc jobs pay per hour?

As of Sep 10, 2026, the average hourly pay for formulation scientist cmc in the United States is $37.61, according to ZipRecruiter salary data. Most workers in this role earn between $25.24 and $43.51 per hour, depending on experience, location, and employer.

What is a formulation scientist CMC?

A Formulation Scientist CMC (Chemistry, Manufacturing, and Controls) is a professional responsible for developing and optimizing the composition and manufacturing process of pharmaceutical products. They work to ensure that drugs are stable, effective, and safe for use, overseeing formulation development, scale-up, and transfer to manufacturing. Their role involves collaborating with analytical, regulatory, and manufacturing teams to ensure compliance with industry standards and regulatory requirements throughout the product lifecycle.

How does a formulation scientist CMC typically collaborate with cross-functional teams during drug development projects?

As a Formulation Scientist CMC, you will work closely with colleagues from analytical chemistry, regulatory affairs, process development, and quality assurance. Your role involves coordinating with these teams to ensure that formulations are developed in compliance with regulatory guidelines and meet project timelines. Regular meetings, data sharing, and joint problem-solving sessions are common, and strong communication skills are essential to align priorities and resolve technical challenges efficiently. This collaborative environment also provides opportunities to learn from other disciplines and contribute to the overall success of product development.

What are the key skills and qualifications needed to thrive as a formulation scientist CMC, and why are they important?

To excel as a Formulation Scientist CMC, you need a solid background in pharmaceutical sciences, chemistry, or related fields, often with an advanced degree and experience in formulation development. Familiarity with analytical instrumentation, regulatory guidelines (such as ICH and FDA), and quality control systems is vital. Strong problem-solving abilities, effective communication, and attention to detail are essential soft skills for success in this role. These competencies ensure robust product development, regulatory compliance, and successful cross-functional collaboration throughout the drug development process.

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

AspectFormulation Scientist CmcFormulation Scientist
Required CredentialsBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fieldsBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields
Work EnvironmentPharmaceutical or biotech labs focused on drug development and manufacturingPharmaceutical or biotech labs involved in drug formulation and development
Employer & Industry UsagePrimarily in pharmaceutical companies, biotech firms, and CDMOsCommonly in pharmaceutical and biotech industries, especially in formulation development

The main difference between a Formulation Scientist Cmc and a Formulation Scientist lies in their focus areas. CMC (Chemistry, Manufacturing, and Controls) emphasizes regulatory compliance, manufacturing processes, and quality aspects, while a general Formulation Scientist may focus more broadly on formulation development without specific regulatory responsibilities. Both roles require similar educational backgrounds and work environments, but CMC specialists often work closely with regulatory teams to ensure compliance with industry standards.

What are popular job titles related to Formulation Scientist Cmc jobs?

For Formulation Scientist Cmc jobs, the most frequently searched job titles are:

Infographic showing various Formulation Scientist Cmc job openings in the United States as of September 2026, with employment types broken down into 3% Internship, 1% As Needed, 89% Full Time, 4% Part Time, and 3% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $78,236 per year, or $37.6 per hour.

Associate Scientist, CMC (Gene Therapy)

San Diego, CA • On-site

Leo Pharma
Manufacturing • 1 - 5K employees

$100K - $110K/yr

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.


Job description

Application deadline: 12 Sep 2026
Location: San Diego 92121, California, United States
Contract type: Permanent
Job ID: 4836
Bring your scientific curiosity to the bench and help shape the future of gene therapy CMC.
In this hands-on role, you will turn complex science into robust processes, meaningful data, and practical solutions that help move an HSV-1 gene therapy program forward.
About Replay, now part of LEO Pharma
Replay Holdings, Inc. ("Replay"), now part of LEO Pharma, is advancing the future of gene therapy for patients with rare disease. A gene therapy company focused on HSV-based vectors for topical dermatology applications, Replay combines the agility of a small, high-impact team with the global reach and patient commitment of LEO Pharma.
In CMC, Process & Analytical Development, we share a "challenge accepted" mindset and are guided by simplification, collaboration, and accountability to achieve our goals.
Your role
As Associate Scientist, CMC, you will be an independent bench scientist supporting upstream, downstream, formulation, and analytical workstreams for our gene therapy program. You will design and execute experiments, troubleshoot technical challenges, interpret data, and help build phase-appropriate methods and processes.
This is a role for a scientist who enjoys hands-on laboratory work, scientific problem solving, and contributing in a fast-paced, cross-functional environment.
You will:
  • Independently design, execute, and troubleshoot experiments across cell culture, viral production, purification, formulation, and analytical workflows.
  • Develop, optimize, and support qualification of assays and process steps for an HSV-1 gene therapy program.
  • Run vector characterization and release-relevant assays, including viral titer, genome quantitation, potency, and impurity/residual testing.
  • Author and revise protocols, SOPs, technical reports, and development summaries in line with data integrity and Good Documentation Practices.
  • Support analytical method and process transfer to CDMOs, including review of data packages and resolution of technical questions.

The role also offers the opportunity to contribute to control strategy, specification setting, stability programs, and the day-to-day technical guidance of research associates.
This is a highly visible opportunity to work close to the science in a collaborative, resource-conscious team where your work can directly influence development decisions. You will gain exposure across CMC disciplines, contribute to external partner interactions, and help build rigorous processes in a dynamic gene therapy setting.
Your qualifications
To succeed in this role, we imagine that you have deep scientific training and hands-on experience in biologics, viral vectors, or related CMC development. You are comfortable working independently at the bench and can translate experimental results into clear conclusions and next steps.
  • Hands-on experience in at least one CMC area: cell culture/upstream, purification/downstream, formulation, or analytical development is a requirement for this role.
  • Bachelor's degree in biology, biochemistry, virology, microbiology, biomedical engineering, or chemical engineering with 4+ years of relevant laboratory experience OR Master's degree with 2+ years of related experience.
  • Experience developing, optimizing or troubleshooting process steps.
  • Viral vector CMC experience, preferably HSV; experience with AAV, lentivirus, or adenovirus is also relevant.
  • Familiarity with qPCR/ddPCR, viral titer or potency assays, GMP expectations, ICH/FDA guidance, and method or process transfer to CDMOs.

You will bring competent technical writing, sound data interpretation skills, and basic statistical understanding. You communicate clearly, work well across functions, and thrive in a hands-on, safety-first laboratory environment.
Your new team
You will join CMC - Process & Analytical Development in San Diego, working on-site five days per week in a BSL-2 laboratory. The team works cross-functionally across process, analytical, formulation, quality, and external partner activities. You will be part of a small, ambitious group where collaboration, scientific rigor, and practical problem solving are essential.
Compensation
The base salary range for this position is $100,000 - $110,000. The base salary range represents the anticipated low and tier of the range for this position. Salary will vary depending on several factors such as the candidates' qualifications, skills, competencies and proficiency for the role. In addition, some positions may include eligibility to earn commission/bonus based on company and/or individual performance.
Your Application
You do not need to upload a cover letter, but feel free to add a few sentences in your resume on why this position sparked your interest. Please refrain from including a photograph.
Beyond the skin
Become part of Replay and the LEO Pharma partnership, as we go beyond the skin to make a lasting impact. We are the legacy-builders of the future - enabling people to have a better today and tomorrow. Through collaboration and partnerships, we can do much more.
For certain positions, you may be required to complete a background check conducted by a third party.
Join us and make an impact - Together, we reach far beyond the skin