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Pharmaceutical Formulation Development Cmc Jobs

RXinsider LTD.

... Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every ... Lead or contribute to CMC sections of regulatory dossiers (ANDA, NDA, 505(b)(2) -- formulation ...

Curium

Director, Early Development CMC

Saint Louis, MO · On-site

... formulation, analytical development, and regulatory CMC requirements. The Director will serve as ... Experience: 1015 years of pharmaceutical or biotechnology industry experience. Significant CMC ...

New

BioCT Innovation Commons

$65K - $80K/yr

Participate in customer formulation development projects (primarily pharmaceutical) and development of new drug delivery technologies as a hands-on laboratory scientist/engineer * Perform solid ...

BioCT Innovation Commons

$90K - $110K/yr

Participate in customer formulation development projects (primarily pharmaceutical) and development of new drug delivery technologies as a hands-on laboratory scientist/engineer * Collaborate with ...

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How much do pharmaceutical formulation development cmc jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for pharmaceutical formulation development cmc in the United States is $50.89, according to ZipRecruiter salary data. Most workers in this role earn between $34.62 and $81.49 per hour, depending on experience, location, and employer.

What is pharmaceutical formulation development CMC?

Pharmaceutical Formulation Development CMC (Chemistry, Manufacturing, and Controls) refers to the process of designing and optimizing the composition and manufacturing process of a drug product. It involves selecting the appropriate drug formulation, developing manufacturing processes, and ensuring the product meets quality, safety, and efficacy standards. CMC documentation is crucial for regulatory submissions and approval, as it provides detailed information about the drug's composition, production, and quality control procedures. This discipline is essential for translating new drug discoveries into safe, effective, and commercially viable products.

What are the key skills and qualifications needed to thrive as a pharmaceutical formulation development CMC specialist?

To thrive in Pharmaceutical Formulation Development CMC, you need a solid foundation in pharmaceutical sciences, chemistry, and regulatory guidelines, typically supported by an advanced degree in pharmacy, chemistry, or related fields. Familiarity with analytical instrumentation, formulation software, and regulatory submission systems (such as CTD/eCTD) is crucial, along with knowledge of GMP and ICH guidelines. Strong problem-solving, project management, and cross-functional communication skills set top performers apart in this role. These competencies are critical for ensuring that drug products are safe, effective, and compliant with regulatory standards throughout the development lifecycle.

What are some common challenges faced in pharmaceutical formulation development CMC roles, and how are they typically addressed?

One common challenge in pharmaceutical formulation development CMC (Chemistry, Manufacturing, and Controls) roles is balancing the need for innovative drug formulations with strict regulatory requirements. Formulation scientists often need to troubleshoot stability issues, optimize drug delivery systems, and ensure scalability for manufacturing. These challenges are typically addressed through close collaboration with analytical, regulatory, and manufacturing teams, as well as thorough documentation and robust risk assessments. Staying up to date with the latest industry guidelines and maintaining clear communication across departments are key practices for overcoming these challenges.

What is the difference between Pharmaceutical Formulation Development Cmc vs Pharmaceutical Quality Assurance Specialist?

AspectPharmaceutical Formulation Development CmcPharmaceutical Quality Assurance Specialist
Primary FocusDeveloping and optimizing drug formulations and manufacturing processesEnsuring product quality, compliance, and regulatory standards
Work EnvironmentLaboratories, R&D settings, manufacturing sitesQuality control labs, regulatory departments, manufacturing oversight
Required CredentialsDegree in pharmacy, chemistry, or related field; experience in formulation developmentDegree in pharmacy, chemistry, or related; knowledge of GMP and quality systems

While both roles require a background in pharmaceutical sciences, Pharmaceutical Formulation Development Cmc focuses on creating and refining drug formulations, whereas Pharmaceutical Quality Assurance Specialists ensure these formulations meet quality and regulatory standards. Both roles are essential in bringing safe, effective medicines to market.

Pharmaceutical Formulation Chemist

Temecula, CA • On-site

K2 Staffing
Recruiting and Staffing Services • 11 - 50 employees
Learn more about K2 Staffingexternal

Contractor

Re-posted 18 days ago

Job description

Summary

Our client is seeking an experienced Formulation Chemist to support the development of lyophilized injectable vials and oral capsule formulations on a project-based (Statement of Work / Per Diem) basis. This role is ideal for a pharmaceutical formulation expert with hands-on experience developing injectable and oral solid-dose products who can independently lead formulation activities from concept through regulatory readiness.

The successful candidate will have expertise in formulation development, excipient selection, lyophilization, stability studies, GMP documentation, and technical writing while collaborating with Quality, Regulatory, Manufacturing, and Analytical teams to support product commercialization.

Duties & Responsibilities Formulation Development
  • Develop formulations for lyophilized injectable vials and oral capsule products.
  • Design and execute formulation development studies, including excipient selection, buffer optimization, and compatibility assessments.
  • Troubleshoot formulation challenges related to solubility, stability, aggregation, dissolution, and product performance.
  • Support scale-up activities from laboratory development through manufacturing.
Lyophilization & Injectable Products
  • Develop and optimize lyophilization cycles, including freezing, primary drying, and secondary drying.
  • Investigate and resolve reconstitution and product stability issues.
  • Support sterile fill-finish activities, ensuring compatibility with filtration systems and filling equipment.
Oral Solid Dose Development
  • Develop oral capsule formulations, including excipient compatibility and fill-weight uniformity.
  • Evaluate formulation performance and identify opportunities to improve bioavailability where appropriate.
  • Generate technical data packages supporting manufacturing partners.
Stability, Documentation & Regulatory Support
  • Design and execute accelerated and long-term stability studies in accordance with ICH guidelines.
  • Prepare formulation development reports, technical protocols, batch records, and supporting GMP documentation.
  • Collaborate with Quality and Regulatory teams to ensure formulation data supports regulatory compliance, including 503A/503B requirements.
  • Support manufacturing and analytical teams by providing formulation expertise throughout the product lifecycle.
Qualifications & Requirements Required Experience
  • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline (PhD preferred).
  • Minimum 3 years of pharmaceutical formulation experience developing both injectable (lyophilized) and oral solid-dose products.
  • Hands-on experience with lyophilization cycle development and freeze-drying equipment.
  • Experience developing oral capsule formulations, including excipient selection and fill-weight optimization.
  • Strong understanding of formulation challenges, including solubility, stability, aggregation, and excipient compatibility.
Technical Skills
  • Experience designing and executing formulation development studies.
  • Knowledge of GMP documentation, batch records, technical protocols, and formulation reports.
  • Familiarity with ICH stability guidelines and stability protocol development.
  • Understanding of USP <795>, USP <797>, and/or 503A/503B regulatory requirements preferred.
  • Experience supporting sterile fill-finish operations and aseptic processing is highly desirable.
Professional Skills
  • Strong technical writing and documentation skills.
  • Excellent analytical, problem-solving, and troubleshooting abilities.
  • Ability to work independently while collaborating with cross-functional teams.
  • Strong organizational skills with the ability to manage multiple project priorities.
Employment Type: Contract Location: Temecula, CA