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Pharmaceutical Formulation Development Cmc Jobs

Socket.dev

Scientist I, Drug Product

Redwood City, CA · On-site

Familiarity with formulation and process development concepts for small molecule drug products is preferred. * Basic understanding of pharmaceutical development, CMC principles, and global regulatory ...

TekSky

Hot-melt Extrusion Specialist

Buffalo, NY · On-site

Knowledge of pharmaceutical formulation development * Excellent documentation and analytics skills, including SOPs and batch records * Excellent project management skills * Ability to work in a team ...

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Pharmaceutical Formulation Development Cmc information

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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.

Executive Director, Process Development & CMC Lead

Danbury, CT • On-site

BioCT Innovation Commons
See more jobs at BioCT Innovation Commonsexternal

Other

Posted 13 days ago

Key responsibilities

  • Lead process development, scale-up, technology transfer, and manufacturing readiness activities across pipeline and lifecycle programs.

  • Serve as CMC Lead for one or more development programs, chair cross-functional CMC teams, and drive integrated plans.

  • Develop and execute phase-appropriate CMC strategies for late-phase development, regulatory submissions, and commercial launch readiness.

Job description

MannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient‑centric solutions, developing and commercializing innovative inhaled therapeutics and drug‑device technologies aimed at addressing serious unmet needs across endocrine, cardiorenal, and orphan lung diseases. The company applies deep expertise in formulation science and inhalation‑device engineering to reduce the treatment burden for conditions such as diabetes, congestive heart failure, pulmonary fibrosis, and pulmonary hypertension. MannKind’s core technologies, including ultrafine dry‑powder formulations and advanced inhalation platforms, enable rapid, convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms, MannKind aims to bring forward differentiated, patient‑centric therapies that expand treatment options to improve outcomes across chronic and rare diseases.

At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.

Job Summary:

The Process Development & CMC Lead will provide strategic and technical leadership for the Process Development group while also serving as the CMC Lead for one or more development programs. This role is responsible for process development, scale-up, technology transfer, manufacturing readiness, and integrated CMC execution across MannKind's pipeline. The ideal candidate will have significant late-phase development experience, including Phase 3 execution, regulatory submissions, process validation, PPQ strategy, and commercial launch readiness for complex, inhaled, or particle‑engineered products.

This position is located in Danbury, Ct and requires onsite presence Monday-Thursday, Fridays are remote.Key Responsibilities:
  • Lead Process Development Activities: Provide strategic and technical leadership for process development, scale-up, process characterization, technology transfer, and manufacturing-readiness activities across pipeline and lifecycle programs.
  • Lead CMC Teams: Serve as CMC Lead for one or more development programs, chair cross‑functional CMC teams, drive integrated plans, and align Process Development, Formulation, Analytical, Quality, Regulatory, Clinical Manufacturing, Supply Chain, and external partners.
  • Late‑Phase Development Strategy: Develop and execute phase‑appropriate CMC strategies for Phase 2, Phase 3, registration, process validation, PPQ, and commercial launch readiness.
  • Regulatory Leadership: Own or contribute to relevant Module 3 / IND / NDA / MAA CMC sections, support health authority interactions, and ensure CMC strategies are aligned with FDA, EMA, and other regulatory expectations.
  • Technology Transfer and Manufacturing Readiness: Lead technology transfer activities, establish manufacturing control strategies, and ensure scalable, robust, and compliant processes.
  • Quality and GMP Partnership: Partner effectively with Quality to ensure phase‑appropriate GMP discipline, data integrity, investigation support, SOP alignment, and inspection readiness without creating unnecessary development burden. Proactively identify, assess, and mitigate quality and compliance risks while maintaining development agility and efficient program execution.
  • Resource and Portfolio Management: Establish departmental priorities, manage resources and budgets, and ensure Process Development capabilities are aligned with CMC program needs and corporate priorities. Partner with senior leadership to evaluate portfolio opportunities, assess CMC investment requirements, and provide strategic recommendations that support corporate objectives and program success.
  • Team Leadership: Build, lead, coach, and develop a high‑performing Process Development team with clear accountability, strong cross‑functional collaboration, and consistent execution against commitments.
  • Risk Management and Escalation: Identify and manage technical, operational and program‑level CMC risks, drive mitigation plans, make clear recommendations, and elevate issues early with options, trade‑offs, and decision points.
Qualifications:
  • PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biomedical Engineering, Mechanical Engineering, or a related field with 18+ years of relevant experience; or MS/BS with 20+ years of relevant pharmaceutical development experience.
  • Significant people‑management experience leading scientists, engineers, managers, or cross‑functional technical teams.
  • Demonstrated experience leading Process Development, Manufacturing Science and Technology, Technical Operations, or CMC functions for complex pharmaceutical products.
  • Proven experience serving as a CMC Lead, program technical lead, or equivalent cross‑functional development leader.
  • Direct late‑phase development experience, ideally including Phase 3 execution, NDA/MAA preparation, process validation, PPQ planning, and commercial launch readiness.
  • Strong understanding of drug product, drug substance, analytical, formulation, process development, manufacturing, and regulatory CMC interdependencies.
  • Experience with technology transfer to internal manufacturing sites and/or CDMOs.
  • Experience authoring, reviewing, or defending CMC sections of regulatory filings and supporting health authority questions or inspections.
  • Strong communication, collaboration, and stakeholder‑management skills, including the ability to communicate complex technical issues clearly to senior leadership.
  • Ability to operate effectively in a fast‑paced, resource‑constrained development environment with shifting priorities.
Preferred Skills:
  • Experience with inhaled drug products, dry powder inhalers, particle‑engineered products, complex dosage forms, or drug‑device combination products.
  • Experience taking at least one product through late‑stage development, regulatory submission, validation, approval, or commercial launch.
  • Familiarity with QbD, control strategy development, process characterization, continued process verification, and lifecycle management.
  • Experience working with FDA, EMA, notified bodies, or other regulatory agencies on CMC, combination product, or manufacturing‑readiness topics.
  • Experience building or improving development‑stage CMC infrastructure, operating models, decision frameworks, SOPs, templates, or governance practices.
  • Experience leading teams through technical disagreement, quality interface issues, and cross‑functional decision‑making with a clear, collaborative, and accountable style.
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