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Formulation Development Cmc Jobs (NOW HIRING)

Lupin LTD

Formulation Scientist

Somerset, NJ · On-site

Perform formulation development, generate formula, and scale up processes in support of ANDA or NDA ... for CMC documentation, project documentation and for preparing necessary technical reports. • ...

Lupin LTD

Formulation Scientist

Somerset, NJ · On-site

Perform formulation development, generate formula, and scale up processes in support of ANDA or NDA ... Responsible for CMC documentation, project documentation and for preparing necessary technical ...

BioMarin Pharmaceutical Inc.

Sr. Scientist 1

Novato, CA · On-site

Leads drug product formulation development and optimization. * Leads the cross‑functional CMC Drug Product Partner Team and represents the team in CMC forums. * Coordinates with other partner teams ...

Atomic

CMC Consultant

Position Overview: Indomo is seeking an experienced CMC consultant to execute Chemistry ... Support outsourced drug substance and drug product development with CDMO, including formulation ...

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Formulation Development Cmc information

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How much do formulation development cmc jobs pay per hour?

As of Aug 18, 2026, the average hourly pay for 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 formulation development CMC?

Formulation Development CMC (Chemistry, Manufacturing, and Controls) refers to the process of designing and optimizing the composition of a drug product, ensuring it is safe, effective, and stable for patient use. This role involves selecting appropriate excipients, developing the manufacturing process, and generating the data required to support regulatory submissions. CMC professionals collaborate with research, quality, and regulatory teams to ensure that the drug product meets all necessary standards throughout its lifecycle.

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

To thrive as a Formulation Development CMC specialist, you need expertise in pharmaceutical sciences, chemistry, and regulatory guidelines, often supported by an advanced degree in a relevant field. Familiarity with analytical techniques, formulation equipment, and regulatory submission systems like eCTD is crucial. Strong problem-solving skills, attention to detail, and effective collaboration are essential soft skills in this role. These competencies ensure the successful development, optimization, and regulatory approval of safe and effective pharmaceutical products.

What are some typical challenges faced by professionals in formulation development CMC, and how are they addressed?

Professionals in Formulation Development CMC often encounter challenges such as ensuring formulation stability, meeting regulatory requirements, and scaling up from laboratory to manufacturing. Addressing these challenges requires close collaboration with analytical, regulatory, and manufacturing teams, as well as staying current with evolving guidelines. Effective project management, rigorous experimental design, and proactive risk assessment are key strategies to successfully navigate these complexities and ensure timely progress of drug development projects.

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

AspectFormulation Development CmcFormulation Scientist
CredentialsBachelor's or Master's in Pharmacy, Chemistry, or related fields; industry certificationsBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields
Work EnvironmentPharmaceutical or biotech R&D labs, manufacturing settingsResearch labs, development facilities, pharmaceutical companies
Industry UsageRegulatory submissions, product development, manufacturing supportFormulation research, experimental design, product optimization

Formulation Development Cmc focuses on developing formulations suitable for regulatory approval and manufacturing, often involving documentation and compliance. Formulation Scientists primarily conduct research and experiments to create and optimize formulations. While both roles require similar educational backgrounds and work in related environments, Cmc roles emphasize regulatory and manufacturing aspects, whereas Scientists focus on experimental research and innovation.

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Formulation Development Cmc jobs near you
Infographic showing various Formulation Development Cmc job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $105,849 per year, or $50.9 per hour.

Formulation Scientist

Lupin LTD

Somerset, NJ • On-site

Full-time

Posted 8 days ago

Job description

Header
Job Description
Primary Job Purpose:
Perform formulation development, generate formula, and scale up processes in support of ANDA or NDA submission batches, in a regulated development and manufacturing environment.
Position Summary
• Technical responsibility for interpreting, organizing, executing and coordinating assignments and assigned development projects.
• Maintains liaison with individuals and units within or outside of the organization as directed by Product Development Management.
• Plans, organizes and supervises the assigned work staff of associates and technicians.
• Responsible for project management of assigned product development projects.
• Responsible for the production of clinical supplies.
Duties and Responsibilities
• Review Literature and gather patent and published articles on the selected projects.
• Analyze and interpret results in written and oral format in consultation with Product Development Management.
• Determine best possible strategy for formulating assigned projects and meet regulatory criteria.
• Perform pre-formulation studies and physical-chemical characterization of materials and dosage forms.
• Perform formulation experiments to develop ANDA or NDA submission batches.
• Responsible for CMC documentation, project documentation and for preparing necessary technical reports.
• Perform all the processing steps such as weighing, blending, milling, compression etc.
• Directs the work and schedules of technicians and provides technical assistance to associates and other formulation scientists.
• Maintain accurate lab notebooks and complete all related development reports, in compliance with departmental needs and SOPs.
• Ensure equipment and materials are available in a timely fashion for submission batches and to coordinate with the manufacturing department as needed.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and safety practices.
Qualification and Experience
Master's degree (or higher) in a pharmaceutical science field preferred.
Minimum 4 years of experience in pharmaceutical drug product development, preferably in generic pharmaceuticals.
Technical expertise necessary to design pharmaceutical products and manufacturing processes.
Proven ability to supervise technical and operational personnel.Lupin Pharmaceuticals is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable laws. Lupin is dedicated to maintaining a workplace where everyone feels respected, valued, and empowered to contribute.
Competencies
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility

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