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Formulation Development Cmc Jobs in California (NOW HIRING)

This position does not oversee formulation or process development but collaborates closely with those teams to ensure analytical readiness, CMC coherence, and timely development support. The ideal ...

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Formulation Scientist

Alameda, CA · On-site

$40 - $60/hr

Design formulation development studies including lab scale and scale-up manufacturing processes for ... regulatory/CMC documents. * Possess excellent writing and verbal communication skills and strong ...

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Formulation Development Cmc information

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.

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, and why are they important?

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 cities in California are hiring for Formulation Development Cmc jobs? Cities in California with the most Formulation Development Cmc job openings:

Senior/Principal Scientist, Formulation Development

Forma Life Sciences

Irvine, CA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 9 days ago


Job description

About Forma Life Sciences
Forma Life Sciences is a next-generation CDMO headquartered in Irvine, California, where molecules become medicine. Forma supports oral solid dosage programs from early clinical development through commercial manufacturing, with deep formulation expertise and cGMP manufacturing capabilities supporting pharmaceutical partners and the patients they serve.
Position Summary
Forma is seeking a Senior or Principal Scientist, Formulation Development to support and lead formulation development activities for oral solid dosage programs in a regulated CDMO environment. The final level and title will be determined based on the selected candidate's experience, technical depth, demonstrated independence, leadership capability, and business needs.
At the Senior Scientist level, this role is expected to design, execute, troubleshoot, and support formulation development activities while leading defined workstreams and mentoring junior staff. At the Principal Scientist level, this role is expected to operate as a senior technical subject matter expert, independently develop and implement formulation strategies, lead complex investigations, guide cross-functional teams, and represent formulation development as a technical lead on client and internal programs.
Essential Duties & Responsibilities
• Design, execute, evaluate, and/or lead formulation development experiments for oral solid dosage products, including tablets, capsules, and related dosage forms.
• Develop, implement, or contribute to formulation strategies based on scientific data, manufacturability, program objectives, technical risk, and client or regulatory expectations.
• Perform and support formulation work using approaches such as dilution blending, dry granulation, wet granulation, hot-melt extrusion, spray drying, and functional coating, as applicable to program needs.
• Evaluate formulation and process data, identify technical trends or risks, and recommend next-step experiments, troubleshooting activities, or development strategies.
• Lead or support investigations of aberrant or unexpected results, including root cause assessment, scientific rationale, documentation, and recommended corrective or follow-up actions.
• Prepare, review, and, as appropriate based on level, approve scientific reports, experimental protocols, development summaries, technical memos, batch records, investigation documentation, and other development records.
• Provide technical input and guidance to Formulation Development, Analytical Development, Manufacturing, Quality, Project Management, and client-facing teams on formulation methodologies, technical risks, development challenges, and process considerations.
• Serve as a technical lead for assigned formulation workstreams or projects; at the Principal Scientist level, routinely act as group leader or subject matter expert on complex formulation programs.
• Support development, scale-up, technology transfer, troubleshooting, manufacturing readiness, and commercialization activities for pharmaceutical drug products.
• Contribute to continuous improvement, capability-building, technical training, and scientific best practices within formulation operations.
• Mentor, train, and provide technical direction to junior scientists, associates, formulation staff, or cross-functional team members as assigned.
• Comply with Forma SOPs, cGMP practices, data integrity expectations, safety requirements, and documentation standards in all laboratory, pilot, manufacturing, and technical activities.
• Maintain strict confidentiality of client, product, program, employee, and company information.
• Perform other related duties and responsibilities as assigned.
Requirements
Required Qualifications
• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline required. Relevant industry experience should generally include PhD with 2+ years for Senior Scientist level or 4+ years for Principal Scientist level; M.S. with 5+ years for Senior Scientist level or 8+ years for Principal Scientist level; or B.S. with 7+ years for Senior Scientist level or 10+ years for Principal Scientist level.
• Hands-on formulation development experience with tablets, capsules, and oral solid dosage forms, including commonly used formulation and process approaches such as blending, dry granulation, wet granulation, hot-melt extrusion, spray drying, and coating.
• Working knowledge of formulation development, CMC drug development, cGMP practices, SOP-driven documentation, data integrity, laboratory safety, and regulated development/manufacturing expectations.
• Experience preparing clear, accurate, and scientifically sound protocols, reports, technical summaries, investigation documentation, or related development records.
• Ability to analyze experimental results, troubleshoot technical issues, and communicate recommendations to scientific, cross-functional, client-facing, and leadership stakeholders.
• Demonstrated ability to manage multiple priorities in a fast-paced, client-focused CDMO environment with strong ownership, attention to detail, and follow-through.
• Excellent verbal and written communication skills and the ability to collaborate effectively with technical and non-technical team members; Principal Scientist candidates should demonstrate scientific leadership, project or group leadership, technical mentorship, and ability to guide complex formulation development work.
Preferred Qualifications
• Experience in pharmaceutical, biotechnology, life sciences, manufacturing, CDMO, or client-service environments.
• Experience supporting technology transfer, scale-up, process troubleshooting, manufacturing readiness, or commercialization activities for oral solid dosage products.
• Understanding of excipient functionality, drug substance properties, formulation chemistry, functional coatings, and immediate-release, delayed-release, or sustained-release dosage forms.
• Experience mentoring junior staff or providing technical training to laboratory, development, or cross-functional personnel.
• Strong math, chemistry, troubleshooting, interpretation, and scientific writing skills.
Benefits
Compensation & Benefits
The expected base salary range for this exempt position is $115,000 to $170,000 per year. Final compensation and title will be determined based on the candidate's relevant experience, education, skills, technical expertise, demonstrated level of independence, leadership capability, internal equity, and business needs.
Forma offers a comprehensive and competitive benefits package designed to support employee health, well-being, financial security, and overall quality of life. Benefits may include ACA-compliant medical, vision, and dental coverage; Medical FSA and Dependent Care FSA options, generous paid time off, paid sick leave, company holidays, 401(k) retirement plan, voluntary life insurance, disability insurance, critical illness, hospital, and accident insurance, legal and identity protection services, company-paid basic life and AD&D insurance, an aggressive bonus structure, monthly company events, and other company-sponsored programs, subject to plan terms and eligibility requirements.
Work Environment & Physical Requirements
This role is performed primarily in an office and laboratory/manufacturing-adjacent environment at Forma's Irvine facility. The employee may work in well-lit, heated and/or air-conditioned indoor office and laboratory areas with adequate ventilation and may be required to use a computer, review technical documentation, communicate with others, and attend meetings for extended periods.
The role may require occasional standing, walking, sitting, reaching, bending, use of laboratory or pilot-scale equipment, and other light physical activities of a productive or technical nature. Employees must follow applicable safety procedures, PPE requirements, cGMP documentation practices, and facility access requirements. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.
Equal Employment Opportunity & Reasonable Accommodation
Forma Life Sciences is an Equal Opportunity Employer. We consider qualified applicants for employment without regard to race, color, religion, creed, sex, gender, gender identity or expression, sexual orientation, reproductive health decision-making, pregnancy, childbirth or related medical conditions, breastfeeding, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, citizenship status, protected hairstyle or hair texture, or any other status protected by applicable federal, state, or local law.
Forma provides reasonable accommodations to qualified individuals with disabilities and sincerely held religious beliefs, practices, or observances, as required by law. Applicants or employees who need accommodation to participate in the hiring process or perform essential job functions should contact Human Resources.