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Formulation Development Cmc Jobs in California (NOW HIRING)

BioMarin Pharmaceutical Inc.

Sr. Scientist 1

Novato, CA · On-site

Experience with parenteral drug product formulation development, characterization, testing, quality risk assessment and CMC regulatory guidance and filings. * Strong leadership and team management ...

BioMarin Pharmaceutical Inc.

Sr. Scientist 1

Novato, CA · On-site

Experience with parenteral drug product formulation development, characterization, testing, quality risk assessment and CMC regulatory guidance and filings. * Strong leadership and team management ...

BIOMARIN PHARMACEUTICAL

Sr. Scientist 1

Novato, CA

$107K - $146K/yr

Leads drug product formulation development and optimization. Leads the crossfunctional CMC Drug Product Partner Team and represents the team in CMC forums. Coordinates with other partner teams to ...

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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.
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Formulation Development Cmc jobs near you
Associate Scientist Peptide Formulation - Contract

Associate Scientist Peptide Formulation - Contract

Protagonist Therapeutics

Newark, CA

$55 - $65/hr

Full-time

Posted 21 days ago

Job description

Scientist/Associate Scientist Peptide Formulation
Job Description
Protagonist Therapeutics located in Newark, CA is seeking a formulation scientist to support their clinical programs. This person would ideally have experience in design and development of early stage clinical formulations and process development for different delivery routes, particularly oral and parenteral formulation, as well as experience in pre-formulation. Relevant experience could be related to biologics or small molecule, with peptide experience preferred. The ideal candidate would be able to provide formulation expertise and guidance to enable developing clinical formulations for early stage clinical trials. They should be able to design and execute experiments independently in the lab and collaboratively work across all departments involved in clinical development in addition to having a good working knowledge of formulation preparation for preclinical studies.
  • The qualified candidate will be responsible for solid oral dosage form development for early and late-stage clinical trials
  • Should have experience and/or knowledge in pre-formulation, formulation development, and process selection and scale up, oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs) requirements
  • The qualified candidate will be responsible for pre-formulation, formulation development, manufacture of clinical supplies and development of efficient and scalable manufacturing processes.
Required Skills
  • Experienced in formulation and process development of solid oral dosage forms.
  • Expertise in site specific gastrointestinal drug delivery is a plus
  • Hands on experience with modern delivery technologies to enhance bioavailability of small molecule or peptides
  • Knowledge of basic analytical skills required: HPLC/MS, UV, DSC, TGA, XRPD, FTIR, DLS etc.
  • Knowledge in pharmacokinetic data generation and interpretation
  • Excellent communication skills and interpersonal skills are required.
Essential Functions
  • Works under supervision of directors to advance the development of state-of-the-art drug delivery techniques.
  • Represents pharmaceutical sciences in cross-functional team meetings. Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
  • Applies formulation development principles and techniques to products and problems. Working under general supervision, plans designs, implements and analyzes laboratory experimentation to advance scientific knowledge of drug formulations.
  • Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports company interests.
  • Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
  • Thinks critically and creatively and can work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
  • Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations
  • This is a predominantly lab based position with possibility of international or domestic travel for manufacturing oversight at CDMOs
  • Determine the optimal formulations for discovery compounds based on the delivery route, concentration requirements, and compatibility
  • Provide feedback to chemistry and biology teams to integrate formulation early into the discovery process
  • Experience with formulation laboratory techniques, such as sterile technique, pH, dissolution, lyophilization, spray drying
  • Oversight of formulation screening studies in preclinical animal models
  • Develop a formulation appropriate for Phase 1 clinical studies
  • Generate and interpret pre-formulation data, such as logP, thermal analysis, moisture content, particle size, stability etc.
Experience And Skills
  • 8+ years of experience in peptide or small molecule development with BS in chemistry, engineering, pharmaceutics, or other related scientific discipline (or) 5-8 years with MS in chemistry, engineering, pharmaceutics, or other related scientific discipline (or) 3-5 years of experience in drug formulation with PhD in chemistry, engineering, pharmaceutics, or other related scientific discipline.
  • Demonstrates excellent writing and communication skills
The base pay range for this position at commencement of employment is expected to be between $110K and $120K / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. The Company's proprietary peptide technology platform enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDEâ„¢ (icotrokinra) is approved in the U.S. for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor (IL-23R) licensed to Janssen Biotech, Inc.,a Johnson amp; Johnson company. ICOTYDE was jointly discovered by Protagonist and Johnson amp; Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson amp; Johnson assuming responsibility for further development and commercialization. An NDA for rusfertide, a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024, is under priority review with the FDA. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.

More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.

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