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Senior Scientist, Formulation and Process Development

Research ScientistResearch ScientistFull TimeRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

88 days ago

Salary

$150K - $175K / year

Seniority

Senior

Bachelor Degree7 yrs expEnglishSaltStack

Job Description

Senior Scientist, Formulation and Process Development

Celcuity

• Lead projects to support development of novel and existing formulations, spanning the product lifecycle including pre-formulation, dosage form selection, formulation development, process development, and manufacturing scale-up. • Design, execute, and interpret formulation and process development experiments in an outsourced environment at contract laboratories and CDMOs. • Identify and vet new contract organizations to support formulation and process development. • Help define & execute the project plans for formulation lifecycle management. • Support writing technical sections for intellectual property and regulatory filings. • Develop and maintain an in-depth knowledge of formulation development trends, techniques, and technologies. • Serve as a subject matter expert for formulation development within the Pharmaceutical Development group and the broader Celcuity team. • Summarize, document, and present information to subgroup, group, and cross-functional audiences. • Other duties as assigned.

Job Requirements

  • D/M.S./B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biochemistry, Biochemical Engineering, or related fields.
  • 7+ years of experience in pharmaceutical development (preferred 4+ years industry experience for Ph.D; 5+ years for M.S.; 7+ years for B.S.).
  • Demonstrated experience with formulation development and drug product development, preferably for small molecule drugs.
  • Deep understanding of formulation techniques & considerations for sterile, parenteral dosage forms.
  • Knowledge of other dosage forms (e.g., for ophthalmic or oral) is beneficial.
  • Experience with drug device combination products for injectable drug products (e.g., prefilled syringes, autoinjectors) is preferred.
  • Technical expertise in formulation strategies and processes specifically tailored to poorly water-soluble APIs is preferred. Subject matter expertise in one or more of these areas is highly desirable:
  • Nano-milling and nanosuspension formulation.
  • Micro/nano-emulsions.
  • Salt formation and salt screening/selection.
  • Complexation and co-solvency using cyclodextrins or co-solvents.
  • Experience with physicochemical characterization methods for drug substances and drug products.
  • Excellent written and verbal communication skills, with ability to influence and build credibility at all levels.
  • Strong interpersonal skills for interacting with colleagues across various levels and functions.
  • Attention to detail and ability to manage multiple processes and documentation requirements.
  • Strong technical and analytical skills with advanced knowledge in MS Office products.
  • Ability to work in a team or independently as required.
  • Outstanding organizational skills with the ability to prioritize.
  • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment.
  • Flexible and willing to learn; able to adapt to business and site needs in a dynamic environment.
  • Maintain a positive, approachable and professional attitude.

Benefits

  • medical insurance
  • dental insurance
  • vision insurance
  • 401(k) match
  • PTO
  • paid holidays
  • annual performance incentive bonus
  • new hire equity package

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