Senior/Principal Scientist, Formulation and Process Development
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Job Description
Formulation scientist leading drug product and process development for Celcuity’s targeted oncology therapies. Supporting formulations, scale-up, lifecycle management, and regulatory filings.
Responsibilities:
- Lead projects supporting novel and existing formulations across 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 outsourced environments at contract laboratories and CDMOs
- Identify and vet new contract organizations for formulation and process development
- Help define and execute project plans for formulation lifecycle management
- Support writing technical sections for intellectual property and regulatory filings
- Develop and maintain 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 broader Celcuity team
- Summarize, document, and present information to subgroup, group, and cross-functional audiences
- Perform other duties as assigned
Requirements:
- Ph.D., M.S., or B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biochemistry, Biochemical Engineering, or related fields
- 7+ years of experience in pharmaceutical development; preferred industry experience of 4+ years for Ph.D., 5+ years for M.S., or 7+ years for B.S.
- Demonstrated experience with formulation development and drug product development, preferably for small molecule drugs
- Deep understanding of formulation techniques and considerations for sterile, parenteral dosage forms
- Knowledge of other dosage forms, such as ophthalmic or oral, beneficial
- Experience with drug-device combination products for injectable drug products preferred
- Technical expertise in formulation strategies and processes for poorly water-soluble APIs preferred
- Subject matter expertise in nano-milling and nanosuspension formulation, micro/nano-emulsions, salt formation and salt screening/selection, complexation and co-solvency using cyclodextrins or co-solvents, or lyophilization highly desirable
- Experience with physicochemical characterization methods for drug substances and drug products
- Experience with preclinical study support and early-stage formulation development
- Excellent written and verbal communication skills
- Strong interpersonal skills
- 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
- Outstanding organizational and prioritization skills
- Independent and sound decision-making skills; ability to think critically in a fast-paced environment
- Flexible, willing to learn, and able to adapt to business and site needs
- Positive, approachable, and professional attitude
Benefits:
- Annual performance incentive bonus
- New hire equity package
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) match
- PTO
- Paid holidays
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