Remote Senior/Principal Scientist, Formulation & Process Dev

Celcuity Inc.; United States; Remote; USD 150,000 - 175,000; Full time

Job summary

Celcuity is seeking a Senior or Principal Scientist, Formulation and Process Development, to lead formulation and process development work supporting Celcuity’s drug product development and product lifecycle management. The Sr./Principal Scientist role will join a collaborative Pharmaceutical Development group focused on advancing Celcuity’s lead drug candidates.

This position will be remote. The role will lead projects spanning pre-formulation, dosage form selection, formulation development,

Qualifications

• Ph.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.).
• 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., ophthalmic or oral) is beneficial.
• Experience with drug device combination products for injectable drug products (pref; includes prefilled syringes, autoinjectors).
• Technical expertise in formulation strategies and processes tailored to poorly water-soluble APIs; include nano-milling, nano-emulsions, salt formation, cyclodextrins/co-solvents, lyophilization.
• 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, with ability to influence and build credibility at all levels.
• Strong interpersonal skills for interacting across levels and functions.
• Attention to detail and ability to manage multiple processes and documentation requirements.
• Strong technical and analytical skills with MS Office; ability to work in a team or independently.
• Demonstrated independent and sound decision-making skills; able to think critically in a fast-paced environment.
• Flexible and willing to learn; adapt to business and site needs in a dynamic environment.
• Maintain a positive, approachable and professional attitude.

Responsibilities

• Lead projects to support development of novel and existing formulations spanning lifecycle from pre-formulation to 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 to support formulation and process development.
• Help define and execute project plans for formulation lifecycle management.
• Support writing technical sections for IP and regulatory filings.
• Develop and maintain knowledge of formulation development trends, techniques, and technologies.
• Serve as SME for formulation development within the Pharmaceutical Development group and Celcuity team.
• Summarize, document, and present information to subgroup, group, and cross-functional audiences.
• Other duties as assigned.

Skills

Formulation development

Parenteral dosage forms

Nanosuspension formulation

Lyophilization

Analytical skills

Education

Ph.D./M.S./B.S. in Pharmaceutical Science or related fields

Tools

MS Office

Job description

Celcuity is seeking a Senior or Principal Scientist, Formulation and Process Development, to lead formulation and process development work supporting Celcuity’s drug product development and product lifecycle management. The Sr./Principal Scientist role will join a collaborative Pharmaceutical Development group focused on advancing Celcuity’s lead drug candidates.

This position will be remote. The role will lead projects spanning pre-formulation, dosage form selection, formulation development,