Senior or Principal Scientist, Formulation and Process Development

Celcuity Inc.; Northern (KY); Hybrid; USD 150,000 - 175,000; Full time

Benefits offered by this job

Annual incentive bonus

Equity package

Medical/dental/vision insurance

401(k) match

PTO and paid holidays

Job summary

Celcuity Inc. is seeking a Senior/Principal Scientist in Formulation and Process Development. This remote role leads development of novel and existing formulations, spanning pre-formulation to manufacturing scale-up, with emphasis on poorly water-soluble APIs.

You will guide outsourced experiments, collaborate cross-functionally, and contribute to IP and regulatory filings. The role reports to the Director, Pharmaceutical Development and offers an annual bonus and equity package, with

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 (theoretical, industry experience varies by degree).
• Demonstrated experience with formulation development and drug product development, preferably for small molecule drugs.
• Deep understanding of formulation techniques for sterile, parenteral dosage forms; other dosage forms are beneficial.
• Experience with drug-device combination products, including prefilled syringes and autoinjectors, is preferred.
• Expertise in poorly water-soluble APIs and related formulation approaches (nano-milling, nanosuspensions, salt formation, complexation).
• Experience with physicochemical characterization methods for drug substances and drug products.
• Strong communication skills with ability to interact across levels and functions.
• Excellent organizational skills and ability to prioritize multiple projects.

Responsibilities

• Lead formulation and process development projects across product lifecycle, including scale-up.
• Design, run, and interpret experiments at contract labs and CDMOs.
• Identify contract organizations to support development.
• Define and execute formulation lifecycle project plans.
• Support writing of IP and regulatory documentation.
• Maintain knowledge of formulation development trends and technologies.
• Act as SME for formulation development within the Pharmaceutical Development group.
• Summarize and present data to cross-functional audiences.
• Perform other duties as assigned.

Skills

Formulation development

Drug product development

Sterile dosage forms

Parenteral delivery

Nanosuspension formulation

Lyophilization

Physicochemical characterization

Independent decision making

MS Office

Education

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

Tools

MS Office

Job description

We are seeking a Senior or Principal Scientist, Formulation and Process Development, who will report to the Director, Pharmaceutical Development. You will focus on leading 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. The Sr./Principal Scientist will lead formulation and process development projects for novel formulations targeted toward existing and new indications, as well as projects supporting Celcuity’s existing oncology drug product. This position will be remote.

Responsibilities:

• 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.

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.).
• 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. Knowledge of other dosage form delivery techniques (e.g., for ophthalmic) is beneficial.
• 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.
  • 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 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.

About Us:

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $150,000 - $175,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.