Senior Scientist, Formulation and Process Development

🕒 2 days ago

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $500M Post-IPO Debt - Celcuity on 2025-09

Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that comprehensively block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead product candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor in late-stage clinical development (including Phase 3 VIKTORIA trials) for HR+/HER2- advanced breast cancer and other indications such as prostate cancer. The company advances a focused pipeline of PAM pathway inhibitors, publishes clinical data, engages with investors and regulators, and is mission-driven to improve outcomes for cancer patients.

📋 Description

• 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.

🎯 Requirements

• 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. • 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, dental, and vision insurance • 401(k) match • PTO • Paid holidays • Eligible for an annual performance incentive bonus • New hire equity package