Director, API Development

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🕒 April 21

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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

• Provide leadership and technical guidance for selection, transfer, and management of new CDMO manufacturing activities. • Lead current drug substance manufacturing process and optimize for continuous improvement of material. • Support ongoing CDMO manufacturing activities and troubleshoot issues and non-conformities. • Determine and resolve gaps for regulatory compliance with drug substance manufacturing and development. • Support formulation development with drug substance optimization, impurity identification, and pre-clinical study coverage involvement. • Author and review drug substance IND-enabling protocols, reports, and regulatory submissions. • Engage and support formulation development with new entity optimization and synthetic route creation/advancement. • Produce intellectual patent assessments and complete development projects intended for furthering IP generation. • Other duties as assigned.

🎯 Requirements

• PhD, Master’s, or Bachelor’s degree in a physical science field, ideally chemistry, chemical engineering, or biomanufacturing. • ≥ 8 years in small molecule medicinal chemistry, API development, and/or manufacturing. • Experienced with early development activities including IND-enabling development and authoring. • Managed CDMOs for initial development, manufacturing, process validation, and transfer activities. • Knowledge of analytical technologies including LC, GC, NMR, MS, XRPD, and other relevant methodologies used for elucidation and purity determination. • Well-informed of FDA, EU, and ICH guidelines for drug substance manufacturing and quality assurance. • Excellent written and verbal communication skills, with ability to influence and build credibility at all levels. • Strong interpersonal skills for interacting with employees and leaders across various levels and functions. • Attention to detail and ability to manage multiple processes and documentation requirements. • Highly organized with documentation associated with project planning, communication, and resulting reports. • Strong technical and analytical skills with advanced knowledge in ChemDraw, and MS Office including Word, Excel, and PowerPoint. • 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. • Maintain a positive, approachable and professional attitude.

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • 401(k) match • Paid time off • Paid holidays • Annual performance incentive bonus • New hire equity package