The Opportunity:

Are you a seasoned process chemist who enjoys working on drug substance projects? Do you love working closely with pharmaceutical development teams and external collaborators to seamlessly transition process development and help drug substance scale up and manufacturing efforts? In this role, you will be responsible for managing the chemical development and external manufacturing activities of our drug substance, you will have the opportunity to work across the various programs in our pipeline spanning from late research through clinical trials and beyond.

Your Role:

• Manage all small molecule drug substance development and manufacturing activities at global CRO/CMO site. Ensure regulatory compliance at vendor site.
• Lead drug substance development efforts toward the IND and clinical development of the small molecule drug candidates.
• Display the leadership and technical skills necessary to lead a chemistry project conducting development and manufacturing activities at CRO/CMO site with minimal supervision.
• Identify and develop in- process controls for potential commercial process validation. Act as the key technical transfer resource, in implementation of optimized processes on manufacturing scale. Trouble shoot and conduct problem solving of synthetic and scale-up issues.
• Review and approve specifications batch records and other critical documents.
• Write and review regulatory documents.

Your Background: 

• Ph.D. or equivalent with 7+ years of relevant Process Development and manufacturing, tech transfer experience in a virtual pharmaceutical industry.
• Demonstrated ability in cGMP and the development of synthetic methodology and scale-up of new technology.
• Analytical skills should include all modern spectroscopic techniques including: NMR experimentation and techniques; IR; mass spectroscopy, ReactIR and UV/Vis; separation techniques including chromatography: HPLC, GC, TLC, flash chromatography, chiral separations and derivitization; gravimetric analysis and titration.
• Complete familiarity with the chemical literature and literature searching techniques are required.
• Good verbal and written communication skills are essential. Strong interpersonal skill set to effectively work with internal and external stakeholders.
• Knowledge of US FDA and EMEA and ICH guidelines.
• Work efficiently with multidisciplinary teams within the company and CMO sites.  

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