Associate Director, Drug Substance

The Opportunity

This is a highly visible leadership opportunity to join an attractive discovery-based company that has diverse early and potential late-stage pipeline of drug candidates. In this role you will provide leadership in development and execution of robust and cost-effective processes for new small molecule APIs.

Your Role

• Manage all late-stage small molecule drug substance development and manufacturing activities at global CRO/CMO sites.
• Ensure regulatory compliance at vendor site.
• Lead all late-stage drug substance development efforts toward the commercialization of the small molecule drug candidates.
• Display the leadership and technical skills necessary to lead the development and manufacturing activities at CRO/CMO sites 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 scale-up and manufacturing issues.
• Review and approve specifications, batch records and other critical documents.
• Work with other process chemists to support early-stage manufacturing process development/manufacturing and move the project to late-stage development.
• Collaborate with QC, supply chain and quality assurance to ensure alignment on deliverables.
• Write and review regulatory documents (NDA and MAA).

Your Background

• Bachelor or above in chemical engineering/Ph.D. or equivalent in organic chemistry with 7+ years of relevant late-stage Process Development and manufacturing, tech transfer experience in a virtual pharmaceutical industry.
• Demonstrated ability in late-stage manufacturing process development, validation, and commercial manufacturing at global CMOs in an accelerated environment.
• Demonstrated ability in cGMP and the development of synthetic methodology and scale-up of new technology.
• Experience with QbD tools including risk assessment, design of experiments and data analysis, process analytical technologies and their application in identifying CQA, CPP and establishing the appropriate control strategy.
• Strong outsourcing experience in working with external partners.
• 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; solid state characterization; gravimetric analysis and titration.
• Complete familiarity with the chemical literature and literature searching techniques are required.
• Strong communication, analytical and problem-solving skills.
• 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.
• Experience in process validation and NDA or MAA filing is must.

Estimated Salary Range

[$145,000 - $207,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.

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