Associate Director, Chemical Development Permanent

We’re looking for a candidate to fill this position in an exciting company.

• The scope of the role encompasses a wide breadth of lifecycle, ranging from early stage development, late stage development, process validation, early commercial manufacturing, contribution towards CMC content for regulatory submissions, regulatory approval and product life cycle management.
• The role will be critical in ensuring we optimize development, reduce risk profiles and ultimately accelerate the development cycle of assets.
• S/he will be expected to manage these activities using an outsourcing model and to work within a cross-functional team environment of external service providers and internal team members to help define project scope and plan, and ensure successful delivery with regards to process development, technical troubleshooting, quality, compliance, milestone timelines and project budget. S/he will be responsible for building/maintaining strong working relationships with their respective staff and management.
• The candidate will identify opportunities and activities that can enable the scale up of drug candidates for pre-clinical and clinical studies as well as supporting validation activities when progressing to late stage.

• PhD in synthetic organic chemistry with 5+ years of experience in pharmaceutical research and development in the biotech or pharma industry, with significant experience in the areas of process development, process characterization, process validation and product life cycle management or BS/MS with 8+ experience is required.
• Demonstrated history working in a virtual CMC development and commercialization environment working with CMC partnerships with global providers.
• Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration a multi-disciplinary business and science team environment is essential.
• Experience with control strategy development by either process characterization or design space studies using DoE or modelling tools.
• First-hand experience in collaborations with medicinal chemistry, analytical, biology, toxicology, clinical pharmacology, Quality Assurance, Regulatory CMC and CMC development departments.
• Must be able to determine appropriate resources for resolution of problems, to have strong organizational and planning skills and work independently.
• Desire to acquire new knowledge in chemistry, pilot and plant operations in different contract research organizations.
• Experience in preparation of CMC documents in support of global regulatory filings across development stages (e.g. IND to NDA).
• Strong computer, scientific, and organization skills.
• Ability to travel ~ 30% both domestically and internationally.