The organization is seeking a highly qualified candidate to support synthetic-related outsourcing associated with execution of external development, commercial and clinical supply. The position will have a focus in synthetic small molecule drug substance/process chemistry and serve as a key enabling role in a high- performing cross-functional organization. Individual projects may span development, sourcing (e.g., requests for proposal and site selection), supplier onboarding, and manufacturing activities for both non-GMP and GMP commercial / clinical deliverables.The Contract Development and Manufacturing team develops and implements the external sourcing strategy for the firm's portfolio from early phase through commercial delivery. This role will support engagement and oversight of the client's Contract Development and Manufacturing sites through executing activities according to Good Manufacturing Practices (cGMP) principles and the business practices.
Job Responsibilities:
Day-to-day oversight for external synthetic/process chemistry-related projects:
- Overseeing ongoing activities at selected sites along with any subcontracted sites to ensure project deliverables, including compliance, timelines, product quality, and cost
- Working closely with the team and internal stakeholders to support sourcing activities, including managing scope of work (SoW) and quotation request documents
- Coordinating requests for shipment of materials/samples between sites
- Managing purchase orders and invoices
- Overseeing deviations investigations and change managements as needed
- Performing other related duties and tasks as necessary or as assigned
Basic Qualifications:
- Bachelor's Degree & 5 years of Pharmaceutical Industry experience
Preferred Qualifications:
- General knowledge of synthetic drug development and manufacture
- Strong understanding of cGMP and Regulatory/CMC policies and requirements
Experience with interfacing and managing CRO and CMO relationships - Experience with change management, deviation investigations and implementation of corrective/preventive actions
- Understanding of tech transfer, drug development and commercialization of synthetic therapeutics
- Experience working in cross-functional settings
- Experience as a team member or leader of cross-functional or matrix team
- Strong Project management and coordination skills/experiences
- Strong interpersonal relationship and communication skills both written and verbal
Interested candidates may apply through the application system. We regret to inform only shortlisted candidates will be notified.
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