Client: large biotech
Location: 100% remote from anywhere in the US
Duration: 12 month
Rate: 40-45 per hour W2
The Client Contract Development and Manufacturing (ACDM) organization is seeking a highly qualified candidate to support synthetic-related outsourcing associated with execution of external development, commercial and clinical supply of drug substance (DS). The position will be focused on 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, manufacturing, and continuous improvement activities for both non-GMP and GMP commercial / clinical deliverables.
The Client Contract Development and Manufacturing team develops and implements the external sourcing strategy for Client’s portfolio from early phase through commercial delivery. This role will support engagement and oversight of Client Contract Development and Manufacturing sites through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices.
Job Responsibilities:
Day-to-day oversight for external synthetic/process chemistry-related projects:
- Overseeing and supporting 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 ACDM team, Process Development, External Quality, Supply Chain, and other 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, invoices, and project-related budget
- Overseeing deviations investigations and change managements as needed
- Maintain and update business related trackers as needed
- Support continuous improvement projects and operational excellence within ACDM
- Performing other related duties and tasks as necessary or as assigned
Basic Qualifications:
Bachelor's Degree in Engineering, Chemistry, or Science-related field
4+ years of Manufacturing or Operations experience
Preferred Qualifications:
- Knowledge of synthetic drug development and manufacture
- Experience in Project Management
- Understanding of cGMP, Operations and Regulatory/CMC policies and requirements, especially in the Pharmaceutical Industry
- Experience with interfacing and managing CRO and CDMO 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, as part of cross-functional team or matrix team
- Strong interpersonal relationship and communication skills both written and verbal
Basic Qualification:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
