This role provides leadership, direction, and Quality Assurance (QA) oversight of contract manufacturers (CMOs) and service providers for cell bank, drug substance (DS), drug product (DP), packaging and labeling, and distribution of multiple products. The Sr. Director collaborates closely with CMC, Quality Compliance and Analytical Development colleagues to ensure compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations, and ensures staff execute within the company’s Quality Management System.
Serves as Global Safety Lead and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team and Safety Management Team for assigned compounds and products. Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product. Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products. Manages cross-functional assessment of benefit-risk profile and communication of safety information.
The Associate Scientific Director provides medical and scientific strategic and operational input into core medical affairs activities such as health care professional and provider interactions. This role involves generating clinical and scientific data, educational initiatives, and safeguarding patient safety. The director works closely with commercial teams to provide strategic medical input into core brand strategies and to support medical and marketing activities and market access.
Amylyx is seeking an Associate Director, Drug Substance to join the CMC and External Manufacturing team, serving as the technical development drug substance owner for Avexitide and AMX-0114. This role involves working with external CDMOs to develop, scale-up, and validate drug substance processes, contributing directly to asset CMC teams and reporting to the Senior Vice President, Global CMC and External Manufacturing.
We are seeking an Associate Director responsible for phase-appropriate small molecule drug substance development who will bring a strong process development background and experience managing external vendors, and will define and execute on a strategy for synthetic route, process optimization, site transfer, scale-up and validation.
Prepare prior authorization requests by validating prescriber and member information. Make outbound calls to providers to obtain clinical information for pharmacist review. Proactively obtain clinical information from prescribers. Triage phone calls from members, pharmacy personnel, and providers by asking clinical questions. Effectively communicate issues and resolutions to stakeholders and follow HIPAA guidelines.