Technical Program Lead

About the Role

This position involves managing post-approval projects, coordinating with multiple departments and stakeholders, and ensuring timely completion of key milestones. The role also includes business development, market intelligence, and strategic planning to support the company’s objectives in the pharmaceutical industry.

Responsibilities

• Define and manage the scope of post-approval projects, including developing and tracking project timelines.
• Set and achieve key milestones throughout the project lifecycle.
• Coordinate with R&D, manufacturing, marketing, and other departments, as well as regulatory bodies and healthcare professionals.
• Provide updates to internal teams and external partners.
• Maintain accurate records of compliance activities, project plans, progress, and outcomes.
• Introduce and track new post-approval projects from cross-functional departments.
• Track existing material inventory and emphasize the importance of post-approval project completion.
• Coordinate with supply chain and procurement for API samples, impurities, and submission batch quantities.
• Track vendor qualification and method validation/verification activities daily.
• Coordinate with cross-functional teams on documentation, specification, method preparation, and revision requirements.
• Track and schedule timelines for material release and drug product.
• Coordinate with operations for submission batch schedules and stability initiation.
• Track post-approval projects through stability completion, filing, and approval.
• Coordinate with Regulatory Affairs and other teams for filing documents and submission timelines.
• Provide confirmation of grant/approval status and implement post-approval projects at commercial scale.
• Provide numerical data on cost-saving or alternate source projects.
• Actively participate in supply chain management and forecast meetings.
• Mentor the Senior Manager of Strategic Portfolio Management on processes and target products aligned with company objectives.
• Work closely with Business Development and Corporate Development to identify and evaluate opportunities for alternate source and cost-saving projects.
• Build financial models to determine value and potential deal structures.
• Conduct due diligence on business development opportunities.
• Collaborate with supply chain, operations, and project management on project timing and projections.
• Assess and provide input on timing, market dynamics, and forecasts for Finance and Tech Ops.
• Analyze products, markets, regulatory issues, companies, and therapeutic categories to drive portfolio and new opportunity decisions.

Requirements

• Bachelor’s degree (BA/BS) in a relevant field (required).
• Master’s degree (MBA) in a relevant field (preferred).
• Minimum of 5 years of pharmaceutical industry experience, with at least 5 years in the generics industry.
• 5 years or more of experience managing people, projects, or a functional area.

Pay

The base salary for this position ranges from $120,000 to $130,000 per year. Additionally, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.

Benefits

Amneal provides a comprehensive, flexible, and competitive benefits program, including:

• Above-market, diverse, and robust health and insurance benefits.
• A significant 401(k) matching contribution to support retirement savings.
• Programs to promote employee well-being, balancing career and personal commitments.