Technical Program Lead

Amneal

About The Position

The Technical Program Lead will be responsible for defining and managing the scope of post-approval projects, developing and tracking project timelines, and ensuring timely completion with key milestones. This role involves coordinating with various departments such as R&D, manufacturing, and marketing, as well as communicating with regulatory bodies and healthcare professionals. The position requires maintaining accurate records of compliance activities, project plans, progress, and outcomes. Key functions include introducing and tracking new post-approval projects, managing existing material inventory, coordinating procurement of API samples and submission batches, tracking vendor qualification and method validation, coordinating with cross-functional teams (CFTs) on documentation and specifications, scheduling material and drug product release timelines, coordinating submission batch schedules and stability initiation with operations, tracking post-approval projects through completion, coordinating with RA and other CFTs for filing documents, confirming grant/approval status and implementation at commercial scale, and providing data on cost-saving projects. The role also involves participating in supply chain management and forecast meetings, mentoring the Senior Manager of Strategic Portfolio Management, identifying and evaluating opportunities for alternate sources and cost-saving projects with Business Development, building financial models, conducting due diligence, and collaborating with supply chain, Operations, and Project Management on project timing and projections. Additionally, the role requires analyzing products, markets, regulatory issues, and companies to inform portfolio decisions and new opportunities.

Requirements

Bachelors Degree (BA/BS) in a Relevant Field
Minimum of 5 years of pharmaceutical industry experience
At least 5 years in the generics industry
5 years required managing people, projects, a functional area or a combination of the above.

Nice To Haves

Master Degree (MBA) in a Relevant Field

Responsibilities

Define and manage the scope of post-approval projects.
Develop and track project timelines to ensure timely completion.
Set and achieve key milestones throughout the project lifecycle.
Coordinate with R&D, manufacturing, marketing, and other departments.
Communicate with regulatory bodies, healthcare professionals, and other stakeholders.
Provide updates to internal teams and external partners.
Maintain accurate records of compliance activities and changes.
Keep thorough records of project plans, progress, and outcomes.
Introduce and track new post-approval projects when received from SSSM or other cross-functional departments.
Track existing material inventory and highlight the importance of post-approval project completion.
Coordinate with supply chain and procurement department for procurement of API samples, impurities and submission batch qty.
Track vendor qualification and Method Validation and Verification activities on daily basis.
Coordinate with CFT’s on documentation, specification, method preparation and revision requirements.
Track and schedule the timeline for release of the material and drug product.
Coordinate with operations for the submission batch schedule and stability initiation.
Track post-approval project throughout the completion of stability, filing and approval.
Coordinate with RA and other CFTs for required filing documents and submission timeline.
Provide confirmation of grant/approval status and implementation of post-approval project at commercial scale.
Provide numerical data on cost-saving/alternate source projects.
Actively participate in the supply chain management and forecast meetings.
Mentor Senior Manager of Strategic Portfolio Management on the process and target products consistent with the company’s strategic objectives and based on knowledge of Brand and Generic pharmaceutical markets.
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 BD opportunities.
Work closely with supply chain management, Operations, and Project Management on project timing and projections to ensure a smooth and effective completion of projects from either internal or external facilities.
Assess and provide critical input on timing, market dynamics, etc. that drive near- and long-term forecasts for Finance and Tech Ops.
Analyze products, markets, regulatory issues, companies, therapeutic categories, etc. to drive decisions on portfolio and new opportunities.