Technical Program Lead
Amneal Pharmaceuticals
August 20, 2026
Remote friendly (Piscataway, NJ)
United States
IT
Project Planning and Execution:
- Define and manage the scope of post-approval projects; develop and track project timelines and key milestones.
- Coordinate and track release timelines for material/drug product; coordinate submission batches and stability initiation.
- Track post-approval projects through completion of stability, filing, and approval.
Stakeholder Communication:
- Coordinate with R&D, manufacturing, marketing, supply chain, procurement, operations, and other cross-functional teams.
- Communicate with regulatory bodies, healthcare professionals, and other stakeholders; provide internal/external updates.
- Coordinate with RA and cross-functional teams for filing documents and submission timelines.
Documentation and Record Keeping:
- Maintain accurate records of compliance activities/changes and thorough records of project plans, progress, and outcomes.
Essential Functions:
- Introduce and track new post-approval projects; track inventory and drive completion.
- Coordinate procurement of API samples/impurities and submission batch quantities.
- Track vendor qualification and method validation/verification activities daily.
- Coordinate CFT documentation, specifications, method prep, and revisions.
- Confirm grant/approval status and commercial-scale implementation; provide numerical data on cost-saving/alternate source projects.
Project Selection:
- Participate in supply chain management and forecast meetings; mentor Senior Manager on strategic portfolio processes.
Business Development:
- Identify/evaluate alternate source and cost-saving opportunities; build financial models; conduct due diligence.
Planning/Market Intelligence:
- Support project timing/projections; assess timing/market dynamics impacting forecasts; analyze markets/regulatory issues/therapeutic categories to guide portfolio decisions.
Qualifications:
- Education: Bachelor’s degree in a relevant field (required); Master’s (MBA) in a relevant field (preferred).
- Experience: 5+ years pharmaceutical industry experience with at least 5 years in generics; 5+ years managing people/projects and/or a functional area.
Benefits/Compensation:
- Base salary: $120,000–$130,000/year; short-term incentive/bonus opportunity within first 12 months; 401(k) matching and health/insurance benefits (as described).
Application instructions:
- Contact accommodations@amneal.com for reasonable accommodations during the application/hiring process.
- Define and manage the scope of post-approval projects; develop and track project timelines and key milestones.
- Coordinate and track release timelines for material/drug product; coordinate submission batches and stability initiation.
- Track post-approval projects through completion of stability, filing, and approval.
Stakeholder Communication:
- Coordinate with R&D, manufacturing, marketing, supply chain, procurement, operations, and other cross-functional teams.
- Communicate with regulatory bodies, healthcare professionals, and other stakeholders; provide internal/external updates.
- Coordinate with RA and cross-functional teams for filing documents and submission timelines.
Documentation and Record Keeping:
- Maintain accurate records of compliance activities/changes and thorough records of project plans, progress, and outcomes.
Essential Functions:
- Introduce and track new post-approval projects; track inventory and drive completion.
- Coordinate procurement of API samples/impurities and submission batch quantities.
- Track vendor qualification and method validation/verification activities daily.
- Coordinate CFT documentation, specifications, method prep, and revisions.
- Confirm grant/approval status and commercial-scale implementation; provide numerical data on cost-saving/alternate source projects.
Project Selection:
- Participate in supply chain management and forecast meetings; mentor Senior Manager on strategic portfolio processes.
Business Development:
- Identify/evaluate alternate source and cost-saving opportunities; build financial models; conduct due diligence.
Planning/Market Intelligence:
- Support project timing/projections; assess timing/market dynamics impacting forecasts; analyze markets/regulatory issues/therapeutic categories to guide portfolio decisions.
Qualifications:
- Education: Bachelor’s degree in a relevant field (required); Master’s (MBA) in a relevant field (preferred).
- Experience: 5+ years pharmaceutical industry experience with at least 5 years in generics; 5+ years managing people/projects and/or a functional area.
Benefits/Compensation:
- Base salary: $120,000–$130,000/year; short-term incentive/bonus opportunity within first 12 months; 401(k) matching and health/insurance benefits (as described).
Application instructions:
- Contact accommodations@amneal.com for reasonable accommodations during the application/hiring process.