Sr. Principal Project Manager - API Manufacturing

Hispanic Alliance for Career Enhancement; Lebanon (IN); On-site; USD 76,000 - 168,000; Full time

Job summary

Join a forward-thinking company in the healthcare sector as a CMC Project Management Professional. This role offers an exciting opportunity to lead pharmaceutical manufacturing projects at a new facility in Lebanon, IN. You will oversee critical CMC activities, ensuring compliance with GMP standards while collaborating with cross-functional teams. Your expertise in project management and pharmaceutical processes will be vital in navigating challenges and implementing effective solutions. With a commitment to diversity and inclusion, this innovative firm values your contributions and supports your professional growth. Embrace the chance to make a significant impact in a dynamic environment focused on improving lives globally.

Benefits

401(k)

Health Benefits

Paid Time Off

Well-being Programs

Bonus Potential

Qualifications

• 5+ years' experience in pharmaceutical manufacturing and project management.
• Strong background in GMP compliance and facility startups.

Responsibilities

• Oversee CMC activities and manage pharmaceutical manufacturing projects.
• Coordinate new facility start-up activities and ensure GMP compliance.

Skills

Project Management

GMP Compliance

Pharmaceutical Manufacturing

Risk Management

Leadership Skills

Education

Bachelor's degree in a scientific field

PMP Certification

MBA

Tools

Project Management Tools

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back to communities through philanthropy and volunteerism. We prioritize people and strive to make a positive impact globally.

Lilly is constructing an advanced manufacturing facility for API production in Lebanon, IN (Lilly Lebanon API). This greenfield site represents Lilly's largest investment in manufacturing capacity, supporting current and future products, including new modalities. This role offers a unique opportunity to join the startup team, helping to establish processes and facilities for successful GMP manufacturing operations.

Position Description:

The CMC Project Management Professional oversees the Chemistry, Manufacturing, and Controls (CMC) activities for our pharmaceutical products. This role requires a strong background in managing pharmaceutical projects and new facility startups, ensuring GMP compliance. Responsibilities include developing and implementing integrated CMC plans from portfolio entry to global submissions and launch. The ideal candidate will have product manufacturing knowledge, leadership skills, and the ability to influence across functions and leadership levels. A background in CMC or manufacturing is essential, with application of project management principles such as those outlined in PMBOK, including risk management for cross-functional teams.

Key Objectives/Deliverables:

• Manage pharmaceutical manufacturing projects, facilitate reviews, and lead teams to ensure timely project delivery.
• Handle project schedules for tech transfer, process validation, and commercialization of APIs.
• Coordinate new facility start-up activities, including validation processes.
• Collaborate with SMEs across various functions to manage project changes.
• Maintain technical knowledge relevant to projects.
• Implement and improve business processes like capacity and budget planning, resource forecasting, and tracking.
• Identify operational challenges and develop solutions, ensuring project management involvement in process improvements.
• Ensure all CMC activities adhere to GMP standards, maintaining quality and safety.

Project Management Expertise:

• Use project management tools and influence decision-making at all levels.
• Navigate ambiguity and connect project dots effectively.
• Develop risk management strategies and contingency plans.
• Evaluate project impacts of new requests and manage change controls.
• Lead operational planning and data evaluation for new projects.

Basic Requirements:

• Bachelor's degree in a scientific, engineering, or related field.
• At least 3 years' experience with project management tools and processes.
• Minimum 5 years' pharmaceutical experience in relevant areas like drug discovery, CMC, or manufacturing.

Preferences:

• Experience in operations, QA/QC, regulatory, or supply chain within pharma manufacturing.
• Green Belt or Black Belt certification, technical transfer experience.
• Advanced degrees or certifications such as PMP, PE, or MBA.
• Proven leadership in cross-functional teams and problem-solving skills.
• Excellent communication and organizational skills.

Lilly is committed to diversity and inclusion. We support individuals with disabilities and provide accommodations during the application process. For assistance, complete the workplace accommodation request form.

We are an equal opportunity employer, valuing diversity and inclusion across all protected classes.

Our employee resource groups include networks for various communities and interests, fostering support and engagement.

Compensation varies based on education, experience, and location, with an expected range of $76,500 - $167,200. Benefits include a bonus potential, 401(k), health benefits, paid time off, and well-being programs. Lilly reserves the right to modify these programs as needed.