CMC Project Manager

Description

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

In 2023, Lantheus had more than $1B in revenues, led by sales of imaging agents for cardiac ultrasound and for prostate cancer.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.

At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.

Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands.

We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of role

This position will be responsible for providing CMC Project / Program Management expertise and support to ensure project milestones and deliverables are met, and that Lantheus' product transfer (inclusive of finished drug product or critical raw materials) program activities are well executed and managed.

Responsibilities include leading and partnering with internal team members, stakeholders as well as external partners to create and manage implementation plans in alignment with the strategic CMC Technical Transfer and Business Development Plans and estimated budgets.

This includes providing the operational leadership to cross-functional teams and driving the day-to-day planning, coordinating, and tracking of critical activities.

The Sr. Project Manager will be responsible for creating / maintaining the project timelines to keep the project on schedule for regulatory submission and commercial activities.

Key Responsibilities / Essential Functions

• Partners with both internal and external partners to optimize team effectiveness and decision making. Works with the Tech Ops Leadership Team and cross-functional teams to develop a detailed project plan and associated budget for technical transfer commercialization program(s).
• Creates and drives timelines to keep program(s) on schedule. Prepares program timelines (Gantt chart) identifying all significant activities, dependencies, resources, milestones, and key success factors.

Assists the Program Leadership Team in planning, coordinating, and tracking cross-functional and external activities for Lantheus' drug product commercialization program(s).

Continual review and analysis of critical path activities.

Facilitates highly effective team building and communication. Works with external partners and the Leadership Team and cross-functional teams to develop and distribute agendas for regular team meetings.

Helps facilitate meetings and keeps them on track. Provides meeting minutes and drives follow up on Action Items. Proactively, and independently, identifies and resolves program team challenges.

• Performs effective risk management assessments with the Cross-functional Teams, the Leadership Team, and stakeholders.
• Drives information flow and communicates program status to all stakeholders in collaboration with the Program Leadership Team.

Produces regular status reports (milestones, status, issues, decisions), following review by the Program Leadership Team and Cross-functional Teams, for senior management.

• Reviews and proposes revised program work plans to accommodate changes in technical, marketing, or business objectives.
• Consolidates and reports on program budget. Works with the team and functional areas to prepare the quarterly (and longer range) program budget.

Provides budget forecasts as requested.

• In cooperation with functional managers, ensures that resources assigned to the program are adequate to meet program objectives and identifies resource constraints.
• Maintains effective communication with the program team through oral and written correspondence and ensures adequate documentation of each communication.
• Creates and maintains an appropriate electronic platform for reporting and documentation of relevant program information, records, etc.
• Prepares information with appropriate input from program team members for internal as well as external partner review / governance meetings.
• Interfaces internally by acting as a liaison and facilitator of cross functional teams (ie, Clinical Development, Clinical Operations, Technical Operations, R&D, Regulatory, Quality Assurance, Finance, etc.

in planning and executing regulatory submission and product commercialization.

• Interfaces externally with collaborators, vendors, contractors, and consultants to ensure communication and deliverables in accordance with planned program objectives.
• Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment.

Reports and takes initiative to correct safety and environmental hazards.

Actively demonstrates Lantheus' values.

Basic Qualifications

• Requirements include a B.S. or M.S. in relevant scientific / technical disciplines.
• 10+ years of work experience within pharmaceutical or medical device industry, 5+ years of Program / Project Management experience, within a matrixed pharmaceutical, medical device, or biotechnology organization.

PM Certification is a plus.

Previous experience working with aseptically filled drug products, medical device, radiopharmaceuticals and CMO management strongly preferred.

Other Requirements

• Proactive mindset with strong leadership, facilitation, teamwork, and influence management / negotiation skills.
• Excellent verbal and written communication skills as well as exceptional organizational capability.
• Prior experience in leading and managing interdisciplinary or cross functional pharmaceutical or biotech teams is required.
• Ability to drive program plans and timelines (across multiple functional areas) is essential. Proven success in goal setting, prioritization and time management is required.
• Understanding of FDA and / or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired.
• Experience working with external partners is highly desirable.
• Experience actively participating in a steering committee or joint development committee for pharmaceutical, biotech, or medical device product development is highly desired.
• Ability to work independently in decision-making and resolution of program obstacles and conflicts.
• Familiarity with developing budgets and forecasting is highly desirable.
• Keen insight, independent judgment and tactful discretion are required.
• Must be able to demonstrate strong analytical and problem-solving capabilities.
• Ability to function autonomously, with an appreciation of detail while being cognizant of "the big picture".
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Lantheus to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism.
• Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Lantheus and CMO locations.

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Lantheus is an E-Verify Employer in the United States.