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Director, Manufacturing Science
3 months ago
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, 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.
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.
This Director provides leadership for Lantheus' internal Manufacturing Science and Technology (MSAT) support team, which resides within the Manufacturing Technology and Development (MT&D) organization.
Responsible for leading process support and site validation for finished products, formulation ingredients and components in the field of medical imaging and therapeutics.
Leading a team of engineers and scientists, the incumbent will be accountable for the technology support and transfer processes including planning, process scale-up and development studies, gap assessments, and equipment / process qualification.
Following commercialization of finished products, incumbent is responsible for managing improvement projects and supporting evaluation and resolution of technical and quality issues to ensure supply of commercial products.
Key Responsibilities/Essential Functions
Responsible for managing a team of scientists and engineers to support evaluation and resolution of technical and quality issues to ensure supply of Lantheus' commercial and clinical drug products to customers.
Accountable for the development and management of technical transfer projects internally and to third party contract manufacturing organizations (CMOs) for finished products, formulation ingredients and components.
Establishes project objectives and metrics during qualification, and reports on performance to project metrics.
Drives accountability for project performance and continuous improvement with Lantheus and CMO leadership teams.
Primary liaison with internal team and CMO for technical development, technology transfer, technical modifications and support, and validation studies.
Establishes the appropriate structure (decision making, communication) between external vendors and Lantheus functions during this phase of work.
Collaborate with Procurement and Supply Chain in generating cost and feasibility requests.
Leads cross-functional teams for technical projects, including R&D, Supply Chain, Regulatory, Quality, Finance, Legal and their CMO counterparts (where applicable) to address issues in a timely basis to maintain project plan.
May act in a project manager capacity to drive accountability, action and creative problem solving.
Applies knowledge of advanced scientific disciplines in driving a strong collaboration of Lantheus' Manufacturing, R&D, Regulatory, Quality and MT&D resources with the CMO resources to develop, scale up, transfer and validate commercial-scale manufacturing processes for existing and pipeline products.
Maintains a working knowledge of emerging manufacturing technologies, industry trends, changes in leading pharmaceutical CMOs, etc., particularly as related to sterile injectable products.
Drives continuous improvement projects with established project metrics. Ensures projects are managed within budget, leads budget process, prioritizes and drives cost saving initiatives.
Provides technical information and draft regulatory submissions to Regulatory Affairs to support project closure as required.
Leads and manages technical team including establishing appropriate project-related goals and objectives for staff as well as personal development plans.
Actively promotes safety rules and awareness.
Demonstrates good safety practices at all times including the appropriate use of protective equipment.
Reports and takes initiative to correct safety and environmental hazards.
Actively demonstrates Lantheus' values.
Typical Minimum Skills and Experience and Education
Requirements include a B.S. or M.S. in relevant technical discipline, Ph.D. preferred.
15+ years of experience in the areas of parenteral manufacturing process development, equipment/process validation and technical transfer.
Previous experience working with aseptically filled drug products, radiopharmaceuticals and CMOs strongly preferred.
Other Requirements
Ability to work in a prompt, complex and changing environment.
Ability to function autonomously, with an appreciation of detail while being cognizant of "the big picture".
Strong mentor, with excellent people development skills and track record.
Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills.
Prior experience in leading and managing interdisciplinary or cross functional pharmaceutical or biotech teams is required.
Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is highly desired.
Must be able to devise program goals and objectives and align those goals with technical staff and effectively communicate those objectives with internal teams and external vendors.
Project management experience is necessary to ensure plans are developed to mitigate technical and logistical issues, to keep programs on their agreed upon timelines.
Proven ability to drive performance, collaborate and resolve technical issues are critical skills.
Knowledge of regulatory, process development and validation requirements are important to ensure compliance.
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.
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