PET Supplier Quality Manager-CMC

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.

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

We are seeking a quality manager to proactively support Chemistry, Manufacturing & Controls (CMC) aspects for the PET Supplier Quality Team. Ideal candidates are experienced in CMC authoring and will manage the process and perform authoring tasks for CMC regulatory documents including module 3 CMC submissions, technical reports, and SOPs. Other job responsibilities include supporting the PET Supplier Quality team with auditing, data collection, and QMS activities.

Key Responsibilities/Essential Functions

Duties and Responsibilities:

• Author and review CMC sections of regulatory filings for radiopharmaceuticals.
• Collaborate with technical subject matter experts including analytical, drug substance and drug product development to review, interpret data and author technical reports.
• Serve as CMC representative on core projects, manage project activities, assess risks and develop plans to develop strategies for programs in accordance with regulatory, scientific, and technical criteria.
• Maintain submission information in relevant CMC systems, track timelines for specific projects/products.
• Serve as a technical and scientific resource and provide guidance for completion of difficult and complex projects.
• Prioritize and independently complete assigned workload appropriately.
• Manage and contribute to CMC-related projects, initiatives and actions.
• Summarize scientific information from development reports and identify details relevant to support regulatory submissions.
• Conduct audits of external suppliers.

• Actively demonstrate the Lantheus values of accountability, quality, customer service, efficiency, collaboration and safety.
• Travel expectation: 10-20%.
• This position is site-based and requires a presence on-site three days per week.

Basic Qualifications:

• Bachelor's degree is required in a related science discipline.
• Minimum of 5+ years quality assurance/technical experience in a pharmaceutical/life-science environment, or 3+ years with a Masters degree.
• 2 years working in the pharmaceutical industry, and strong experience authoring CMC regulatory sections (including INDs/ CTAs).
• Demonstrated ability to translate complex information from various technical documents into written source reports supporting filing.
• Familiarity with regulatory health authority expectations for CMC (Module 3) pharmaceutical applications.

• Working knowledge of PET Good Manufacturing Practice guidance and FDA regulations regarding the manufacturing of PET drugs is preferred.

• Excellent written and verbal communication skills.
• Exceptional influencing, partnership, and collaboration skills.
• Experienced with eCTD structure and subsections.
• Proficient with Microsoft Office applications.
• Excellent oral and written skills.
• Teamwork and collaboration skills.
• Strong attention to detail.

Other Requirements (preferred):

• Knowledge of US cGMP, ICH requirements, ISO9001, US regulatory regulations.
• Experienced in Positron emission tomography (PET) manufacturing and aseptic manufacturing, including strong technical understanding of aseptic manufacturing processes, equipment and facilities requirements.

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. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.

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