Associate Director, Quality Control Analytical Services & Technology

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. 

Summary of role

We are seeking a strong experienced Subject Matter Expert (SME) candidate to:

Lead a high performing team of Quality Control laboratory technical staff (scientists) that are responsible for Laboratory information Management System (LIMS), Chromatography Data Systems (CDS), lab equipment qualifications, and projects, and demonstrate a commitment to Quality goals and initiatives. Drive the activities and performance of team to successfully deliver a reliable supply of product, laboratory quality, efficiencies, and improvements, and ensure cGMP compliance. Responsible for planning, advise on priorities and technical issues; actively assist as required. Act as QC representative on various initiatives, projects, and committees. Apply technical expertise and quality ingenuity to complex issues. Provide input to aligned strategic direction for QC area, support change initiatives, draw from experience and expertise to make appropriate decisions that result in achieving objectives to positively impact our modern integrated lab vision.

Area Specific Information

• Responsible for all aspects of the department operation, e.g., effective hiring, training/cross-training, schedule, compliance, and safety. Ensure lab equipment is qualified, and methods are current and validated/verified. Work with lab management to ensure that QC testing, recording, collection, review/approval and maintenance of data, are performed in accordance with SOPs, cGMPs, company standards, policies and regulatory requirements. Manage individual and group performance to meet internal policies and requirements, ensuring work is performed in a quality, compliant, and timely manner and meets business priorities/objectives. Requires flexibility to accommodate changes and priorities. Monitor and report metrics and trends. Responsible for Budget/CapEx planning, implementing cost savings, and ensuring expenditures are aligned.
• Oversee QC Tech Group: Responsible for LIMs and CDS administration, efficiency/use improvements (working with IT/labs), and troubleshooting. Perform equipment qualifications/ troubleshooting/ decommissioning, method improvements/ validations (lead by MAD), Quality Validation Assessments (QVAs). Support other QC department testing of incoming materials, solutions, in-process, finished products, and stability studies. Write annual invalids assessment report, assesses OOA/OOTs (working with statistician). Create/review protocols and reports, verify and approve date as needed. Provide manufacturing, project/validation studies support. Serve as technical & lead SMEs on projects, programs, committees (e.g. SRB, CSP), investigations and change controls. SMEs for inspections/audits. QC Tech Group supports QC teams cross-functionally, and works regularly with other Quality teams, Tech Ops, IT, Regulatory and more.
• Expert experience with analytical methods and equipment such as HPLC, GC, AA, FTIR, UV, KF (titration), Polarographic Analyzer, Polarimeter, DSC, O2 Headspace, radioactivity detectors & dose calibrator; wet chemistry (compendial+) testing.

Key Responsibilities/Essential Functions

• Manage activities of team. Helps to develop and implement new projects and procedures for department to meet goals. Provide input to strategic decisions that affect functional area of responsibility. Manage work efforts and individual contributors. Make decisions based on company and department objectives and allocated resources, support change initiatives. Role model values and corporate culture.
• Ensure appropriate & timely use of a wide range of electronic systems such as LIMS, CDS, QMS, ERP and equipment software. SOP business owner, administrator for area-specific software systems, lead investigations.
• Represent Quality Control and/or area department(s) on a range of initiatives, pr