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Manager, Quality Control Analytical Services
2 months ago
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 (specialists/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. Manage the activities and performance of team to successfully deliver a reliable supply of product, laboratory quality, efficiencies, and improvements, and ensure cGMP compliance. Monitor daily operations and actively assist or provide direction to staff as required. May perform ongoing operational tasks. Act as QC representative on various initiatives, projects, and committees. Apply technical expertise and quality ingenuity to complex issues. Provide input to strategic decisions that affect functional area of responsibility and 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. Perform Budget/CapEx planning, implement cost savings, and ensure 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). Verify and approve data as needed. Provide manufacturing, project/validation studies support. Serve as technical & lead SMEs on projects, programs, committees (e.g. SRB, CSP), and investigations. 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 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. Involved in day-to-day activities where knowledge and expertise provide focus to subordinates. Make decisions based on company and department objectives and allocated resources. 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, projects, committees, and update/planning meetings, providing area perspective and expertise. Manage accountability for meeting requirements.
- Ensure inspection readiness of area/processes. Interface with external regulatory inspectors and internal compliance auditors. May assist with external audits. Ensure timely completion of any commitments made.
- Translate objectives into work plans and guide execution. Leverage data for analysis and recommendations for solutions where possible. Develop and manages operational initiatives to deliver tactical results. Provide management updates on risks and opportunities to ensure desired results are achieved.
- Maintain and demonstrate knowledge of current relevant US and global regulatory requirements/guidelines (e.g. cGMP, FDA, USP/EP/JP+). Update internal procedures to ensure compliance. Extensive knowledge of industry practices for assigned area including specialized functions/technology, concepts, techniques, and standards. Serve as area expert in field within the organization, also leverage other experienced staff SMEs. Effectively communicate and present results and recommendations across discipline.
- Liaison with departments at various management levels regarding operations and projects. Provide direction to team, act on issues, make good and timely decisions that keep the organization moving forward, monitor, and report on progress. Utilize meetings effectively, facilitate/drive team VPM efforts, participate in GEMBA walks, and use Lean/PM tools as appropriate.
- Align own work plans and priorities with those of other units. Balance the need for adequate planning with the need for action. Create realistic timelines with steps outlined in the right sequence. Anticipate and minimize bottlenecks or delays. For example, outline clear plans that put actions in a logical sequence; convey some timeframes. Align own work with relevant workgroups.
- Support team decisions and promote positive morale and team spirit. Involve others appropriately when working on team projects. For example, hold constructive dialogue with the team regularly; take multiple perspectives into account when making decisions. Draw a link between the work and why it matters: share insight into the purpose of the work, involve others appropriately and acknowledge contributions. Celebrate successes.
- Accept needed change despite the uncertainty it brings. Constructively deal with problems that do not have clear solutions or outcomes. Remain calm and productive during transitions or changing circumstances. Work to clarify situations where information, instructions, or objectives are ambiguous. For example, embrace change, stay focused, positive, and effective. Address problems without clear solutions, making substantial progress.
- Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and takes initiative to correct safety & environmental hazards.
- Work individually and as a team with quality and attention to detail. Independent positive leader with strong communication and solid interpersonal skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner.
- Demonstrate & adhere to Lantheus corporate Values. Actively demonstrate quality, accountability, customer service, efficiency, collaboration, and safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
Basic Qualifications
- Requires a BS or MS+ and target 10+ years of related experience & 3+ years management responsibility or equivalent combination of education and work experience. Advanced degree preferred. Degree in a related scientific discipline (e.g. chemistry) and experience in the pharmaceutical industry, related GMP environment, or equivalent preferred.
- This position is site-based in N. Billerica & Bedford MA and requires a presence on-site 3 days per week.
Other Requirements
- Flexibility with scheduling requirements for staff and manager support of them is typically Mon-Fri, but may include evenings, weekends, shifts, and/or holidays. Some non-routine travel may be required.
- Manage and direct staff who must be able to lift/move materials up to 50 lbs, e.g. gas cylinders, bottles of chemicals, lab equipment, etc.
- Manage and direct staff who work with, or in proximity to, potentially hazardous chemical, biological, and/or radioactive materials with proper training. Previous experience preferred.
- Current SME level knowledge of modern industry best practices and procedures for QC labs, and applicable regulatory requirements. SME level knowledge of and previous experience with relevant QC lab software, equipment/qualification, methods/validation, manufacturing processes, budget planning and cost containment, Lean, and project planning/execution preferred.
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.
