Reporting directly to the President/CEO, the ideal candidate will provide support to the company's manufacturing and R&D operations.  The Director is responsible for the development, management and oversight of short and long term Quality strategy as it relates to internal and external manufacturing. This includes assuring continuous compliance to relevant domestic and international cGMP requirements, effective risk management, assuring collaboration between QA/QC and Customer Service, R&D and Mfg and Supply Chain.  Position leads a staff of approximately 60 people.  The Quality organization is responsible for internal and external audits, investigations, batch record review and release, customer complaint program.  SOP's, change control, approval of validation protocols and reports.  Quality Agreements, Quality Systems, environmental monitoring, sampling of incoming materials, and laboratory testing (chemistry, microbiology, physical, radiometrics).  Minimum requirements include a bachelor's degree in a scientific discipline, 15 years experience in QA/QC in the pharmaceutical industry, and 5 years direct staff management experience. Occasional travel required.

Reporting to the Vice President of Global Research and Development, the ideal candidate will be responsible for developing regulatory strategy for new product development and registration, as well as life cycle management of marketed products.  Also responsible for managing the strategy and execution of interactions with FDA and health authorities in Europe, Canada, and Asia Pacific through leadership of a small US-based regulatory team and in-country contract resources in international regions.  Minimum requirements include BS degree, 10-15 years experience in managing regulatory process and registration aspects of the drug development process and/or regulatory drug commercialization activities, and experience managing and developing people to succeed in a fast-paced, rapidly changing regulatory environment.

Reporting to the Director of Finance, the ideal candidate will be responsible for tax planning, reporting and compliance, as well as coordination with external tax advisors.. This individual must facilitate decision making in all of these areas to help ensure the continued growth and compliance of the Company.  Minimum requirements include bachelor’s degree in accounting, CPA, 10-15 years of tax planning, reporting, and compliance experience, and public company experience.

Reporting to the VP of Human Resources, the incumbent will provide strategic and tactical support to all business units directly and through an HR Business Partner.  Will coach and advise managers and employees on matters relating to organizational and individual performance, change management, compensation, employee relations, recruitment and retention, training, regulatory compliance and more.  Will also play a significant role in developing and executing strategic HR plans.  Minimum requirements include 15 years progressive HR generalist experience with significant experience working with senior management.  A mix of large and small company experience is helpful as well as biotech and/or pharma experience.

Reporting to the Manager of Capital Project Management, the ideal candidate will work independently to lead the planning, scheduling, control and effective coordination of all parallel activities related to the management of multiple projects of moderate to high complexity from concept through close-out. In particular, this position will require the ideal candidate to:

• use project planning tools and management principles to initiate, design, develop, and evaluate plans for own projects and hold projects on schedule coordinating parallel activities.   Provide project management reports and presentations.
• Manage, coordinate and oversee development of project design documents. Select AE firms to perform engineering design. Coordinate and lead team review of designs/deliverables and document decisions.
• Prepare project estimates for design, equipment, installation, labor, materials, and other related costs. Work with Purchasing to prepare bid packages for design and construction contracts.
• Achieve effective financial control through management of project scope, estimating, risk management, and project closeout.  Negotiate with contractors and suppliers to keep projects within budget while obtaining excellent value.
• Demonstrate a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures. Incorporate into all assigned projects.
• Incorporate safety in all aspects of projects; construction safety management, site security, environmental control, hazardous materials management, fire protection and life safety systems.
• Manage and oversee project contract work. Review and approve contractor bids, RFI’s, submittals and change requests. Inspect or direct the inspection of work to ensure conformance to design drawings, specifications, schedules, and safety regulations. Ensure contractors receive site orientation and training and that all state/local code requirements and building permit, inspection and project close-out processes are followed.
• Achieve high customer satisfaction through effective communication of both technical and non-technical topics with all levels of the organization both verbally and in writing.   Exhibit project leadership, self-confidence and effective decision-making throughout each project and consistently deliver projects that meet all stakeholder requirements and are fully commissioned, qualified and ready for start-up / occupancy.

The ideal candidate will supervise stability testing, including the testing of raw materials, in-process materials, and finished products in a timely and compliant manner.  The candidate will also ensure the integrity and quality of data generated and that the analysts are meeting all cGMP and safety requirements.  Responsible for laboratory operations, including calibration, qualification, and maintenance of laboratory equipment and ensuring that lab supplies are available.  Major responsibilities include:

• Supervising day-to-day operations of the QC Chemistry laboratory including scheduling of laboratory personnel, monitoring workload for weekday operations, training and mentoring staff, and enforcing company safety and personnel policies.
• Ensuring that product testing is performed per established SOP’s and that collection and maintenance of data are performed in accordance with cGMP’s, Lantheus standards and policies, and other regulatory requirements.
• Participating in continuous review/upgrade of product testing functions and ensuring methods are current and validated to achieve a high performing, efficient and flexible work environment.
• Interfacing with external regulatory inspectors from FDA, EMEA, etc. and internal compliance auditors during in-plant inspections.  Ensuring timely completion of any corrective and preventive actions (CAPA) made.
• Providing a strong Quality commitment by maintaining a thorough knowledge of current and emerging US and international guidelines (FDA, USP, cGMP).
• Participating in staffing decisions to ensure that there are adequate lab resources to meet business needs.
• Writing/reviewing investigational reports, SOPs, and validation protocols/reports ensuring timely resolution/tracking of Quality Events (deviations, investigations, CAPAs).
• Participating in the budgeting process, ensuring lab expenditures are in line.

Requirements include a Bachelor’s degree in a scientific discipline (or related field), five years working experience in a pharmaceutical or related environment and experience writing protocols, procedures, reports, and investigations.  Must have broad knowledge of cGMPs and laboratory compliance requirements.  Knowledge of data analysis with appropriate statistical evaluation and trending required.  Ability to lead and direct work of others as well as ability to respond to ever changing priorities.  Must be detail oriented with the ability to multi-task, be a strong team player, and be able to collaborate with all levels of management.  Familiarity with electronic tools (LIMS, COSMOS, trackwise, QETS, etc.) is necessary.

The ideal candidate will: Authorize formal Quality release of drug products, materials and components; Provide technical and regulatory (cGMP) review of all production documentation and test data for completeness and accuracy; Review stability test data to ensure highest quality standards are met throughout the product shelf-life; and make appropriate decisions to ensure the highest quality standards are met when the product is released. 

• Responsible for disposition of marketed radioactive finished product, raw materials, components and in-process materials consistent with LMI quality standards, current specifications and standard control procedures, including manufacturing, testing, labeling and packaging components and operations.
• Recognize potential causes of aberrant results.  Review deviations and discrepancies and ensure resolution prior to release.  Demonstrate a creative approach to problem solving with a clear willingness to take accountability for results.  Immediately report to supervision any incidents that may require corrective action to ensure timely resolution.
• Assist in quality investigations or issues related to products and processes.  Identify root causes.  Implement corrective actions.
• Comply with the release dates for all products and professionally resolve issues allowing timely shipment of product to meet market demands.  Function independently but seek guidance from more senior technical resources or management when resolving complex non-routine issues.
• Support the Stability Program and Annual Product Review including thorough review and organization of LIMS data and trend analysis.  Write and edit various sections of reports as appropriate.
• Possess an understanding/knowledge of LMI systems and regulatory requirements and their application to electronic records, good documentation practices, batch record review, etc.
• Ensure daily activities comply with all cGMP and Safety regulations.
• Interface with internal and external auditors (compliance, customers, and regulatory agencies) during in-plant inspections relating to release, ADP and stability issues.
• Exercise a high degree of flexibility and open-mindedness in dealing with an ambiguous and complex work environment.  Balance multiple demands and goals in a responsive, professional manner.
• Understand end-use implications of product properties: labeling, purity, efficacy, sterility and stability.  Make appropriate decisions to ensure the highest quality standards are met when the product is released.
• Participate in continuous review and upgrade of stability and release processes to achieve a high performing, efficient and flexible work environment.
• Prepare Certificates of Analysis (COA’s) and Certificate of Compliance (COC’s) as required for release of radioactive products.
• Provide coverage on off-hours.

Requirements include a Bachelors of Science degree in related field and a minimum of three years experience in the pharmaceutical manufacturing and/or quality environment.  Experience reviewing and evaluating test results.  Knowledge of manufacturing processes within the pharmaceutical industry.  Demonstrated ability to self-manage in order to achieve tight deadlines.  Knowledge of various electronic Quality systems such as: GxPharma (documentation), CATSWeb (CAPA) and LIMS (stability/release).  Demonstrated ability to work and communicate effectively with a variety of individuals, teams and cross-functional groups in a complex, changing and diverse environment.  Strong cGMP skills and ability to participate in investigations impacting product release/APR/stability issues.

The ideal candidate will provide technical support on all HVAC equipment and systems design, installation, repair, maintenance, commissioning, qualification, and validation projects.  The Facility/HVAC Engineer will ensure optimization of existing equipment and systems efficiencies by performing efficiency evaluations on all types of heating, ventilating, and air conditioning equipment and implementing recommendations.  The Facility/HVAC Engineer aids in providing day to day direction to the hourly maintenance employees and contractors on all aspects of maintenance work throughout the plant, including the maintenance, repair and upkeep of plant equipment, infrastructure, and utilities.  Will work closely with RCM Engineer, Environmental Health and Safety, Engineering, Manufacturing, Building Landlords, and Quality Staff to realize organizational objectives.  Develops and maintains operational SOPs, predictive and preventive maintenance job plans and PMs.  Collaborates with peers to develop HVAC standards for equipment, materials, sequence of operations, and design.  Identifies root cause of failures and implements long term solutions.  Takes appropriate actions to correct plant engineering and maintenance issues as they occur.  Responsible for supporting departmental vision that will provide for continuous improvement in all aspects of the organization. 

Reporting to the Head of Medical Affairs and Pharmacovigilance, the Medical Director (MDIR) of global pharmacovigilance will manage all global pharmacovigilance activities and safety reporting for all marketed products. The MDIR will be responsible for managing in house and external contractors, including global CRO(s). The MDIR will be responsible for ensuring that GPV processes receive, collect, analyze, follow-up and report all individual adverse events, according to local and international regulatory requirements, according to Lantheus Medical Imaging SOPs, and according to good industry practices. The MDIR will be responsible for drafting new SOPs as needed and presenting these to the SOP review committee in a timely manner, and for appropriate training and documentation of pharmacovigilance staff accordingly. The MDIR will be responsible for the oversight management of our global CRO pharmacovigilance partner and associated staff, and for ensuring the training, education and performance of these contract staff, as well as in house staff. The MDIR will be responsible for the timely preparation and oversight of the reporting of events to regulators, and for the oversight and review of aggregate summaries and periodic reports (e.g. annual IND updates, PSURs etc.) of summary data. The MDIR will be responsible for developing and implementing a risk management plan for all products in accordance with regulatory needs. The MDIR will also supervise and be responsible for the aggregation of data for safety signal detection, for its analysis and their appropriate reporting.

The MDIR will work closely with and manage the Medical Research Associate(s) in pharmacovigilance. The MDIR will work with and align activities with the Medical Information group and the Medical Affairs Field Organization (MAFO) within Global Medical Affairs, as well as cross-departmentally with key stakeholders in Regulatory Affairs, R&D, and Marketing. The MDIR will also play a prominent role in communication of the safety profile in aggregate and in individual cases to the external physician and health care provider communities. The MDIR will collaborate with Pre-clinical and with Clinical R&D as needed to better assess and understand the safety profile of marketed products, and in the preparation of safety surveillance activities for pre-market products.