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 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 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.