Senior Scientist II PET Analytical Development

Position Summary: Operates with a high degree of independence and is adept at conceptually outlining development, qualification, and life-cycle management studies with a focus on process analytical concepts to monitor and control critical steps in the manufacturing process of radiopharmaceuticals, ensuring consistent quality and safety meet current regulatory requirements on radiopharmaceutical drug products. Drives development and validation of new and improved radiochemical process controls in commercial processes; implements analytical methods and/or physicochemical characterizations in support of process development; radiolabeling processes and detection; and/or technology transfer to Contract Organizations. These efforts support the economical, efficient, and safe manufacture of radiolabeled precursors, bulk drug substances, and/or drug products. Lead PET CMO analytical operations and execution from late-stage development through site qualification. Engages in the development of complex strategies and testing requiring implementation of sophisticated, specialized scientific knowledge and advanced lab techniques, with latitude for independent judgment, decisions, and action. Radiopharmaceutical experience is preferred.

Essential Functions: Plans and drives multiple projects, requiring initiative and innovation, within Lantheus Quality system and governing regulations. Works on complex problems of diverse scope while serving as a technical analytical SME. Identifies, analyzes, and interprets project results. Evaluates results and examines implications to program. Participate in technical troubleshooting sessions for processes and products manufactured in-house and at CMOs as needed and in investigating atypical/OOS results. Performs routine laboratory, including working with radioactive materials, or oversees these actions at PET CMOs. Demonstrates ability to follow SOPs and Lantheus procedures as written. Tracks laboratory supplies and replenishes when needed. Maintains laboratory notebook, record keeping, and laboratory safety in accordance to common industry GLPs and Lantheus, or CMO site, procedures. Exhibits an increased understanding of radiochemistry, its regulations, stays aware of new scientific developments, and is able to incorporate these into their development/qualification activities. Communicates scientific ideas and information in an appropriate and timely manner. Employs active listening skills to maintain clear communication to others. Provides technical support to further program and Qualification activities at CMO/CROs; Authors technical transfer protocols and ensure acquired results are collected and documented according to cGMPs; Assists in completion of close-out reports and appropriate Change Controls. Shows the ability and willingness to continually enhance functional and technical expertise. Assesses own strengths/ needs and learns from experience and feedback in order to continually enhance the level of functional and technical expertise. Takes action on developmental opportunities. Accurately documents results in established formats. Able to write basic reports clearly and succinctly. Prepares written reports on all phases of laboratory and/or field experimental work. Presents results to colleagues at scientific meetings and to multidisciplinary audiences in program meetings. Writes comprehensive reports based on literature, lab and field data. Maintains current knowledge of, and ensure all work activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures. Follows procedures to support intellectual property protection. May be responsible for preparing and defending patent disclosures and applications. Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards. Actively demonstrates the Lantheus values of Helping people be their best; Respect one another and act as one; Learn, adapt, and win; Know someone's health is in our hands; and Own the solution and make it happen.

Typical Minimum Skills and Experience and Education: Degree in Chemistry, Engineering, or related discipline or equivalent relevant industry experience. Requires a minimum of a Ph.D. degree and 5+ years relevant industry work experience or a M.S. degree and 8+ years relevant work experience or a B.S. degree and 10+ years relevant industry work experience. Scientific knowledge and experience in the technical aspects of radioanalytical chemistry and radiopharmaceutical process development and expertise in GMP documentation requirements with a working understanding of 21CFR 212 regulatory guidelines. Previous experience working with radiopharmaceuticals and CMOs strongly preferred.

Other Requirements: Exceptional knowledge of scientific field of specialization. Familiar with Code of Federal Regulations parts 210 and 211 and supporting regulatory inspections. Demonstrated skills in leading projects on an assigned team. Able to properly handle and minimize exposure to potentially hazardous chemical, or radiological materials. Required to follow all safety procedures, and use personal and protective equipment provided. Demonstrated competence in the design and documentation of complex experiments focused on a specific topic. Expanded scope to include multiple related questions for a given program. Routine and or frequent lifting, with reasonable accommodations. Demonstrated ability to effectively communicate ideas and information, both in oral and written form. Travel (including international) is highly anticipated.