Sr. Scientist CMC Process Development

^{Position Summary}

Operates with a high degree of independence and is adept at conceptually outlining studies to design and execute focused projects or a series of complex procedures. Drives development 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. Completes work in a resourceful, self-sufficient manner and is able to develop creative solutions to achieve business goals. 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 SOPs and governing regulations. Independently selects methodological approach and specific methods to achieve program objectives. In collaboration with other investigators and scientists, writes original proposals for research projects.
• Deliver innovative solutions and work in a fast-paced, deadline-driven environment while being able to adapt to changing priorities
• Participate in technical troubleshooting sessions for processes and products manufactured in-house and at CMOs as needed and in investigating atypical/OOS results.
• Exercises judgment and initiative in making project decisions and demonstrates ability to handle multiple activities for a project. Devises innovative approaches to complex problems in a specific aspect of a development or commercial programs or platforms. Works on complex problems of diverse scope. Identifies, analyzes, and interprets project results. Evaluates results and examines implications to program.
• Performs routine laboratory work, following detailed instructions. 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 procedure.
• Exhibits an increased understanding of radiochemistry, stays aware of new scientific developments and is able to incorporate these into their development work.
• 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.
• Keeps abreast of science, literature developments within field, program direction and current business issues.
• 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.
• Applies knowledge of site wide policy and implications for Development. Writes SOP's and implements policies with directions. Independently writes reports and procedural documents in accordance with established protocols.
• May be responsible for planning, assigning, directing, and evaluating the work of Scientists. Implements coaching, counseling and performance management programs to improve capabilities and performance as well as maintain accountability for performance and behavior.
• 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 accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

^{Typical Minimum Skills and Experience and Education}

• Degree in Chemistry or related discipline or equivalent relevant industry experience
• Requires a minimum of a Ph.D. degree and 4+ years relevant industry work experience or a M.S. degree and 6+ 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 analytical chemistry and radiopharmaceutical process development and expertise in GMP documentation requirements.
• Extensive experience in developing and qualifying analytical methods using HPLC/UPLC/LCMS/GC-based methods, and a thorough understanding of regulatory guidelines.

^{Other Requirements}

• Mastery of regulatory requirements for job and extended group functions, expertise with regulatory requirements for pharmaceutical development.
• Exceptional knowledge of scientific field of specialization.
• Demonstrated skills in leading projects with an assigned team.
• Able to properly handle and minimize exposure to potentially hazardous chemical, radiological and or biological 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