Full-time

Manufacturing and Supply Chain

North Billerica, MA

Position Summary
Supports senior Scientists in developing new and improved statistical processes and controls in the qualification of contract manufacturing sites, including radiopharmaceutical facilities; provides statistical analysis support of internal needs; process development; radiolabeling processes and detection; and/or commercial production performance indicators. 

These efforts support the economical, efficient, and safe manufacture of radiolabeled precursors, bulk drug substances, and/or drug products.  This position supports the preparation of experimental drug materials used in analytical, process design, formulation design and clinical investigations.  Responsibilities also include the review and resolution of issues involving these efforts to ensure acceptability of materials manufactured by or for Lantheus.
 
This is the second level of Scientist position.  At this level the incumbent executes independent technical work against a series of complex strategies requiring the application of highly complex scientific/technical processes; is a proven, technical leader with a track record in multiple technical or research areas; has specialized statistical knowledge and advanced data analysis techniques, with latitude for independent judgment, decisions, and will provide solid engagement in solving specific project/technical problems; may lead technical efforts and provides statistical consultation services across departmental functions or teams.
 
Essential Functions
  • Ability to work on routine and non-routine projects simultaneously with a high commitment to meet the project timelines and objectives, within LMI SOPs and governing regulations.
  • Possesses at least rudimentary knowledge of the allied disciplines in the product development and commercial disciplines (e.g., regulatory, compliance, supply chain, quality control, quality assurance, etc.).
  • Develops procedures, design and implement a range of assignments. Troubleshoot problems with complex software, algorithms, and statistical systems and may guide other team members.  Independently selects methodological approach and specific methods to achieve program objectives.  Consults with supervisor for understanding of experimental designs and interpretation of results.  Applies the ability to distinguish unusual or new results.
  • Familiarized with data mining of extensive or cloud-based database platforms and ability to construct trend analysis.
  • Adept at creating or modifying database mining algorithms
  • Demonstrated track record of building databases (such as  Oracle/SQL/PostgreSQL/MySQL/AWS) from paper concept to full implementation.
  • Ability to build interphases (for uploading/importing data & sensitive documents) across multiple sites into a controlled access platform.
  • Have a track record of interpreting of GMP batch records (or similar complicated process record) and understanding basic chemical terminology. 
  • Uses sound judgment.  Effectively weighs risks, costs and benefits to make rational and appropriate decisions.  Uses drive and dedication to make significant contributions and to ensure that program goals are met in a timely manner.  Effectively balances duties in order to meet short- and long-term objectives.  Works with increasing independence and accountability.  Develops and delivers technical presentations to group(s), independently.
  • Exercises judgment and demonstrates ability to support technical lead on multiple activities for a project.  Executes on innovative approaches to complex problems in statistical aspects of a development or commercial platforms.  Identifies, analyzes, and interprets project results.  Evaluates results and examines implications to program in a collaborative team manner, especially with regards to safety risk factors.
  • Performs routine statistical analyses, following detailed instructions (protocols, statistical analysis plans).  Demonstrates ability to follow SOPs and LMI procedures as written.
  • Communicates statistical ideas and information in an appropriate and timely manner.  Employs active listening skills to maintain clear communication to others.
  • Exhibits an increased understanding of statistics, stays aware of new statistics and regulatory developments and is able to incorporate these into their design and analysis work. Demonstrates the ability to identify and apply relevant science/ technology to improve group productivity.
  • Evaluates results and examines implications to program with minimal direction.  Accurately documents results in established formats.  Prepares written reports on all phases of laboratory and/or field experimental work with limited direction.  Demonstrates experience in writing technical documents using templates.
  • Maintains current training with cGMPs and other training requirements as identified in the LMI ISOTrain system.
  • Advocates for full legal compliance and ethical conduct in all business transactions.   Demonstrates professional leadership both within the company, in the industry, and community.
  • Actively promotes safety rules and awareness.  Demonstrates good safety practices at all times including appropriate use of protective equipment.  Reports and takes initiative to correct safety & environmental hazards.
  • Actively demonstrates the Lantheus values of accountability, quality, efficiency, customer service, collaboration, and safety.
Typical Minimum Skills and Experience and Education
  • Ph.D./M.S./B.S./B.A. in Mathematics, Chemistry, Pharmaceutics, Engineering (or equivalent) with a fundamental understanding of the technical aspects of applied statistics.
  • Training in analytical chemistry and/or pharmaceutical process development is a plus.
  • Requires a minimum of a Ph.D. degree and 0 – 3 years relevant work experience or a M.S. degree and 3+ years relevant work experience or a B.S. degree and 5+ years relevant work experience.
Other Requirements
  • Demonstrated mastery of scientific field of specialization.
  • Demonstrated competence in the design and documentation of complex experiments focused on a specific topic. 
  • Able to learn and apply new experimental/statistical techniques after training.  Able to train others on newly acquired skills.
  • Demonstrates expertise in advanced computer and mathematical skills.
  • Awareness of GxP documentation requirements.  
  • Demonstrated ability to effectively communicate ideas and information, both in oral and written form, and work in a team setting.
  • May serve as a technical subject matter expert.
  • Routine and or frequent lifting, with reasonable accommodations.
  • Travel (including international) may be required