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Senior Scientist Analytical Development and CMC Small Molecule
2 months ago
Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
The Senior Scientist, Analytical Development and CMC Small Molecule reports to Director of Manufacturing Analytical Development. This is a small molecule focus analytical development role supporting new and improved analytical methods and commercial processes, physicochemical characterizations in support of process development, and/or technology transfer to Contract Manufacturing Organizations (CMO). These efforts support the economical, efficient, and safe manufacture of bulk drug substances, and/or drug products. This position, based in Northern Billerica, is to provide wide-ranging technical support to MAD and QC laboratories with extensive laboratory expertise and experience. The qualified candidate must be self-directed, be a great team player, and have excellent communication skills to be considered for this role. Preference given to those candidates who have experience in life sciences or FDA regulated cGMP industries.
Essential Functions
- Work with minimal supervision to achieve personal objectives, while constantly realigning to meet evolving organizational needs.
- Provide technical and guidance in lab support to manufacturing, multiple QC laboratories and the overall Quality Organization to resolve test issues, conduct OOT/OOS investigations, identify and improve problematic methods, and drive innovation.
- Participate in and contribute to projects of diverse nature across organizational units, such as: R&D and MTD method development, method validations; technology transfer between R&D and QC, or Tech Ops and third-party labs; and post-NDA process changes.
- Maintains laboratory notebook, record keeping, and laboratory safety in accordance with common industry GMPs and LMI procedure.
- Provide Quality and Technical support for post-NDA initiatives and new product launches.
- Support on key Quality Committees, such as Compendial Change Control, Document Change Control, or Stability Review.
- Provide technical input during regulatory and corporate inspections and audits.
- Maintain and grow personal scientific, regulatory and compendial expertise, and work with lab management to develop organizational capabilities.
- Exhibit high personal standards for Safety, Quality, Performance, Personal Development and Core Behaviors.
- Serve as a technical writer to support MTD and QC organization for internal and external communications, including regulatory submissions and responses.
Required Skills, Experience, and Education
- D./M.S./B.S. /B.A. in Chemistry, Pharmaceutics with a fundamental understanding of the technical aspects of analytical chemistry and pharmaceutical process development.
- Requires a minimum of a Ph.D. degree and 0 – 2 years relevant work experience or a M.S. degree and 3+ years relevant work experience or a B.S. degree and 6+ years relevant work experience in the pharmaceutical industry.
- Experience in Analytical Chemistry is highly preferred. Three (3) to five (5) years’ experience in laboratory operations in a pharmaceutical CMC environment, experienced in chromatography data systems.
- Experience in analytical QC or R&D lab using HPLC/GC analysis and empower/LIMS, is strongly preferred.
- Excellent verbal and written communication skills
- Demonstrate working understanding of laboratory operations and practices strong organizational and/or project management skills.
- Strong analytical development and problem-solving skills.
- This position requires flexibility with changing priorities.
Other Requirements
- Possess enhanced technical skills and command of analytical laboratory instrumentation and equipment. Familiarity with HPLC-UV, HPLC-CAD, GC, GC-MS, KF and wet chemistry.
- Travel may be required.
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
