Principal Scientist
3 weeks ago
Job Description
Position Summary:
The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and grows as a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. They will work within the Analytical Development team to characterize drug substance, drug product, impurities, degradants, and metabolites from pre-clinical research through drug development and commercialization. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.
Responsibilities
- Provide subject matter expertise in analytical development methodologies at Alkermes requiring internal laboratory execution and technical oversight/supervision
- Guide and drive analytical method development, method implementation, product characterization and analytical control strategy development for pre-clinical and clinical stage development programs
- Design, execute, and analyze analytical method validation and transfer activities suitable for progressive stages of small molecule pharmaceutical development that are in compliance with ICH and FDA guidance
- Work closely with colleagues across Pharmaceutical Development and Research organizations to best leverage internal and/or external capabilities, equipment and instrumentation to identify and document critical factors to impact method performance
- Provide timely technical support and management oversight of analytical activities at external partners, which may include product characterization, GMP in process, release and stability testing, laboratory investigations, and method performance issues
- Develop, review, and approve analytical source documents, and author and review drug product and drug substance analytical sections for regulatory submissions
- Present technical data to cross functional teams and senior management as an analytical expert, and effectively communicate critical analytical issues and solutions
- Identify and advocate new and emerging technology opportunities for analytical and physical characterization
- Train and mentor more junior Analytical Development staff, as needed
- Perform other duties as assigned
Qualifications
- PhD (>8 years) or MS (>15 years) with related experience in analytical chemistry, organic chemistry, or biochemistry
- Expertise and demonstrated experience in small molecule analytical method development, validation and transfer
- Experience managing external testing laboratories throughout drug development
- Technical problem-solving ability utilizing current research and technologies
- Broad understanding of the drug development process and more precisely the role and impact of analytical development within this process
- Demonstrated collaborative leadership, strong interpersonal skills, and excellent verbal and written communication skills
- Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
- Subject matter proficiency across a range of spectroscopic, titration, dissolution and separation-based analytical methodologies and laboratory software systems
- Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities
- Previous experience with applying DoE in method development is preferred
#LI-MB1
About Us
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
-
Principal Scientist, Protein Analytics
1 week ago
Waltham, Massachusetts, United States Dragonfly Therapeutics Full timePrincipal Scientist, Protein AnalyticsDragonfly Therapeutics is seeking a Principal scientist who brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel immunotherapy programs forward. The candidate must be independent, goal-oriented, flexible, and able to work efficiently across multiple projects. We are searching for...
-
Principal Scientist
1 week ago
Waltham, United States Alkermes, Inc. Full timePosition Summary:The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and grows as a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. They will work within the Analytical Development team to...
-
Principal Scientist
5 days ago
Waltham, United States Alkermes, Inc. Full timePosition Summary: The Principal Scientist position within Analytical Development provides technical leadership for small molecule analytical methodologies and grows as a subject matter expert both within and outside the department as part of a growing, dynamic Pharmaceutical Development organization. They will work within the Analytical Development team to...
-
Sr. Scientist/Associate Principal Scientist
2 weeks ago
Waltham, United States Alkermes Full timePosition Summary The Senior Scientist/Associate Principal Scientist position within Analytical Development leads small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. They will collaborate with cross-functional teams on analytical method development, molecule characterization, testing and analysis throughout...
-
Sr. Scientist/Associate Principal Scientist
1 week ago
Waltham, United States Alkermes, Inc. Full timePosition SummaryThe Senior Scientist/Associate Principal Scientist position within Analytical Development leads small molecule analytical activities within a growing, dynamic Pharmaceutical Development organization. They will collaborate with cross-functional teams on analytical method development, molecule characterization, testing and analysis throughout...
-
Research Scientist, Lurie Institute
2 weeks ago
Waltham, United States Brandeis University Full timeForms project teams and may serve as principal investigator or co-principal investigator in addition to project manager on independent research studies. Devises optimal approaches to meet scope of work and ensure timely high-quality submissions and d Research Scientist, Research, Scientist, Diversity, Technology, Education
-
Principal, Metallurgical Engineer
3 weeks ago
Waltham, United States Simpson Gumpertz and Heger Inc Full timeCOMPANY OVERVIEW Simpson Gumpertz & Heger (SGH) is a national engineering firm committed to delivering holistic advice for our clients' most complex challenges. We leverage our collective and diverse experience, technical expertise, and industry knowledge of structures and building enclosures, advanced analysis, code consulting, materials science, and...
-
Waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Principal Investigator, Translational Science
3 weeks ago
Waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Principal Investigator, Translational Science
4 weeks ago
Waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Clinical Research Manager I
2 weeks ago
Waltham, United States Boston Childrens Hospital Full timeJob Posting DescriptionThe department of Orthopedics and Sports Medicine is host to the Clinical Effectiveness Research Center, a collaborative initiative that supports the research efforts of principle investigators, fellows, residents, medical students, and scientists. CERC is comprised of research staff from diverse educational and social backgrounds that...
-
Senior Medical Director
3 weeks ago
Waltham, United States Clinical Dynamix Full timeResponsibilities:Provides clinical leadership and strategic medical input for all clinical deliverables in critical projects.Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff, and others as necessary to develop and execute clinical trials from beginning to end.Drives clinical strategy and leads...
-
Senior Medical Director
2 weeks ago
Waltham, United States Clinical Dynamix, Inc. Full timeResponsibilities:Provides clinical leadership and strategic medical input for all clinical deliverables in critical projects.Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff, and others as necessary to develop and execute clinical trials from beginning to end.Drives clinical strategy and leads...