SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as the Scientist/Sr. Scientist, Bioanalytical. The scientist will oversee regulated bioanalysis to support non-clinical and clinical studies, will possess deep scientific and technical knowledge, and experience in developing, transferring, optimizing and validating assays of small molecule programs.
The successful candidate should be able to design and oversee the execution of bioanalytical method development and validation studies using LC-MS/MS with minimal guidance and supervision. The qualified candidate will be knowledgeable of current FDA and EMA GLP compliance as it relates to bioanalytical methods. The candidate is expected to be able to manage bioanalytical projects, communicate with Nonclinical and Clinical departments as well as CROs to ensure high quality Bioanalytical data/reports are delivered in accordance with project timelines. This position will report to the Principal Scientist, Bioanalytical of the DMPK Department and interact regularly with multiple levels of the organization, including, Non-clinical Development, Technical Operations, Clinical Operations, and Quality Assurance.
Preferred Qualifications and Experience:
- Knowledge of chromatographic separation, gas phase ionization, and mass spectrometry.
- Hands-on experience of biomatrix sample clean-up and LC-MS/MS for bioanalysis.
- Able to develop and validate bioanalytical methods.
- Able to design and execute stability studies in a variety of biomatrices.
- Experience in identifying and selecting high quality CROs for the conduct of nonclinical and clinical bioanalytical work.
- Able to conduct site inspection/audit and supervising outsourced studies.
- Review and interpret bioanalytical data/reports from nonclinical studies and clinical trials.
- Effectively communicate with multiple departments within the organization as well as CROs.
- Provide project summaries/reports for larger project team meetings.
- Experience in preparation of summary sections for regulatory (IND/NDA/MAA) filings is a plus.
- The successful candidate will have a MS or Ph.D. degree, and have 5+ years of industrial experience in LC-MS/MS bioanalysis, preferably in a GLP environment. Experience in HPLC-UV formulation analysis is a plus. Travel will be required of this position and is anticipated at a maximum of 15%.
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
- Excellent communication and organizational skills and the ability to interact with people from diverse backgrounds.
- Must be authorized to work in the United States for any employer without the need for sponsorship.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.