Manager, Bioanalytical Operations, Cambridge, MA
Sarepta Therapeutics is currently seeking an experienced analytical scientist/pharmacokineticist to oversee nonclinical and clinical bioanalytical studies and operations. The ideal candidate will possess a thorough understanding of modern bioanalytical techniques and instrumentation, including experience in regulatory compliance issues supporting GLP and GCP operations. Experience in formulation activities considered a plus.
Excellent understanding of current industry best practices and regulatory guidance.
Primary responsibilities include:
- Support preclinical and clinical departmental bioanalytical needs across multipleproduct development programs
- Manage bioanalytical functions, including oversight of method development, method validation, tech transfer, study reporting and study auditing supporting both internal discovery efforts and external preclinical and clinical contracted studies
- Manage external formulation activities including method development and method validations, review of formulation reports
- Participate in external vendor qualification audits and vendor performance audits
Education and Skills Requirements:
- A minimum of 3 years experience in bioanalytical operations, including previous experience beyond IND for one or more project is highly desirable
- Excellent oral and written communication skills
- Proficiency in bioanalytical problem recognition and solutions through collaborative interactions with colleagues across multiple functions
- In-depth computer proficiency skills in MS Office Suite including developing Gantt charts, Visio drawings, Powerpoint presentations and database management tools; SharePoint and web meeting skills desired
- Minimum of a Bachelors degree in life science (biological, chemical, statistical, pharmaceutical or medical science); advanced degree desirable
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.