Principal Scientist/Associate Director, Bioanalytical Group Leader
- Cambridge, MA
- Region: US
· Leading a group of scientists and associates in developing LC/MS methods and analyzing nonclinical and clinical samples of various modalities including small molecule compounds and oligonucleotides
· Analyzing nonclinical and clinical samples and solving analytical technical problems in the labs
· Managing CROs to enable nonclinical and clinical sample analysis
· Writing bioanalytical reports that are suitable for inclusion in registration dossiers (IND/IMPD, IB, NDA/BLA)
· Guiding career development for the reports
· Developing and implementation of new bioanalytical technologies
· Publishing scientific papers and present results at external scientific meetings
· Representing DMPK in project teams to support drug discovery and development projects
· Extensive experience in small molecule nonclinical and clinical bioanalysis and in managing CRO.
· Capable of performing bioanalysis and solving bioanalytical technical problems
· Familiar with regulatory guidance and expectations for GLP study bioanalysis
· Strong records of scientific publications and bioanalytical reports for regulatory submission
· Excellent communication and people skills
· Success in monitoring scientists
· Experience in representing DMPK in project teams desired but not required
The successful candidate will have a degree in Analytical Chemistry or a related field, including a BS or MS degree with at least 15+ years of industry experience, or a PhD degree with at least 10+ years of industry experience.
Biogen’s DMPK group is seeking an enthusiastic leader with strong expertise in bioanalysis to lead our small molecule bioanalytical group to support drug discovery and development of innovative therapies. The candidate is an expert in small molecule bioanalysis in supporting GLP and non-GLP studies, possesses excellent communication and people skills, and demonstrates success in mentoring scientists. The candidate can effectively engage with CROs, manage budget, and solve bioanalytical problems.