The successful candidate will have a PhD with at least 10-15 years of industry experience, and will currently be in a BA/DMPK leadership position. Expert knowledge of BA and drug metabolism principles and regulatory guidances is required. The candidate must be a seasoned and experienced BA and DMPK scientific leader, be highly motivated, and have excellent interpersonal, written and oral communication skills. Prior experience with INDs, BLAs and/or NDAs is required. He/she will have demonstrated success in various aspects of DMPK sciences, and have practical experience in assay method development and troubleshooting. A strong knowledge in GxP regulations that pertain to Bioanalytical Development is required, as is experience in writing documents to be included in regulatory submissions for NDA/BLA. The position will work closely with the Research QA group to ensure that the BA activity follows stated procedures and processes and is always ready for compliance inspections by regulatory agencies.
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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.