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Associate Director Translational Bioanalytical Sciences - Bridgewater, NJ, United States - Insmed
Description
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves.
Named Science's Top Employer in 2021, 2022, and 2023Insmed is dedicated to creating a collaborative environment where our team can thrive.
Every day, our employees turn their passion for science and research into innovative solutions for patients.1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row.
Within the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large molecule quantitative assay development of biological samples.
The successful candidate is expected to establish, monitor validated bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical, nonclinical and biomarkers studies.
This translational role resides within the Clinical Development organization, works closely with colleagues in other functions, including strategic interactions with multiple Research groups.
The role will provide scientific and strategic guidance to global project teams and will oversee the internal and CRO resources as they relate to TBS.
Lead projects, provide oversight of outsourced GxP bioanalytical validations and sample analysis from early to late development for pharmacokinetic and biomarkers studies.
Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety, contract research organizations etc.) Participate in clinical study design and documentation (lab manual, protocol, report, SAP)Participate in preclinical study design and documentation as needed.
Contribute to regulatory document writing (e.g.Engage in scientific advice meetings with regulatory authorities (FDA, EMA, PMDA)Manage customized bioanalytical assays via network of external service providers in advance of and during clinical development.
Identify, evaluate, and manage bioanalytical vendors, partnering with the Procurement function.Qualifications:
PhD or MS in Analytical Chemistry, Chemistry, Biochemistry, or another relevant field.
Minimum of 8+ years' post-doctoral experience or equivalent in the pharmaceutical, CRO or related industry within bioanalytical area across various modalities.
Demonstrated method development and validation experience with various platforms with deep expertise in LC-MS/MS regulated quantification.Advanced knowledge of various mass spectrometry platforms, ionization methods, quantitative analysis techniques for small molecules, hybrid or biological molecules (eg. Familiarity and experience in establishing clinical biomarker analyses for clinical trials.
Travel Requirements
Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.
Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).S.
BENEFITS:
Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Applications are accepted until the position is filled. #
