5 дней назад
Associate Director, Translational Bioanalytical Sciences
164 000 - 213 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Translational Bioanalytical Sciences (LC-MS/Bioanalysis): Leading regulated bioanalytical method development, validation, and sample analysis for small molecules, oligonucleotides, and biologics with an accent on clinical, nonclinical, and biomarker studies. Focus on overseeing CROs and internal partners, shaping bioanalytical strategies, supporting regulatory submissions, and managing complex mass spectrometry programs across development stages.
Location: Hybrid role based in Bridgewater, New Jersey, United States, with remote work available most of the time and in-person collaboration as needed. Occasional domestic and international travel of approximately 5%–15% is required.
Salary: $164,000–$213,000 annually
Company
is a global biopharmaceutical company developing therapies for patients with serious and rare diseases.
What you will do
- Lead regulated LC-MS/MS bioanalytical activities for small molecules, oligonucleotides, and biologic therapeutics across clinical and nonclinical development.
- Oversee method development, qualification, validation, implementation, and sample analysis for PK, PD, and biomarker endpoints.
- Manage CROs and internal partners, providing scientific guidance, governance, and oversight within a matrixed organization.
- Develop bioanalytical and biomarker strategies with Clinical Development, Research, clinical pharmacology, clinical operations, safety, and external vendors.
- Provide technical expertise in sample preparation, chromatography, mass spectrometry, stability, and quantitative analysis.
- Support clinical and preclinical study documentation, regulatory submissions, regulatory authority meetings, and vendor governance.
Requirements
- PhD or MS in Analytical Chemistry, Chemistry, Biochemistry, or a related field, with at least 10 years of postdoctoral or equivalent pharmaceutical industry experience.
- Extensive experience in bioanalytical sciences focused on small molecules and oligonucleotides.
- Demonstrated expertise in regulated LC/MS method development, validation, and low-molecular-weight analysis through external service providers.
- Knowledge of FDA, EMA, CLSI, M10 Bioanalytical Method Validation, GxP, ICH M10, CAP/CLIA, and ISO standards.
- Advanced knowledge of mass spectrometry platforms, ionization methods, and quantitative analysis for small molecules, proteins, peptides, and oligonucleotides.
- Strong communication, presentation, collaboration, and stakeholder-management skills in a highly matrixed environment.
Nice to have
- Knowledge of ligand binding, flow cytometry, qPCR, cell-based assays, and biological detection or sample preparation techniques.
- Experience with LIMS systems such as Watson or other data systems.
Culture & Benefits
- Medical, dental, vision, and mental health support, along with an annual wellbeing reimbursement and Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP participation, and company-paid life and disability insurance.
- Access to learning programs, leadership development, mentorship, networking, employee resource groups, and service initiatives.
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