Analytical Sciences Director
$178,500–$257,833 year
On-siteCambridge, Massachusetts, United States
Job Summary
Lead all analytical sciences activities for synthetic and small molecule drug development at the Cambridge Crossing site, covering drug substance, oral drug product, and clinical manufacturing support from IND to NDA approval. Develop advanced analytical strategies and technologies to drive First-in-Class programs while advancing the laboratory's digitalization and automation roadmap. Manage a dynamic team of high-level scientists, oversee outsourced activities, and ensure resources align with strategic project priorities. Drive process chemistry support, control strategy development, and stability studies across all development stages. Represent the company in internal and external forums to promote a collaborative, one-team culture and facilitate rapid decision-making for global regulatory filings.
Required Qualifications
- BS in Analytical Chemistry or related field with at least 14 years of relevant experience within the pharmaceutical industry
- MS Analytical Chemistry or related field with at least 12 years of relevant experience within the pharmaceutical industry
- PhD in Analytical Chemistry or related field with at least 10 years of relevant experience within the pharmaceutical industry
- At least 3+ years demonstrated people management and leadership experience
- Strong knowledge of pharmaceutical regulatory requirements (ICH guidelines, EMA/FDA regulations, and international standards)
- Proven experience in clinical trial documentation and regulatory dossier submission
- Strong scientific track record in analytical sciences in R&D
- Advanced scientific network within academia and industry
- Experience in managing teams of high-level scientists
- Strong knowledge in GMP, ICH requirements, pharmacopoeia
- Demonstrated experience in clinical dossier and CTD submissions
- Solid understanding of CMC aspects of drug development and related functions, including chemistry, physical quality and formulations
- Demonstrated technical, and organizational skills; ability to work in a matrix organization
- Show initiative and creativity in proposing, developing and executing ideas
- Encourage experimentation, educated risk taking and learning from failure
- English
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