Principal Scientist, Pharmaceutical Analytical Sciences

Responsibilities

• Leading analytical teams driving the development of drugs in the pipeline, with a deep understanding of product development from early stage through commercialization.
• Actively partnering with other functional areas to design scientific studies guiding product and process development.
• Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices (including method development and validation as well as specification setting).
• Authoring IND, IMPD, and NDA/WMA submission documents across the project development lifecycle, as well as responding to agency questions.
• Promoting scientific excellence and regulatory influence through leadership in the scientific community.
• Advancing and expanding analytical capabilities via the adoption and implementation of novel technologies for product and process characterization.
• Mentoring and providing day-to-day oversight of junior analytical scientists.
• Representing the team and/or department via presentations to governance committees and other internal audiences.
• Partnering with director-level management to develop and execute scientific and enterprise strategies.
• Proactively identifying and escalating program risks.
• Fostering strong collaborations with internal stakeholders and external partners.

Qualifications

Applicants must hold one of: PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience; Master's Degree with at least 10 years of pharmaceutical industry experience; or Bachelor's Degree with at least 12 years of pharmaceutical industry experience.

Required Experience and Skills

• Strong team player with excellent written and oral communication skills, leadership and interpersonal skills.
• Deep technical expertise and strategic experience in analytical control strategy development and execution.
• Demonstrated ability to develop talent through good mentoring skills.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays.
• Strong technical problem solving ability.
• A proven record of external scientific engagement demonstrated by scientific publications and presentations.
• Ability to work both independently and cross-functionally for successful transfer methods.
• Plan optimization and documentation to meet program deadlines.
• Authoring and reviewing internal technical reports, sections of regulatory filings and external scientific publications.
• Experience with matrix management and peer to peer coaching.
• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills

• Hands-on chromatography (e.g., LC, GC) method development, analysis and troubleshooting.
• Other advanced analytical techniques such as mass spectrometry or dissolution.
• Experience in development and characterization of small and/or large molecules, mRNA, and/or antibody drug conjugates and their associated drug products.
• Established scientific reputation supported by publications and external presentations.
• Experience in high-throughput experimentation and data-rich experimentation, or data science.