Associate Principal Scientist, Analytical R&D

Associate Principal Scientist – Pharmaceutical Analytical Sciences

Location:

Rahway, NJ.

• Lead or participate in analytical teams driving drug development in our pipeline from early stage to commercialization.
• Partner with functional areas to design scientific studies guiding product and process development.
• Define and implement end-to-end analytical control strategies for clinical supplies under GMP, including method development, validation and specification setting.
• Author investigational new drug (IND), investigational medicinal product dossier (IMPD), and NDA/WMA submission documents across the project lifecycle, responding to agency questions.
• Promote scientific excellence and regulatory influence through community leadership.
• Advance analytical capabilities by adopting and implementing novel technologies for product and process characterization.
• Design and execute experiments to influence programs with data-driven decisions.
• Mentor and provide oversight of junior analytical scientists.
• Represent team/department via presentations to governance committees and internal audiences.
• Identify and elevate program risks proactively.
• Build strong collaborations with internal stakeholders and external partners.
• Apply product development and commercialization knowledge to analytical development challenges for small molecules, peptides, mRNA, oligonucleotides, and bioconjugates.
• Use conventional and novel technologies through collaboration with cross-functional teams and external vendors.

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with at least 3 years pharma industry experience; or Masters with at least 7 years; or Bachelor’s with at least 10 years.
• Strong team player with excellent written and oral communication skills, leadership and interpersonal skills.

• Technical expertise and strategic experience in analytical control strategy development and execution.
• Mentoring skills for talent development.
• Ability to take initiative, creativity, and innovation in problem solving.
• Design, execute and/or direct development and qualification of release, characterization, and stability assays for clinical trial material and support product and process development.
• Strong technical problem-solving ability.
• External scientific engagement demonstrated by publications and presentations.
• Work independently and cross-functionally to develop analytical methodologies and transfer methods, plan optimization and documentation to meet program deadlines.
• Author internal technical reports, regulatory filings (IND, BLA), and external scientific publications.
• Experience with matrix management and peer-to-peer coaching.
• Deliver complex objectives under aggressive timelines in rapidly changing environments.

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

Salary range: $ – $.

Eligible for annual bonus and long-term incentive, if applicable.

Comprehensive benefits package including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, 401(k), paid holidays, vacation, and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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