Associate Principal Scientist, Molecule Analytical Research and Development

Overview

Associate Principal Scientist, Small Molecule Analytical Research & Development (SMAR&D) based in Rahway, NJ. The SMAR&D group focuses on analytical methodologies for medicines based on small molecules, peptides, mRNA, oligonucleotides and bioconjugates. Responsibilities range from early stage to commercialization for drug substances and a broad array of oral, sterile and combination products. You will contribute towards regulatory submissions to enable clinical trials and collaborate with a global team to advance analytical science and predictive tools.

Your main responsibilities will include:

• Leading or participating on analytical teams driving the development of drugs in the Company's 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 investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/worldwide marketing application (WMA) submission documents across the project development lifecycle, as well as responding to agency questions.

Scientific Excellence and Regulatory Influence

• 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.

• Designing and executing experiments needed to influence programs with data-driven decisions.

Leadership

• 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.

• Proactively identifying and escalating program risks.

• Fostering strong collaborations with internal stakeholders and external partners by actively engaging in two-way communication to build trusting relationships.

• Applying an understanding of new product development and commercialization to analytical development challenges for small molecules, peptides, mRNA, oligonucleotides, and bioconjugates, using conventional and novel technologies through collaboration with cross-functional project teams and external vendors.

Education and Experience

Applicants must hold one of the following:

• PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 3 years of pharmaceutical industry experience.

• Master’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience.

• Bachelor’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience.

Required Experience and Skills

A strong team player with excellent written and oral communication skills, as well as leadership and interpersonal skills are necessary to qualify for this role. Additional skills:

• Technical expertise and strategic experience in analytical control strategy development and execution.

• Ability to develop talent through mentoring.

• Demonstrated initiative, creativity, and innovation in problem solving.

• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.

• Strong technical problem-solving ability.

• External scientific engagement demonstrated by publications and presentations.

• Ability to work independently for development of analytical methodologies and cross-functionally for transfer methods; plan optimization and documentation to meet program deadlines.

• Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.

• Experie…