Principal Scientist, Research & Development

We are seeking a highly experienced and innovative Principal Scientist, R&D to serve as a technical subject matter expert in analytical and bioanalytical chemistry, supporting early-phase pharmaceutical development. Reporting to the Senior Director of Regulatory Affairs, this role will independently lead the development, optimization, validation, and transfer of analytical methods for small to medium molecule drug products. The ideal candidate brings deep expertise in GMP/GLP environments, a strong understanding of regulatory expectations, and a passion for driving scientific excellence, operational efficiency, and high-quality data to support regulatory submissions and successful program advancement.

• Graduate degree in Biology, Chemistry or related field, Ph.D. preferred.
• Minimum of 10 years of experience in a similar role.
• Critical thinking, troubleshooting and time management skills aligned with needs of operational areas
• Recognition of method and/or data issues and communicate them to management to minimize study impact independently
• Deep understanding of analytical sciences, drug development process, GMP/GLP requirements, and pharmaceutical industry trends
• Previous experience in pharmaceutical oral solid dosage & parenteral drug product analytical testing
• Experience in developing pharmaceutical small molecules analytical chemistry methods and bioanalytical methods
• Excellent project management skills;
  Ability to communicate complex scientific findings/recommendations and project resource requirements (material, manpower, time, etc.), and elevate relevant issues to project lead and management
• Excellent communication (oral and written), attention to detail, effective problem-solving and decision-making skills
• Ability to work independently and as part of a team with internal clients, self motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Experience in exploration and application of innovative technologies/approaches to analytical development activities
• Experience with transfer of analytical technologies
• Ability to drive performance by tracking and managing key performance indicators using internal and external metrics
• Ability to prioritize complex workloads and manage changing priorities
• Proficiency in IT related skills such as Microsoft excel, word, PowerPoint etc
• Support and build upon the overall technical strength in the bioanalytical group by providing input and guidance on approach, conducting background research, doing feasibility, and drawing on a depth of personal expertise.
• Ensure that final methods discovered from development are fit-for-purpose, and ready for FDA/EMA validation guidelines (where appropriate).

• Perform non-routine analytical activities by independently developing and characterizing stability-indicating methods for early-phase pharmaceutical small to medium molecules with pre-set timelines followed by successful validation and transfer when required.
• Independently develop new and/or refine bioanalytical methods, followed by successful validation and transfer when required.
• Prepare method protocols and technical reports for characterization of analytical methods.
• Participate in technical discussions with project leads to recommend alternatives, research new methods/techniques and discuss potential solutions to problems.
• Plan critical laboratory experiments to investigate aberrant results, determine root cause and recommend action plan
• Prepare data for presentations/technical discussions and transfer methods internally and externally
• Ensure project deliverables are scientifically accurate and meet timeline expectations
• Partner with the Regulatory Affairs team to ensure the method scope and performance meet the requirements.
• Consideration of operational efficiency and cost when developing methods.
• Provide technical and scientific advice to the Regulatory team
• Actively communicate and collaborate across operational areas to adhere to timelines and produce quality data.
• Independently prepare summaries of method development data.
• Write both study and non-study deviations.
• Full understanding of regulatory and GXP requirements, industry standards and company SOPs
• Provide support to staff members as required by operational area as needed.