Sentry BioPharma Services is a leading provider of pharmaceutical product management for temperature-sensitive medications, supporting a global network across fifty countries. Our commitment to quality, innovation, and customer service drives us to develop and deliver reliable solutions for the storage, labeling, packaging, and distribution of vital pharmaceutical products. As part of our ongoing growth, we are seeking a dedicated Analytical Development Scientist to join our team and contribute to advancing our laboratory capabilities and product quality. The ideal candidate will be comfortable working in an evolving startup environment, have excellent problem-solving ability, communication skills, be a strong multitasker with the ability to meet deadlines and have proven leadership experience.

Key Responsibilities:

• Lead the hands-on development, optimization, and validation of analytical methods for small molecules and biologics in compliance with ICH and regulatory guidelines.
• Design and execute analytical studies utilizing techniques such as HPLC/UPLC, GC, LC-MS/MS, dissolution testing, spectroscopy, and other modern analytical tools.
• Collaborate with cross-functional teams to ensure analytical methods meet project requirements and regulatory standards.
• Maintain accurate documentation of method development, validation processes, and study results.
• Support stability testing programs, aliquoting procedures, and analytical testing for new and existing products.
• Maintain laboratory equipment and ensure calibration, qualification, and preventive maintenance activities are completed as required.
• Stay current with industry trends, regulatory updates, and technological advancements in analytical chemistry.
• Drives audit readiness on the team with advanced regulatory knowledge. Conduct Pre-Audit walks through the laboratory space. Available to confidently and competently speak to auditors as QC SME.

Skills and Qualifications:

• Proven experience in analytical method development and validation for small molecules and biologics.
• Proficiency with HPLC/UPLC, GC, LC-MS/MS, and dissolution testing techniques.
• Strong understanding of ICH guidelines, regulatory requirements, and quality assurance processes.
• Excellent problem-solving skills, attention to detail, and ability to work independently and collaboratively.
• Effective communication skills for documenting and presenting technical data.
• Familiarity with ICH guidelines (Q2, Q3, Q6, etc.) and regulatory expectations.
• Experience with biologics, peptides, or advanced modalities.
• Knowledge of statistical tools and software (e.g. Chromeleon, LIMS or other similar tools).
• Experience working in regulated GMP environments.

At Sentry BioPharma Services, we foster a collaborative and innovative environment that values continuous learning and professional growth. Join us to be part of a team dedicated to improving patient outcomes through reliable pharmaceutical solutions and cutting-edge laboratory practices. We offer competitive benefits and opportunities for career advancement in a dynamic industry.

Education and Experience

Ph.D. in Chemistry, Biochemistry, or related field with 5+ years of relevant experience OR M.S. with 10+ years, or B.S. with 15 plus years of relevant experience.