Principal Scientist (GMP Analytics)

Location: On premise in Groton, Connecticut, United States. Relocation support may be available based on business needs and eligibility.

Annual base salary: $106,000–$176,600, plus a 15% bonus target and eligibility for a share-based long-term incentive program.

Company

hirify.global develops medicines and supports pharmaceutical research, development, manufacturing, and regulatory programs.

What you will do

• Lead phase-appropriate stability strategies for assigned drug substance and drug product programs.
• Design and oversee stability protocols, storage conditions, pull schedules, testing plans, data assessments, and technical reports.
• Evaluate stability results and trends, identify technical and compliance risks, and recommend appropriate actions.
• Author and review stability protocols, investigations, specifications, scientific assessments, and regulatory responses.
• Support CMC submissions and communicate stability data, shelf-life assessments, and commitments with Regulatory Affairs.
• Coordinate stability activities across hirify.global laboratories and external testing partners while supporting GMP investigations, audits, inspections, and continuous improvement.

Requirements

• BA/BS with at least 12 years of relevant experience; MBA/MS with at least 9 years; or PhD with 4–8 years of relevant experience.
• Experience in pharmaceutical analytical development, stability sciences, product quality, or a related discipline in a regulated GMP environment.
• Strong understanding of pharmaceutical stability principles, ICH stability guidance, and quality-system expectations.
• Ability to interpret complex analytical and stability data and communicate clear scientific conclusions.
• Experience working in cross-functional, matrixed environments with strong technical writing and presentation skills.
• Must have permanent authorization to work in the United States; visa sponsorship is not available.

Nice to have

• Experience authoring CMC stability sections, shelf-life or retest-period justifications, stability commitments, and health authority responses.
• Experience designing clinical and registration stability programs, stability trending, comparability assessments, and specification development.
• Experience with internal and external GMP laboratories, contract research organizations, manufacturing partners, audits, inspections, and CAPA activities.
• Familiarity with small molecules, peptides, biomolecules, conjugates, or other advanced pharmaceutical modalities.
• Experience with digital technologies, automation, data visualization, and responsible AI tools such as ChatGPT or Microsoft Copilot.

Culture & Benefits

• Collaborative, multidisciplinary environment with opportunities to lead through scientific influence and mentor colleagues.
• Commitment to quality, compliance, data integrity, inspection readiness, and continuous improvement.
• Comprehensive benefits including 401(k) matching and retirement contributions, paid vacation and holidays, caregiver and medical leave, and medical, prescription, dental, and vision coverage.
• Limited domestic or international travel may be required.