Manufacturing Stability Scientist

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Stability Administrator to join our team. In this role, you will be responsible for coordinating and maintaining stability programs supporting sterile injectable products. This role ensures that all stability studies are executed in compliance with ICH guidelines, FDA regulations, and cGMP requirements, supporting Hikma’s commitment to delivering high-quality, affordable medicines globally.

The position plays a key role in sample lifecycle management, data integrity, and inspection readiness, particularly within regulated, FDA-inspected manufacturing environments.

• Manage stability programs in accordance with ICH Q1A(R2) and Hikma procedures.
• Maintain stability schedules for commercial products, validation batches, and stability commitments.
• Coordinate sample pulls and testing timelines (e.g., 0, 3, 6, 12, 24, 36 months).
• Ensure alignment with regulatory commitments (ANDA/NDA submissions).

• Oversee receiving, labeling, storage, and tracking of stability samples.
• Manage stability chambers under controlled conditions:
• Long‑term, intermediate, and accelerated conditions
• Monitor chamber performance (temperature/humidity) and escalation of excursions.
• Maintain inventory and traceability of samples in compliance with data integrity standards
  .

• Maintain stability protocols, reports, and logs in compliance with:
• cGMP (21 CFR Part 210/211)
• ICH guidelines
• Ensure adherence to ALCOA+ principles for all stability data.
• Enter and verify data in electronic systems (e.g.,
  LIMS, Track Wise, Veeva
  ).
• Support preparation of stability reports for regulatory submissions and annual product reviews (APR/PQR).

• Ensure audit readiness for FDA and international inspections.
• Support internal/external audits by providing accurate and complete documentation.
• Ensure stability program compliance with global regulatory bodies (FDA, EMA, MHRA).

• Document and track stability‑related deviations (e.g., missed pulls, chamber excursions).
• Assist with investigations and root cause analysis.
• Support implementation and closure of CAPA actions in collaboration with QA.

• Partner with:
• QC Laboratories (testing coordination)
• QA (compliance oversight)
• Regulatory Affairs (submission support)
• Manufacturing (batch tracking)
• Support new product launches, technology transfers, and lifecycle management
  .

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline

• 2–5+ years of experience in stability, QC, or GMP documentation in the pharmaceutical industry
• Experience in FDA‑regulated environments required
• Experience with injectable or sterile products preferred

• Strong understanding of:
• ICH stability requirements (Q1A, Q1B)
• cGMP documentation practices
• Experience with:
• Stability tracking systems, LIMS
• Temperature/humidity monitoring systems
• Knowledge of data integrity and audit readiness principles

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma‑sponsored 401(k) program at a pre‑tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that…