Stability Scientist

RXinsider LTD.; Bedford (OH); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with company match

PTO 20 days

Personal days

11 company holidays

Comprehensive health benefits

Employee discount program

Wellbeing rewards program

Tuition reimbursement

Paid maternity/ parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio is seeking a skilled Stability Administrator to coordinate and maintain stability programs for oral and sterile injectable products.

The role ensures studies follow ICH guidelines, FDA regulations, and cGMP requirements, supporting high-quality medicines and regulatory readiness. Responsibilities include overseeing sample lifecycle, data integrity, and documentation, with collaboration across QA, Regulatory Affairs, and Manufacturing to support

Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline.
• 2–5+ years of stability, QC, or GMP documentation experience in pharmaceutical industry.
• Experience in FDA-regulated environments required; injectable/sterile products preferred.
• Strong knowledge of ICH stability requirements (Q1A, Q1B) and cGMP documentation.

Responsibilities

• Coordinate stability programs per ICH Q1A(R2) and company procedures.
• Maintain stability schedules for products and validation batches.
• Manage sample pulls and testing timelines (0, 3, 6, 12, 24, 36 months).
• Ensure alignment with regulatory commitments (ANDA/NDA submissions).
• Support data integrity and audit readiness across systems (LIMS, TrackWise, Veeva).
• Assist with deviation investigations and CAPA actions.

Skills

Stability coordination

Data integrity

Regulatory compliance

Education

Bachelor’s degree in Chemistry/Pharmaceutical Sciences/Life Sciences

Tools

LIMS

Temperature/Humidity monitoring systems

Job description

Job Title: Stability Administrator

Location: Bedford, Ohio

Job Type: Full-Time

About Us:

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.

Description:

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 oral and 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.

Key Responsibilities:

Stability Program Coordination

• 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).

Sample Management & Stability Chambers

• 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 escalate excursions.
• Maintain inventory and traceability of samples in compliance with data integrity standards.

Documentation & Data Integrity

• 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, TrackWise, Veeva).
• Support preparation of stability reports for regulatory submissions and annual product reviews (APR/PQR).

Compliance & Inspection Readiness

• 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).

Deviation, CAPA & Investigations

• 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.

Cross-functional Collaboration

• 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.

Qualifications & Experience

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

Education

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

Experience

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

Technical Skills

• 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

What We Offer*:

• 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 you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.