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Stryker

Associate Quality Manager, Stability

Cary, IL · On-site

$112K - $188K/yr

Lead and continuously advance a bestinclass Stability program, ensuring compliance with global regulatory requirements (ICH, FDA, ISO) and inspection readiness at all times * Provide strategic and ...

Novartis

Senior Expert Stability

East Hanover, NJ

$118K/yr

Knowledge of ICH, specifically stability guidelines. * Excellent oral and written communication skills with technical writing experience, with expertise in use of MS suite of programs (outlook, excel ...

Moderna, Inc.

Sr. Manager, CMC Stability

Norwood, MA · On-site

Familiarity with ICH stability guidance and global regulatory expectations related to expiry dating, storage conditions, and post-approval commitments. * Experience supporting stability-related ...

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How much do stability ich jobs pay per hour?

As of Jun 29, 2026, the average hourly pay for stability ich in the United States is $27.88, according to ZipRecruiter salary data. Most workers in this role earn between $21.15 and $32.45 per hour, depending on experience, location, and employer.

What are Stability Ich jobs?

Stability Ich jobs are roles focused on ensuring that pharmaceutical products remain stable, safe, and effective over their intended shelf life, in compliance with International Council for Harmonisation (ICH) guidelines. Professionals in these roles design, conduct, and manage stability studies, often analyzing how drugs respond to various environmental factors like temperature, humidity, and light. They also generate and interpret data to support regulatory submissions and maintain product quality. These jobs are critical in the pharmaceutical and biotechnology industries to meet global regulatory standards.

What are the key skills and qualifications needed to thrive as a Stability ICH Specialist, and why are they important?

To thrive as a Stability ICH Specialist, you need a solid background in pharmaceutical sciences, analytical chemistry, and regulatory guidelines, often supported by a relevant science degree. Familiarity with ICH stability protocols, laboratory information management systems (LIMS), and data analysis software is crucial. Attention to detail, organizational skills, and effective communication are essential soft skills for accurate documentation and cross-departmental collaboration. These competencies ensure regulatory compliance, reliable product quality, and successful coordination of stability studies within the pharmaceutical industry.

What are the typical challenges faced by professionals working in Stability ICH roles within the pharmaceutical industry?

Professionals in Stability ICH roles often encounter challenges such as managing multiple stability studies simultaneously and ensuring strict adherence to ICH guidelines and regulatory requirements. The role demands keen attention to detail when documenting and interpreting data, as well as effective coordination with cross-functional teams like Quality Assurance, Regulatory Affairs, and Manufacturing. Timely reporting and troubleshooting unexpected results are also common, requiring strong problem-solving skills and adaptability to shifting project priorities.
Associate Director, Stability Management

Associate Director, Stability Management

Exelixis

Alameda, CA • On-site

$172K - $244K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 13 days ago

Key responsibilities

  • Establish and manage stability policies, procedures, and performance metrics for drug substance, drug product, and reference standards.

  • Oversee and manage stability studies, including writing and reviewing protocols, monitoring testing, reviewing and trending data, investigating out of trend results, and authoring reports.

  • Supervise and direct staff within the stability group, including hiring, scheduling, performance review, and work assignment.

Job description

SUMMARY/JOB PURPOSE:
The Associate Director, Stability Management is responsible for the establishment and management of the stability group withing Exelixis CMC department. This role oversees the overall strategy and oversight of Exelixis' stability and reference standard programs for drug substance, drug product and reference standard for both the commercial and clinical programs. Additional responsibilities include, establishing Exelixis stability policies, procedures, and performance metrics internally and externally with CMOs. Will provide oversight over the CMOs' execution of the stability studies, authoring of the stability protocols, interim stability reports, and final stability reports. This role requires strong personnel resource management, communications, technical writing, and statistical analysis skills.
Essential Duties And Responsibilities:
  • Establish Exelixis stability policies and procedures
  • Establish and manage performance metrics
  • Oversee direct reports from the stability group

Manage activities related to drug substance and drug product stability testing, both commercial and clinical:
  • Write and review stability protocols according to International Conference on Harmonization (ICH) guidelines.
  • Manage and monitor contract laboratory stability testing to ensure adherence to the stability scheduled outlined in the stability protocols.
  • Review stability data (including raw test data).
  • Trend and track stability data and to determine drug product shelf life/retest date according to ICH guidelines.
  • Investigate out of trend or out of specification results according to industry best practices.
  • Manage, chair and present in regularly scheduled stability committee meetings.
  • Write final stability reports for completed stability studies.
  • Review and assess temperature excursions during storage and/or during transportation.
  • Generate certificate of analysis and retest memos, setting and justifying specifications for both release and stability testing, and regulatory document controls.

Supervisory Responsibilities:
  • Supervise staff, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions, or terminations.
  • Provide direction to other individuals.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
  • BS/BA degree in related discipline and a minimum of eleven years of related experience; or,
  • MS/MA degree in related discipline and a minimum of nine years of related experience; or,
  • PhD degree in related discipline and a minimum of five years of related experience; or,
  • Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:
  • GMP experience preferred
  • Technical laboratory experience in small molecules and solid oral dosage preferred.
  • Experience in Pharmaceutical industry preferred.

Knowledge/Skills:
  • Has extensive experience in relevant industry/profession and area of specialization.
  • Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
  • Identifies and implements methods and procedures to achieve results.
  • Performs a variety of complicated tasks with a wide degree of creativity and latitude.
  • Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
  • Has good general knowledge of other related disciplines.
  • Applies strong analytical and business communication skills.

JOB COMPLEXITY:
Working Conditions:
Environment: primarily working indoors in an office environment
Travel required - 10% of travel required
#LI-MB1
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $172,000 - $244,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: recruiting@exelixis.com
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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