Description:

The successful candidate would apply sound chemistry and stability planning knowledge to identify and evaluate stability indicating characteristics as part of product changes and new product development. The effective integration of chemistry and stability enables establishment of shelf life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global scale. The Stability Subject Matter Expert designs strategies and makes recommendations that may be non-routine to address technical, regulatory, and business requirements.

•\tSupport development and implementation of stability strategies for new product development and sustaining project activities.

•\tSupport development of GMP stability studies used to establish expiration dating and support labeling for product development.

•\tContribute to the development of technical justifications for expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners.

•\tProvide valuable input to stability assessments and requirements for new products and/or current product changes.

•\tEnsure the right methods and specifications are available for stability, compatibility, and release testing. Ensure that the methods are appropriate for the product design over shelf life.

•\tDemonstrate the ability to identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale.

•\tInteract with manufacturing facilities to acquire information related to test methods and specifications.

•\tAuthor, review and verify technical data, protocols, and reports through use of Quality Documentation System.

•\tAct as study director for stability projects under guidance of senior Stability team members.

•\tPerform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry.

•\tSupport development of new and/or optimization of existing processes and procedures to enhance stability related practices.

•\tParticipate in investigations that correspond to atypical, out-of-specification, or out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data under guidance of senior Stability team members.

•\tLeverage critical thinking to drive the investigation to conclusions based on sound scientific principles.

•\tContribute to stability sections intended for submission to regulatory authorities under guidance of senior Stability team members. Use computerized systems to retrieve, evaluate, and summarize data for reporting.

Additional Skills & Qualifications:

•\tUnder guidance of senior Stability team member, able to organize complex information and demonstrate attention to detail.

•\tLogical and methodical when solving problems, developing solutions, and making sound recommendations with limited input from senior team members.

•\tExperience working with sophisticated databases.

•\tPossess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools.

•\tGood technical writing skills.

•\tProficient in analytical chemistry including theoretical knowledge and practical experience.

•\tWillingness to contribute efforts beyond own scope of responsibilities to ensure project milestones are met.

•\tBasic functional understanding of FDA, ISO, and Quality systems.

•\tWorks well in a team environment across multiple time zones and demonstrates an inclusive attitude.

Bachelor’s Degree with 5-10 years or Master’s degree in a relevant scientific subject area.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.