CEL - Stability Specialist
Job Number: 21-05317
Job Number: 21-05317
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Stability Specialist for our client in Phoenix, AZ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The Specialist Stability is responsible for handling the stability program for all commercial products internally and externally.
- Performing tracking and trending stability data results.
- Key Subject Matter
- Expert in commercial drug product and drug substances stability.
- Advanced understanding of pharmaceutical regulatory requirements and their impact to commercial laboratory operations
- Advanced knowledge in stability protocol definition
- Advanced knowledge in tracking and trending stability data using statistical software programs
- Advanced understanding of global and regulatory requirements associated with stability programs
- Advanced skills to drive development of technical or scientific initiatives
- Advance experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles.
- Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas within laboratory operations
- Advanced Ability to oversee external service providers involved in stability studies
- Advanced written and verbal communication skills
- Advanced ability to work independently, and/or lead and participate in team projects
- Advanced knowledge of Microsoft Word, Outlook, and Excel
- Advanced presentation and delivery skills
- Advanced knowledge in English and French (Swiss only)
- Commercial Stability program:
- Responsible for the handling of commercial stability program for Client products: scheduling, batch selection, setup, sampling, coordination, etc.
- Responsible for the creation of stability protocol as well as Master Data management and the creation of stability study (e.g.LIMS system)
- Track and trend stability data for commercial products internally and externally
- Participate in external and internal audits
- Responsible for the global stability SOP / WP
- Prerequisites Minimum 5 years’ experience in Quality Control/Analytical Research
- Development in small molecule/biologics; BSc Chemistry, Biology,
- Microbiology or relevant discipline
- May be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment.
- May be fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, etc.
- Will have to perform work in a controlled environment with strict glove and gown requirements.
- Will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product.
- Must have the ability to pass an initial full physical exam, potentially including a respiratory certification with annual monitoring.
- May be working in a laboratory setting up to 6 hours per day.
- Will be required to sit at a desk and type/view a monitor for extended periods of time.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Paul Quibuyen | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.