Stability Scientist Job

STABILITY SCIENTIST needed for a CONTRACT opportunity with Yoh's client located in PARSIPPANY, NJ.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- ICH stability requirements
- International medicinal GMPs

WHAT YOU'LL BE DOING:

- Represent Stability on multiple new product development project teams and provide guidance regarding stability regulations/requirements
- Ensure that stability aspects of new products are assessed, reviewed and maintained throughout all development phases
- Ensure all work is conducted in accordance with written procedures
- Maintain awareness of global regulations impacting stability
- Review, assess, challenge and implement (where appropriate) new/draft regulations
- Provide input to, review and approve stability protocols
- Use the LIMS to create and initiate stability testing protocols
- Coordinate the outsourcing of stability samples for testing
- Monitors daily schedule for sample testing and communicates within GSK and contract sites
- Review of stability data to establish expiry terms, to include trend and statistical analysis
- Prepare data summaries and assessments for regulatory submissions
- Apply scientific principles and techniques to assigned projects
- Evaluate and provide scientific justification for risk taking
- Ensure stability chambers are maintained in a validated status
- Ensure stability chambers maintain required environmental conditions
- Review and approval of departmental documentation (including SOPS, WI, validation protocols, reports, expiry memos etc.)
- Provide site wide SOP or functional training
- Evaluation, recommendation, approval and subsequent implementation of new technology/policy
- Assist and/or drive for continuous improvement eg develop and implement metrics/improved way of working
- Act as GSK representative at meetings/symposia held by regulatory/academic/professional bodies
- Retain and develop technical skills through publishing and presenting work in peer reviewed technical journals and at internationally recognized scientific meetings

WHAT YOU NEED TO BRING TO THE TABLE:

- BS/MS/Ph.D in a science-related discipline or equivalent experience required
- Expert knowledge of ICH stability requirements
- Knowledge of international medicinal GMPs
- Computer literate and experience of using laboratory information management systems (LIMS)
- Clear communicator in both oral and written forms
- Ability to multi task and set priorities
- Proficient team working and customer-interface skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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