Durée indéterminée

On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a

Specialist Stability, GQ AS&T

Vos tâches

Purpose and Scope of Position

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.

 

Duties and Responsibilities

Commercial Stability program:
• Responsible for the handling of commercial stability program for Celgene 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
The Official Copy is the electronic file. Verify
document is the Approved version before proceeding. Confidential Printed On: 15 Nov 2021
Status: Approved Version: 3.0
Number: JD-011055 Approved Date: 08 Sep 2021 Title: Specialist Stability, GQ AS&T
Page: 1 of 4
Status: Approved Legacy ID:N/A
Reporting:
• Responsible for the annual stability report
• Manages the master data for stability samples
• Support the management of global reference standards and control products
Support Commercial drug substances and drug product:
• Collaborates with QA on deviations
• Leads work activities involving Change Controls and CAPA’s
• Represents department in cross functional projects
Education and Experience
• B.S. Chemistry, Biology, Microbiology or relevant discipline
• 5 years of relevant work experience required, preferable in a Pharmaceutical environment
• An equivalent combination of education and experience may substitute
• Working Conditions (US only)
• The incumbent may be required to wear uniform/ PPE to work in a manufacturing, warehouse, or
laboratory environment.
• The incumbent may be fully gowned for extended periods of time within a restrictive movement
environment. This may include standing, bending, reaching, kneeling, etc.
• The incumbent will have to perform work in a controlled environment with strict glove and gown
requirements.
• The incumbent will be required to maintain a safety alertness due to work around hazardous
equipment and cytotoxic product.
• The incumbent must have the ability to pass an initial full physical exam, potentially including a
respiratory certification with annual monitoring.
• The incumbent may be working in a laboratory setting up to 6 hours per day.
• The incumbent will be required to sit at a desk and type/view a monitor for extended periods of
time.
• The incumbent must be able to lift/carry NMT 25 lbs.

Votre profil

Education and Experience

• B.S. Chemistry, Biology, Microbiology or relevant discipline
• 5 years of relevant work experience required, preferable in a Pharmaceutical environment
• An equivalent combination of education and experience may substitute
• Working Conditions (US only)
• The incumbent may be required to wear uniform/ PPE to work in a manufacturing, warehouse, or
laboratory environment.
• The incumbent may be fully gowned for extended periods of time within a restrictive movement
environment. This may include standing, bending, reaching, kneeling, etc.
• The incumbent will have to perform work in a controlled environment with strict glove and gown
requirements.
• The incumbent will be required to maintain a safety alertness due to work around hazardous
equipment and cytotoxic product.
• The incumbent must have the ability to pass an initial full physical exam, potentially including a
respiratory certification with annual monitoring.
• The incumbent may be working in a laboratory setting up to 6 hours per day.
• The incumbent will be required to sit at a desk and type/view a monitor for extended periods of
time.
• The incumbent must be able to lift/carry NMT 25 lbs.

Langues

Advanced knowledge in English and French (Swiss only)

Date d'entrée

À convenir


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