Stability Specialist

Competitive
Contract
Dublin
22 Jan 2020
BBBH751550

A Stability Specialist is required to join a Product Quality team in a global bio-pharma company based in South Dublin.

Description:

A Stability Specialist is required to join a Product Quality team in a global bio-pharma company based in South Dublin.

This role works alongside colleagues in the Dublin site and reports into a global leadership team the states. As such, the successful candidate is expected to work under minimal supervision.

As a Specialist Stability you will provide support to the organisation as a subject matter expert of clinical and commercial product stability studies and GMP data management.

The non-lab based role will oversee the management of Stability studies and testing for a new Synthetic molecule.

In this role, you will directly add to the success of a Product Quality Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance, Quality Engineering, International Quality and Process Development on projects, issue resolution and investigations.

The Specialist Stability builds and monitors stability studies within quality systems (e.g. LIMS), owns and handles product quality and stability data and may serve as a primary author on regulatory filings and directly participate in and support site-based GMP inspections.

Additional responsibilities include business process support, such as SOP authoring and management, or gap assessments to regional regulations. Expertise in project management, time management and successfully navigation skills for matrixed team environments are essential.

Key Responsibilities include

  • Build and maintain technical GMP documents and product stability studies
  • Review, verify, report, and archive GMP data for clinical and commercial products
  • Apply keen attention to detail to conduct data review and reports
  • Execute transactions in relevant GMP computer-based systems (change control, LIMS, etc.)
  • Adeptly manage time-sensitive activities independently

Basic Qualifications

  • Master's degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience, or
  • Bachelor's degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications

  • BSc. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field
  • Experience working in a regulated environment (either direct GMP or technical support)
  • Strong project management skills
  • Understanding synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
  • General knowledge of cGMP and US and international filing regulations pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals
  • Experience working on a cross-functional team in a matrix environment

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Aoife Duggan's picture
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