Process and Analytical Development Technical Specialist

Location
Cork
Salary
Negotiable
Posted
12 Jul 2017
Closes
09 Aug 2017
Ref
JP25
Contact
Justin Pankinas
Sector
Manufacturing
Job Type
Contract
Hours
Full-time
Process and Analytical Development Technical Specialist
Our client is a global health care leader with a diversified portfolio. Their ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, they strive to create an environment of mutual respect, encouragement and teamwork. As part of their global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Process and Analytical Development (P&AD) group require a Technical Specialist with strong analytical experience to provide multidisciplinary expertise and technical support to the P&AD team.

Job Description:
The successful candidate will be responsible for assisting in the effective and efficient running of analytical projects and will be active members within the wider Technology team to provide Technical support, guidance and expertise to ensure the success of the team.
A high level of innovation, enthusiasm and drive will be required to deliver technical excellence for a number of analytical transfers, method development, method qualifications, and small scale process optimisation studies.
The Scientific Technical Specialist provides in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan. This role is responsible for all aspects of method and equipment validation, assisting in the effective and efficient running of the method, equipment validation and small scale optimisation operations programs. In addition, providing on-going technical support to the site in the area of contamination control. Works with moderate work direction and is skilled and knowledgeable to the position.

Responsibilities:
*Good knowledge of protein chemistry and analytical techniques such as HPLC, SDS-PAGE, IEF, CE, ELISA and general compendial methods.
*Perform laboratory experiments required to deliver on project timelines
*Participate in continuous improvement initiatives, including method optimisation and troubleshooting
*Support small scale process optimisation activities
*Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
*Lead and Participate in cross-functional problem solving teams for troubleshooting, and investigations within API, Sterile and Quality functions
*Qualification of laboratory equipment and small scale process equipment
*Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
*Adhere to highest standards
*The Process and Analytical Development (P&AD) group require a Technical Specialist with strong analytical experience to provide multidisciplinary expertise and technical support to the P&AD team.

Qualifications, Skills & Experience Required
*MSc/BSc. qualification (Science)
*At least 3 years' experience in an analytical/ small scale process development role in QC or an analytical/process development group.
*High level written and verbal communications with advanced PC skills.
*Self-motivated and ability to work as part of a team with good project management skills.
*Demonstrated ability to fully realize improvement initiatives.
*Demonstrated successes in a team environment, such as project teams, problem solving teams etc.
*Stakeholder management of multiple decision makers, corporate colleagues, cross functional teams.
*Desired Qualifications/Experience:
*Project management qualification such as, Project Management Professional (PMP) Evidence of Continuous Professional Development.

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