Job Title: Technical Development Senior Scientist / Engineer Commercial
Location: Shanbally, Rinaskiddy, Cork - Hybrid role
This is a senior-level position that requires technical expertise and leadership skills to oversee the development and manufacturing of biologic drug products at external Contract Manufacturing Organizations (CMOs) and internal sites. The successful candidate will be responsible for ensuring that Drug Product manufacturing processes perform as developed and validated, while driving continuous process improvement through the application of scientific and engineering expertise.
Responsibilities:
* Provide technical oversight for product(s) manufacturing/testing executed at external and internal partners
* Act as Technical Development technical representative on process teams
* Act as an SME on biologic Drug Product, including technology transfer, process validation, trouble shooting and investigation on specific product(s)
* Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
* Initiate and lead product improvement projects, involving cross-functional teams
* Establish and maintain internal/external network relationships around control strategy
* Performs statistical data analysis to recognise trends, identify and drive process improvement or minimise product impact
* Assist technical and project management leadership during technology transfers
* Lead risk assessments in support of product(s) technology transfers to external partners
* Identify and lead product and process improvement initiatives to reduce COGM (Cost of Goods Manufactured)
Requirements:
* A minimum of 5 years' relevant experience in the biopharmaceutical industry with a strong MSAT and process development experience in Drug Product biologics
* Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process
* Ability to collaborate in a global team environment at all levels of the organisation
* Ability to start up and lead cross-functional teams in the resolution of short-term issues or sustained performance for long-term goals
* Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of biologics
* Excellent organisational, written and verbal communication and negotiation skills
* Experience with Change Control, Deviation, CAPA, FMEA, RCA tools in a highly regulated manufacturing environment
* Demonstrated strong leadership and coaching qualities
* Minimum B.Sc. (M.Sc. or Ph.D. Preferred) degree in a relevant scientific discipline e.g. biochemistry, microbiology, biological sciences or related biop
Salary: $120,000 - $180,000 per annum