Associate Principal Scientist Process Analytical Technologies (PAT) | Meath
Initial focus of this role will be on supporting the start-up activities by leading the and transfer of the PAT Technologies.
Overview of Main Responsibilities (full job description available on request):
- Technical lead for Process Analytical Technologies (PAT) and site Subject Matter Expert (SME). Identify, develop and maintain professional and credible relationships with the healthcare community.
- Close partnership with the analytical, manufacturing and automation teams on site and with the counterparts from R&D and early clinical manufacturing.
- Procurement and equipment qualification, including authoring of GMP documents like User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), or work instructions.
- Support interactions with Health Authorities and filings in regard to “Integrated and Advanced Analytics”.
- Coach, mentor and technical leadership for scientific staff executing the PAT’s.
- Connect at the interface between Manufacturing and Analytics.
What the ideal candidate looks like:
- Ph.D. in analytical chemistry, biochemistry, biology or related field with a minimum of 3 years of experience or M.S. with a minimum of 7 years of experience or Bachelor’s with a minimum of 10 years of experience in the Pharmaceutical Industry.
- Hands-on experience with advanced PAT tools (e.g. Raman, Capacitance, Online LC)
- Detailed knowledge of relevant IT systems (e.g. SIPAT, DeltaV, SBOL, Empower)
- Detailed understanding of GMP requirements for Hard and Software Qualification according to current health authority and data integrity standards.
- Broad analytical and process understanding, with a preference for understanding of continuous bioprocessing and knowledge of chemometrics/multivariate data analysis.
What you will get in return:
- Competitive salary.
- Bonus.
- Pension.
- Healthcare.
For a confidential discussion and more information on the role, please contact Aisling Lane.
aisling.lane@collinsmcnicholas.ie
(021) 4320675