QC Analytical Technology ManagerLocation Cork, Ireland Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Quality Control Analytical Technology Manager is responsible for leading laboratory personnel that perform Method Validations, Transfers & Optimizations..
The position requires knowledge and experience with method transfer, method validation and regulatory requirements of same..
It is expected that the incumbent will lead in a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
The incumbent must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities.
- Lead the laboratory personnel responsible for transferring drug substance and drug product methods.
- Provide technical expertise and leadership to the QC group supporting troubleshooting and optimizations.
- Support and lead business process improvement projects.
- Participate in budget planning. Communicate capital equipment needs, facility needs, staffing needs; and contract service requirements.
- Interface with other BioMarin departments (Quality Control, Regulatory Affairs, Quality Assurance, etc.) and contractors as necessary.
- Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives.
- Identify and conduct personnel training for quality control personnel, prepare performance appraisals and recruit staff.
PhD/M.Sc. with at least 8 years of experience in a relevant functional area, or a B.Sc. with at least 10 years experience in a relevant functional area (at least 2 years in Quality Control).
- 8+ years experience in a cGMP regulated Quality Control environment.
- Demonstrated expertise with analytical methods used to assess biologics. Experience in bioassay and Q-PCR is also desireable.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.
Approx. a team of 10
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.