Title: Project Leader - Biologics Division
Location: Co. Mayo, Ireland.
Seeking an experienced Project Leader for the Biologics Division located in Co. Mayo, Ireland.
- Supervise, lead, and manage the transfer and establishment of various methods from client to test lab across multiple disciplines.
- Certify all new methods are validated in accordance with ICH guidelines.
- Formulate study plans and perform studies in strict accordance with SOP's and study plan in accordance with regulatory compliance.
- Link with the Quality Department for the generation of audit responses, deviation reports and the collection of study reports.
- Conduct leading laboratory investigations when necessary.
- Accountable for reporting project progress to Management.
- Issue technical training to scientific team.
- Liaise daily with clients regarding ongoing and upcoming projects.
- Participation with regulatory and client audits.
- Confirm all new equipment is qualified and validated in accordance with GMP and relevant corporate validation requirement standards and guidelines.
- Produce new and update current SOP's.
- Create risk assessments for drug products, substances, and processes.
Minimum requirements for Project Leader - Biologics Division Co. Mayo:
- PhD in a relevant science discipline (e.g., Chemistry, Biotechnology or Biochemistry).
- Minimum of 3 years relevant experience in Testing/Scientific Research, ideally within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
- Exposure to Project Management involving study design, assay development, optimization, ICH analytical validation.
- Experience in analytical and molecular biology techniques (e.g., PCR and Q-PCR or Cell Culture Techniques and virology are desirable).
- Capability to project manage numerous studies.
- Ability for problem solving and to work on own initiative.
- Knowledge and experience with statistical software.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.