Analytical Group Supervisor, Athlone, Ireland
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health . You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Our GMP laboratory based in Athlone, Ireland offers fully integrated solutions for product development and analytical development, including analytical testing services in method development, method validation, method transfer, release and stability studies. Our highly qualified GMP lab staff work across our 3 laboratory groups: Biopharm, Small Molecule, and Inhalation.
The role of Associate Group Leader is to provide support to our BioPharm department by providing management and direction to a group of laboratory staff and resources for project activities and needs, overseeing daily operations to monitor quality and project timeliness, and assist in preparation and implementation of company policies, quality systems and training programs. Key responsibilities:
Qualifications: Education & experience:
- Management of a team of analysts
- Allocation, scheduling and managing laboratory resources for group's project activities and updates LIMS for project status. Reviews timesheet reports for billing accuracy.
- Preparation, review and approval of study protocols, project status reports, final study reports and other project-related technical documents.
- Designing experimental study and participates in technical troubleshooting.
- Reviewing data for technical quality and compliance to protocols, methods and SOPs. Review and approve laboratory investigations, deviations, QA facility and data audits. Assists in client and regulatory authority audits.
- Responding to client questions and needs; leads client technical meetings.
- Assisting in preparation of proposals, project definition and pricing.
- Coordinating and prioritizing project activities with internal functional groups (physical testing, analytical development, etc.) and support functions (QA, sample management, etc.)
- Assisting senior group leaders and/or managers in their responsibilities.
- Preparation and implementing SOPs and company operational policies. Ensuring adherence and making recommendations to quality system improvements.
- Educated to a Bachelor's Degree level in a relevant area, ie chemistry, biochemistry
- Management experience in the pharmaceutical, biotech or analytical contract laboratory industries
- Stability/QC/analytical R&D/project and program management.
- Direct supervision of technical staff.
- Full understanding of GMP requirements, client SOPs, ICH guidelines, EP and USP requirements and EMEA and FDA guidance's.
- Knowledge and experience of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry .
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD -
- Joining Bonus
- Pension scheme
- Annual Leave 25 days
- Medical Health care cover
- Life Insurance
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. 1
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.