Associate Group Leader– Cell and Molecular Biology Lab - 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 Cell and Molecular Biology Lab 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. You will have ownership to ensure responsiveness to the client and overall client
satisfaction. This position has direct supervisory responsibilities of a small group of
- 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.
- Ph.D. in microbiology, immunology or cell biology and experience in developing cellular and immunologically based assays; or equivalent cumulative experience with a lesser degree.
- 5 years’ experience in molecular and cell biology
- Min. 1 year leadership responsibility/direct supervision of technical staff
- Program management.
- Full understanding of GMP requirements, client SOPs, ICH guidelines, EP and USP requirements and EMEA and FDA guidance's.
- Extensive mammalian cell culture experience with adherent and suspension cell lines
- Direct hands-on experience in quantitative and qualitative analysis using immunochemistry or cell based assay techniques is required (for example reporter gene assays, anti-proliferation and cell cytotoxicity assays)
- Strong foundation of knowledge in biological sciences and good aseptic technique is essential
- Ability to develop analytical methods to meet international system suitability expectations is desired
- Experience training junior scientists is essential
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.
- Pension scheme
- Annual Leave 25 days
- Medical Health care cover
- Life Insurance
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 -
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