PPD Hiring for Sr Group Leader Job at Athlone , Ireland Full Time

Senior Group Leader (Pharma) – 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 clinical research services — 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.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

One of the largest Labs of its kind in Europe, 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 Pharma and Biopharma laboratory groups.

We are currently looking for a Senior Group Leader to join our Pharma Team!!

The role of Senior Group Leader is to provide oversight and supervision of staff and resources performing pharmaceutical development studies such as method development and validation, stability, QC, etc. Manages the work activities of group and Associate group leaders, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff and troubleshooting method and product-related issues. Senior Group Leaders also ensure the compliance of work performed within the laboratory as well as working with manager to meet the financial goals of the organization.

Key responsibilities

• Reviews and approves study protocols, project status reports, final study reports and other project related technical documents. Designs experimental studies and participates in technical troubleshooting.
• Allocates, schedules and manages laboratory resources for group’s project activities and updates project status and revenue projections. Reviews timesheet reports for billing accuracy.
• Reviews data for technical quality and compliance to protocols, methods and SOPs. Approves laboratory investigations, deviations, QA facility and data audits. Leads client and FDA audits.
• Responds to clients questions and needs; leads client technical meetings. Provides recommendations to clients on analytical and compliance issues.
• Prepares and approves proposals, project definition and pricing. Participates in project definition and negotiations with client on timelines and budget.
• Identifies business opportunities at conferences, workshops, within the community, through client interaction, etc. Participates in technical sales and marketing; prepares technical marketing materials. Works with business development as technical representative for client visits/discussions.
• Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.
• Accountable for group’s knowledge and application of good practices pertaining to GMP/GLP and / or other laboratory / client requirements.
• Participates in bi-annual SOP review& change. Ownership of changes needed to comply with SOPs.
• Regularly communicates to staff quality related issues and items for staff development and implements quality improvements.

Experience and Qualifications:

• Educated to a Bachelor’s Degree level in a relevant area, ie chemistry, biochemistry.
• 8+ years’ experience in the Pharmaceutical or Analytical Contract Laboratory industries within Stability, QC or analytical development departments.
• 2+ years’ experience managing teams of technical staff, including Lab supervisors, team Leaders / Lab leaders, with proven leadership record and evidence of team development.
• Ability to cultivate a collaborative work environment within a team and across business areas
• Ability to independently develop project proposals/plans
• Project and time management skills
• Proven ability to identify and implement common efficiencies across multiple programs/projects
• Full understanding of cGMP requirements, client SOPs, ICH guidelines, EP and USP requirements and EMA and FDA guidance’s.
• Strong ability to perform root cause analysis and implement effective CAPA.
• Knowledge and experience of a wide range of techniques, HPLC, UPLC. KF, GC, FT-IR, etc

At PPD Clinical research services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

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

Does this sound like you???

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

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