Job Introduction
Position: Study Manager- Accelerator Mass Spectrometry
Location: Hoddesdon
Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.
We’re proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules to biologics and gene therapies, and we work with more than 3,000 global customers. To learn more, visit www.pharmaron.com.
About the Role
Pharmaron is currently looking to recruit a Study Manager to join the - Accelerator Mass Spectrometry (AMS) team at our Hoddesdon site. In this role, you will be responsible for managing clinical AMS enabled studies, including mass balance, metabolite profiling and identification and IVPK (absolute bioavailability).
Key Responsibilities
- To act as analytical project manager on mass balance, metabolite profiling and identification and IVPK (absolute bioavailability) studies
- Prepare analytical work plans and study reports and SOPs as required
- To understand (through hand-on laboratory training), the analytical techniques and procedures involved in AMS-enabled clinical studies
- Take full responsibility for the conduct of experimental work required to successfully fulfil all the requirements of a study to the timelines stated in the Study Plan.
- To review study data and prepare summaries and study updates for internal and external reporting
- Contribute to the review and QC checking of all relevant study data packages and reports prior to submission to Quality Assurance as required.
- To collaborate with other AMS teams and Pharmaron stakeholders
- Work closely with clinical site and client to ensure requirements in terms of timelines are understood and can be met.
- Plan work to ensure revenue recognition milestones on assigned studies are met and flagging up any issues early.
- Actively contribute to client visits and teleconferences as appropriate.
- Address findings arising from QA audits and process inspections.
- To collaborate with global AMS and metabolism team members and contribute towards continuous improvement and efficiency optimization
- Contribute to the building of a high performing, passionate team responsive to client needs through managing group objectives and coaching and mentoring junior team members.
Candidate Profille
- PhD, MSc or BSc (Hons) in Chemistry, Biochemistry, Physics or related subject
- Experience of managing analytical studies within a GxP setting
- Experience of working in drug discovery and/or development projects with appreciation of related disciplines
- Managing external collaborations
- Experience of managing analytical studies / projects in support of Phase I trials (e.g. hADME / SAD / MAD) is desirable
- Experience of coordinating / prioritizing multiple projects to meet internal and external
- Effective written and verbal communication skills, including the ability to effectively present
- Effective problem solving and analysis skills
- Flexible mindset with the ability to take the initiative.
Why Pharmaron?
Collaborative Culture: Thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.
How to Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.