Job Description
Job Description
Position : Senior Analytical Project Manager
Salary : $100,000 to $140,000 per year
Location : Germantown, MD (ON-SITE)
Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 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, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers . To learn more, visit www.pharmaron.com.
Job Overview :
The senior analytical project manager will project manage metabolism studies (inclusive of quantitative profiling and metabolite identification) for full dose and Accelerator Mass Spectrometry (AMS)-enabled study designs.
Responsibilities : Study Management
- Act as Analytical Project Manager on clinical metabolite profiling and identification studies.
- Review and finalize sample analysis plans and amendments, study reports.
- 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.
- 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 hit in the month, flagging up any issues early. Ensure resource allocated to their studies is effectively utilized.
- Review data obtained and prepare study updates and study data for discussion internally and for communication to the client / inclusion into reports.
- Address findings arising from QA audits and process inspections.
Project Management
Support BD and operations at the proposal stage for inquiries that will require project management support.Liaise with BD to raise supplementary proposals for scope changes / additional studies.Work with BD and the client to ensure all necessary pre-study information is obtained from the client and distributedWork closely with operations for the scheduling of projects and making sure they stay on track.Prepare and update Smartsheet to keep timelines and revenue up-to-date.Monitor and manage individual project timelines, liaising with Clients and with Operations / QA, as required.Communicate regularly with clients to ensure their expectations are understood, managed and met as appropriate.Chair and circulate action points from regular telephone conferences with clients and relevant parties as required.Ensure sponsors are kept informed of study progress and there is good communication between different areas supporting integrated study operations.Actively participate in and where necessary lead client facility.As a recognized expert in a Metabolism; increase the profile of the department externally through playing an active role in expert groups, networking and publications.What We're Looking For :
PhD, MSc or BSc (Hons) in Chemistry, Biochemistry or related subject with many years' experience in metabolite identification in a CRO or Pharmaceutical / Agrochemical company and industry recognised expert in this area.Experience in chromatographic method development in a GLP or GCP facility.Expert in use of High Resolution Mass Spectrometers e.g. Waters Vion, Thermo QExactive.Expert in relevant software e.g. Xcalibur, Waters UNIFY, Compound Discoverer.Knowledge of metabolism / metabolic reactions.LC-MS / MS data interpretation skills.Experience in project management.Why Pharmaron?
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.
Collaborative Culture : You will 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 Centred" 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.
Benefits : As part of our commitment to your well-being, we offer a comprehensive benefits package :
Insurance including Medical, Dental & Vision with significant employer contributionsEmployer-funded Health Reimbursement AccountHealthcare & Dependent Care Flexible Spending Accounts100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance401k plan with generous employer matchAccess to an Employee Assistance ProgramHow 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!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
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