Senior Scientist / Senior Manager - Bioanalysis
Location
Germantown, MD | United States
Job description
Company Overview:
Join our dynamic team at Pharmaron in Germantown (MD), a leading organization dedicated to advancing the understanding of human diseases and enhancing human health through cutting-edge research and development.
Summary:
We are currently seeking a highly skilled and motivated Senior Scientist / Senior Manager specializing in Bioanalytical Method Development to contribute to our mission of improving healthcare outcomes. You will play a pivotal role in advancing our bioanalytical capabilities through the development of robust and reproducible methods for small and large molecule bioanalysis by LC-MS. You will oversee and support method development efforts, collaborate on LC-MS/MS assay development, and contribute to various aspects of pre-clinical and clinical research.
Key Responsibilities:
- Oversee and support the execution of method development efforts for small and large molecule bioanalysis by LC-MS.
- Lead or collaborate on LC-MS/MS assay development, validation, and sample analysis activities.
- Prepare interim or final method development data summaries and analytical methods, providing training to team members.
- Contribute to training, monitoring, and mentoring of staff as necessary.
- Prepare data tables and reports within Laboratory Information Management Systems (LIMS), specifically Watson™.
- Participate in data transfers related to pre-clinical and clinical data management tasks.
- Lead or participate in department-initiated process improvements.
- Provide scientific and technical support to colleagues in the Business Development group.
- Act as a mentor and trainer to team members, identifying areas for development and efficiencies.
- Thorough understanding of FDA bioanalytical method validation guideline.
Additional Responsibilities for Principal Investigator (PI) Activities:
- Serve as the main point of contact with sponsors for all assigned study-related deliverables.
- Host regularly scheduled client teleconferences throughout the course of the study.
- Oversee the project by designing the experimental approach, collating and interpreting scientific data, and generating study reports.
- Carry out laboratory tasks, working closely with other laboratory staff to progress study-specific experimental work.
- Draft bioanalytical reports for method validation and study sample analysis if required.
- Work closely with report writers, Quality Assurance, and other teams throughout the study lifecycle.
Required Education and Experience:
- PhD + at least 5 years of relevant experience; or Master of Science in a relevant field + at least 7 years of relevant experience; or Bachelor of Science in a relevant field + at least 10 years of relevant experience.
- Experience working in a GLP laboratory.
- Familiarity with LIMS (Watson).
- Experience working with mass spectrometers, specifically Sciex platforms coupled with Shimadzu HPLCs.
- Must have experience working for a CRO or CDMO
Benefits:
Pharmaron cares about our work community and offers a variety of benefits, allowing employees to customize a benefits package that meets their personal needs. Company benefits include the following:
- Medical, Dental & Vision Insurance Plan with Employer Contribution
- Health Reimbursement Account Funded by Employer
- Healthcare & Dependent Care Flexible Spending Accounts
- Employee Life and AD&D Insurance 100% Employer Paid
- Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
- Short and Long Term Disability 100% Employer Paid
- 401k with Employer Match
- Employee Assistance Program
About Pharmaron
Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D 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 19,000 employees and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.
Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.
#LI-JB1
Job tags
Salary
