Senior Bioanalytical Scientist

Position
:
Senior Bioanalytical Scientist, LC-MS Large Molecule Method Development

Salary
: $100,000 to $130,000 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

• The senior scientist will lead the execution of LC-MS/MS assay development, validation, and sample analysis activities.
• Contributes to the training, monitoring, and mentoring of staff as necessary
• Prepares data tables and reports within Laboratory Information Management Systems (Watson™)
• Participates in data transfers, pre‑clinical and clinical data management tasks
• Prepares or reviews standard operating procedures for use by the Company, as required
• Always complies with company Standard Operating Procedures unless specifically defined and approved in the study‑specific assay validation or sample analysis plan
• Assists in training personnel in the operation, maintenance, and troubleshooting of laboratory equipment
• May perform Principle Investigator (PI) activities such as:
  • Serves as main point of contact with sponsors for all assigned study related deliverables
  • Hosts regularly scheduled client teleconferences throughout the course of the study
  • Assists in reviewing the laboratory manual, clinical protocol, data transfer agreement and other miscellaneous documents prepared by sponsor and/or clinic
  • Oversees the project by designing the experimental approach, overseeing the experimental execution, collating, and interpreting scientific data and generating study reports, working in close co‑operation with study sponsors at all stages
  • Carries out laboratory tasks, working with other laboratory staff to progress study‑specific experimental work and, as necessary, to support non‑study‑specific laboratory duties
  • Works closely with the sample management team in sample login as well as transfer, storage, and disposal of the study samples
  • If required, draft bioanalytical report for method validation and study sample analysis.
  • Works closely with Quality Assurance team in scheduling study data and report audit, critical phase inspection and collaborating with team members in addressing each of the study findings
  • Assists in archiving study related documentation, including email correspondence and electronic raw data files
  • May train and assist other lead scientist in study related investigation
• Provides scientific and technical support to colleagues in the Business Development group, as required. This may involve participation in client visits, both inbound and outbound as well as attending and presenting at scientific conferences.

• PhD;
  Master of Science OR Bachelor of Science in relevant field.
• A minimum of 5 years experience in LC‑MS large molecule bioanalysis method development.
• Experience working in a CRO environment.
• Knowledge of Good Laboratory Practice (GLP) regulations (21 CFR part 11 and 58) and Good Clinical Practice (GCP) regulations.

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…