Work ScheduleStandard (Mon-Fri)
Environmental ConditionsLaboratory Setting
Job DescriptionThis is a fully onsite role based at our bioanalytical laboratory at 8700 Quioccasin Road in Richmond, VA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Discover Impactful Work:Independently performs and oversees a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications. Coordinates and supervises laboratory activities of other team members in conjunction with the lab supervisor. Leads study design and protocol authoring. Leads data evaluation and study close-out. Provides advanced technical guidance and mentorship to junior and senior scientists. Develops and optimizes new analytical methods and procedures. Manages multiple projects simultaneously, ensuring timely completion and adherence to quality standards. Acts as a primary point of contact for client interactions and project updates.
A Day in the Life:- Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
- Independently performs and gives guidance on a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
- Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
- Leads advanced troubleshooting for various equipment & instruments.
- Reviews and compiles results from assignments and makes determination on acceptability per SOP acceptance criteria. Reviews overall study results.
- Navigates the OOS/OOT/Atypical investigation process. Leads more complex investigations and Root Cause Analysis and leads CAPAs.
- Independently manages QC responsibilities. Communicates project status to project leader and helps to address gaps and solutions to overcoming roadblocks in project team workflow. May act as project leader.
- Coordinates and supervises laboratory activities of other team members in conjunction with lab management.
- Performs study design & protocol authoring. Leads data evaluation and study close-out. Independently completes QA facing tasks. Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross departmental input and/or collation of data etc.).
- Mentors other staff members in applicable areas.
Keys to Success:BS and eight years of experience OR
MS and six years of experience OR
PhD and four years of experience
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities: - Intermediate knowledge of relevant scientific principles applicable to role
- Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and regulatory guidance
- Full knowledge of technical operating systems
- Ability to independently optimize analytical methods
- Ability to independently perform root cause analysis for quality records
- Proven technical writing skills
- Proven problem solving and troubleshooting abilities
- Effective written and oral communication skills as well as presentation skills
- Time management and project management skills
- Ability to mentor others on technical operating systems
- Ability to independently review and understand project proposals/plans
- Ability to work in a collaborative work environment with a team
Working Conditions and Environment: Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
- Occasional drives to site locations, occasional domestic travel
- Exposure to biological fluids with potential exposure to infectious organisms
- Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste
- Personal protective equipment required such as protective eyewear, garments and gloves
- Exposure to fluctuating and/or extreme temperatures on rare occasions
