Research Scientist - Bioanalytical R&D - LCMS

Thermo Fisher Scientific•Richmond, VA

3d•Onsite

About The Position

Position: Research Scientist Location: Richmond, VA - 8700 Quioccasin Road Department: Chromatography Science - Research and Development Department This is a fully onsite role based at our BIOA Laboratory 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. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. Discover Impactful Work: The Research Scientist conducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. Designs and executes method development/validation and/or extractable/leachable studies independently and interprets and reviews analytical data for self and others OR designs and executes multiple stability and inhalation procedures as well as assists others in performing routine maintenance and troubleshooting on multiple instruments (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) methods and procedures. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols.

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, and experience. OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ year) OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ year)
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:
LCMS Triple Quad exp is a MUST HAVE
Intermediate knowledge of relevant scientific principles applicable to role, ideally seeking candidates with LCMS and biological matrices experience
Full understanding of GLP, 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

Responsibilities

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.