Associate Research Scientist - Vaccines

Thermo Fisher Scientific • Richmond, VA

2d • Onsite

About The Position

This is a fully onsite role based at our 2244 Dabney Road location 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.

Requirements

• 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.
• PhD and two years of experience
• Knowledge of relevant scientific principles applicable to role
• Ability to independently perform root cause analysis for quality records
• Proficiency on technical operating systems
• Proven problem solving and troubleshooting abilities
• Proven ability in technical writing skills
• Time management and project management skills
• Good written and oral communication skills
• Ability to work in a collaborative work environment with a team
• Ability to train junior staff
• Ability to mentor others on technical operating systems
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and regulatory guidance

Nice To Haves

• 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

Responsibilities

• Independently performs 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.
• Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications.
• Coordinates laboratory activities of other team members in conjunction with the lab management.
• Performs study design and protocol authoring.
• Leads data evaluation and study close-out.
• Provides technical guidance and mentorship to junior scientists.
• 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 troubleshooting for various equipment & instruments
• Reviews and compiles results from assignments and makes initial 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.
• 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 as needed.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree