Research Scientist: Biopharm HPLC and GMP

Job Description

Job Ttitle: Research Scientist: Biopharm HPLC and GMP

Company: Thermo Fisher Scientific


Description: Work ScheduleFirst Shift (Days)
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards
Job DescriptionAt 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.Thermo Fisher’s clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.Summarized PurposeWe are looking for a highly motivated person to support analytical development and routine testing of new biological entities (NBEs) in cGMP environment. In this position as a Research Scientist, you should possess a thorough understanding of laboratory procedures and can reliably conduct complex analysis independently. You should be proficient with method development / optimization and validation processes and be able to design and execute the experiments with no supervision. You should possess great verbal and written communication skills and be able to collaborate with cross-functional scientific teams. Instrumentation is mainly large molecule HPLC (such as SEC, IEX or RP) and/or icIEF and CE-SDS. Independently follow validated or experimental analytical procedures. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Perform troubleshooting on multiple analytical instrumentation, calculate, interpret, record, and verify data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client. Routinely act as technical leader and mentor and interact with client projects leads to provide updates. Write and review analytical protocols and reports and other project related technical documents.Key responsibilities:

• Independently performs analytical testing, method optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and executes experiments independently.
• Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
• Routinely demonstrate scientific initiative and creativity in research activities.
• Works with multiple functional groups to meet business needs.
• Sets up and maintains laboratory equipment, optimizes laboratory operations for efficient use of time and resources.
• Leads troubleshooting of equipment and experimental problems.
• Ensures QA findings are addressed appropriately.
• Provides technical guidance and training to staff.
• Communicates project status, data and technical issues to project lead and responds to leaders’ needs and questions.
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP).
• Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
• Understands and adheres to corporate standards regarding code of conduct, safety, and cGMP compliance.
• Responsible for compliance with all applicable client policies and procedures.
• Demonstrates high proficiency across a wide range of relevant technologies and maintains a high level of productivity in the lab and/or pilot plant.

Education and Experience:

• 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).

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:

• Demonstrated knowledge of multiple applicable techniques such as: Compendial analysis, Coulometric Karl Fisher, UV-VIS, HPLC, icIEF and CE-SDS and other biopharmaceutical testing.
• At least one year of cGMP experience in a regulated lab is required.
• Proficient in Microsoft Excel and Word.
• Proficient in Empower.
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance.
• Proven ability to interpret data by performing trend analysis.
• Understanding and knowledge of general chemistry and separation science.
• Proven ability in technical writing skills.
• Proven ability to independently optimize analytical methods.
• 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 independently perform root cause analysis for method investigations.
• Statistical knowledge and experience are preferred.
• Ability to work in a collaborative work environment with a team.
• Ability to be flexible and be able to re-prioritize in a short notice to meet business needs.
• Ability to train and mentor junior staff.

Working Environment:Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects up to 25 poundsAble to work in non-traditional work environments.Able to use and learn standard office equipment and technology withproficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Compensation and BenefitsThe salary range estimated for this position based in Illinois is $72,000.00-$120,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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

For more information on our benefits, please visit:

Salary: $72000 – 120000 per year

Location: North Chicago, IL

Date: Fri, 24 Jan 2025 06:55:28 GMT


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