Associate Research Specialist, Forced Degradation
About this role
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
This is a fully onsite role based at our customer’s site in Upper Providence, PA. 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.
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.
Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.
Role Summary:
Performs laboratory analysis of pharmaceutical drug substances and drug products in an R&D setting. Works within a team to characterize small molecules/biologics in clinical development using HPLC and stress testing/forced degradation techniques.
Key responsibilities:
• Design and execute forced degradation (stress testing) experiments to elucidate degradation mechanisms and facilitate structural characterization of degradation products in a variety of formulations and/or delivery systems
• Collaborate with team to analyze and interpret complex analytical data and communicate results to influence project team decisions related to degradation risks and potential mitigation strategies
• Independently perform assigned analytical testing and document findings with precision
• Understand and conform to methods, protocols, SOPs, etc. applicable to assigned tasks
• Adhere to good laboratory practices and documentation standards to ensure data integrity
• Laboratory-based role with routine handling of chemicals and reagents; adherence to safety protocols and PPE required
• Learn new analytical techniques to flexibly meet the analytical needs of the department including but not limited to spectroscopic, biophysical, liquid chromatographic techniques
Education and Experience:
• PhD within Chemistry ( Organic/ Synthetic Chemistry) and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’)
• OR BS degree and Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+years’)
• Strong analytical skills ( HPLC/ Mass Spec)
• Fundamental understanding of organic reaction mechanisms
• Forced degradation
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:
• Expertise in organic chemistry, including structural characterization, knowledge of reaction mechanisms, chemical kinetics, and experience in mechanism elucidation.
• Experienced in chromatography and separations techniques (e.g., (U)HPLC, GC, etc.) including method development and troubleshooting
• Experience with chromatography software (e.g., Empower, OpenLab CDS, etc.)
• Ability to use Microsoft Excel, Word, PowerPoint, and other applications to perform tasks
• Familiarity with stress testing and forced degradation studies
• Hands-on experience preparing samples for qualitative and quantitative analytical testing
• Proficiency in operating, maintaining, and troubleshooting analytical instrumentation
• Familiarity with compendial testing and regulatory guidelines (e.g., ICH, USP, EP)
• Familiarity with GxP and ALCOA++
• Experience in spectroscopic techniques (e.g., MS, NMR, IR, etc.)
• Excellent problem-solving skills, detail-oriented, methodical; able to produce reproducible, high-quality data
• Strong interpersonal and communication skills; able to work effectively in cross-functional teams
• Strong verbal and written communication skills
• Prioritize tasks, manage multiple projects, and meet deadlines
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 pounds
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with
• proficiency.
• 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.
Benefits
We 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!