Associate Research Scientist - LC-MS
Associate Research Scientist - LC-MS (Boston, MA) - 229301
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.
Responsible for the regulatory and scientific conduct of assay development, validation, and/or other specialty technologies pertaining to biophysical and biochemical characterization. Performs independently troubleshooting on multiple analytical instrumentation (HPLC, UPLC, LC/MS, CE etc.) and laboratory automation platform (Hamilton, Tecan, etc.), calculates and interprets data, and records data in adherence with SOPs and any additional requirements specific to the lab and / or client. Routinely acts as a technical SME for multiple projects and programs, interacts with – stakeholders on a weekly basis (or as needed) to provide updates, reviews and evaluates data, writes reports and protocols.
Essential Functions:
- Develop new testing methods or transfer existing testing methods for biophysical and biochemical characterization of cell and gene therapy biopharmaceuticals (AAVs and gene edited cells)
- Develop and execute test methods in support of cell and gene therapy Process Development activities (e.g., SEC-HPLC, RP-HPLC, CESDS/cIEF, LCMS intact mass/peptide mapping, etc.)
- Automation development of manual assay with lab automation platform, in support of high throughput analysis/screening need.
- Troubleshoot, optimize, and trend assay performance
- Report on project progress, contribute to analytical development protocols and reports, provide technical recommendations to management
- Transfer assays to testing team and provide SME support for assay qualification, author and review transfer/qualification protocols and reports
- Maintain excellent written documentation (e.g., ELN lab notebook)
- Assist with lab organization and compliance with lab safety protocols
At PPD, part of Thermo Fisher Scientific we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.
To learn how PPD, part of Thermo Fisher Scientific can advance your career, apply now!
Education and Experience:
- Bachelor's degree in Biochemistry, Cell & Molecular Biology, Analytical Chemistry or equivalent and relevant formal academic / vocational qualification
- Previous industry experience that provides the knowledge, skills, and abilities to perform the job:
- Associate Research Scientist: With a bachelor’s degree comparable to 6+ years, with a master’s degree comparable to 4+ years, with a PhD comparable to 2+ 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.
Preferred Experience:
- Experience with analytical CMC method development as per ICH guidelines.
- Hands-on experience with the following assays: High Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), Liquid Chromatography coupled with Mass Spectrometry (LC-MS), capillary electrophoresis (CE)
- Preferred but not required experience with laboratory automation platform
- Experience working with AAVs strongly preferred.
- Experience with Hamilton, Tecan, etc.
Knowledge, Skills, and Abilities:
- Ability to understand and independently apply GMPs and /or GLPs to everyday work about documentation and instrument use
- Ability to independently optimize analytical methods
- Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team
- Time management and project management skills
- Problem solving and troubleshooting abilities
- Experience with sample management and ELN/LIMS systems strongly preferred
- Ability to work in a fast-paced environment
Working Environment:
PPD, part of Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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.
- As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!