Associate Research Scientist / Research Scientist
In labs and health care facilities worldwide - HERE WE ARE
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.
Conducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and other 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, LC/MS, etc.) and multiple detection techniques (UV, FL, CAD, ELSD, RI, etc.), methods and procedures. Routinely acts as the technical project leader for multiple projects, provide updates, reviews and evaluates data, writes reports and protocols.
Essential Functions:
- Independently performs analytical method development/optimization/qualification in chromatography, mass spectrometry or other related areas for analysis of proteins, nucleic acids, and AAVs
- Develop and execute LC and MS based approaches and methods for separation, structural elucidation, residual impurity analysis to support AAV process development and product characterization.
- Support investigations with appropriate methodology to solve complex issues regarding assay performance, product quality attributes, and drug substance/drug product manufacturing
- Author and review study protocols, project status reports, final study reports and other project-related technical documents.
- Transfer assays to testing team and provide SME support for assay qualification, author and review method SOPs, method development/transfer/qualification protocols and reports
- Maintain excellent written documentation (e.g. lab notebook and test forms)
- 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!
***This position requires long term eligibility to work in the US without sponsorship. Please note F-1 OPT Visas are not considered long term eligibility for this role.
Job Qualification
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 with a Bachelor's degree OR 6+ years with a Master’s degree OR 4+ years with a PhD degree).
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:
- Hands-on experience with LC, LC/MS, or other biophysical techniques for separation and structural analysis of proteins
- Knowledge of separation and MS technologies (RPLC, SEC, IEX, CE-SDS, MS/MS) is expected
- Proficient in LC/MS data analysis software, such as Empower, BiopharmFinder, and MassLynx/UNIFI
- Excellent written and communication skills, effective time management, and the ability to work independently and collaboratively in a fast-paced environment are required
Knowledge, Skills and Abilities:
- Intermediate knowledge of general chemistry and separation science
- Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
- Full knowledge of technical operating systems
- Ability to independently optimize analytical methods
- Ability to independently perform root cause analysis for method investigations
- 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
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!
Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
COVID-19 Vaccination Update for U.S. Colleagues
• All U.S. colleagues are required to report vaccination status. New hires will be asked to report vaccination status within the first two weeks of employment.
• All U.S. new hires who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), remote site monitors-local (RSM-L) all CRA and RSM-L line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. New hires will be asked to disclose vaccination status upon first day of employment and are required to report vaccination status within first two weeks of employment.