Scientist II - Extractables and Leachables
Company: Thermo Fisher Scientific
Location: Middleton
Posted on: May 9, 2025
Job Description:
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence
to all Good Manufacturing Practices (GMP) Safety Standards,
Laboratory Setting, Office, Some degree of PPE (Personal Protective
Equipment) required (safety glasses, gowning, gloves, lab coat, ear
plugs etc.)Job Description Job Description 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. Discover Impactful Work: Possesses a
thorough understanding of laboratory procedures and can reliably
conduct complex analysis with increased independence. 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.
Follows validated or experimental analytical procedures with
periodic direct supervision. Responsible for review and compilation
of results and data comparison against SOP acceptance criteria,
methodology, protocol and product specifications. Enters data into
databases and reports. Performs self-review for own data prior to
QC submission. A day in the Life:
- 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 for stability and analytical testing.
- Works with multiple functional groups to meet business
needs.
- Plans and organizes work with periodic supervision.
- Sets up and maintains analytical instrumentation.
- Trains on routine operation, maintenance and theory of
analytical instrumentation, SOPs and regulatory procedures and
guidelines.
- Ensures QA findings are addressed appropriately.
- Aids and training to other team members.
- Problem solving, either independently or with assistance
pertaining to extraction and/or instrumentation problems.
- Communicates project status to project leader.
- Performs work assignments accurately, and in a timely and safe
manner.
- Reviews, interprets, and analyzes data for technical, quality
and compliance to protocols, methods, SOPs, client criteria and
Good Manufacturing Practices (GMP) or Good Laboratory Practices
(GLP).
- Performs self and peer review of the data for accuracy and
compliance with reporting requirements prior to submission to QA
and issuance to customers. Keys to Success: Education Bachelor's
degree or equivalent and relevant formal academic / vocational
qualificationPrevious experience that provides the knowledge,
skills, and abilities to perform the job (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. Knowledge, Skills, Abilities
- Demonstrated knowledge of LCMS, GCMS AND GMP
- Proficient in Microsoft Excel and Word
- Proven ability to interpret data by performing trend
analysis
- Proven ability in technical writing skills
- Ability to independently optimize analytical methods
- Proven problem solving and troubleshooting abilities
- Good written and oral communication skills
- Time management and project management skills
- Ability to work in a collaborative work environment with a team
Work Environment Thermo Fisher Scientific values the health and
wellbeing 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.
Keywords: Thermo Fisher Scientific, Madison , Scientist II - Extractables and Leachables, Other , Middleton, Wisconsin
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