Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Job Title: Scientist II
Department: Biopharmaceutical
Location: Middleton, Wisconsin - GMP Lab
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:
The Scientist role involves conducting complex analyses with a thorough understanding of laboratory procedures and increasing independence. This includes performing intricate sample preparation and analysis to quantitatively measure pharmaceutical and biopharmaceutical compounds across various formulations and biological matrices. The Scientist follows validated or experimental analytical procedures with occasional direct supervision, reviews and compiles results, and compares data against SOP acceptance criteria, methodologies, protocols, and product specifications. Additionally, the role requires entering data into databases and reports, as well as performing self-review of 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 qualification
Experience
Previous 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
Previous experience with biopharmaceutical lab testing preferred
Proficient in Microsoft Excel and Word
Proven track record to interpret data by performing trend analysis
Proven track record 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
Benefits
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
We provide comprehensive benefits including comprehensive training, annual incentive plan bonus, medical, dental, vision, pharmacy, employee assistance program, wellness program options and more!
Other benefits include:
401k with matching contributions, life insurance, long term and short term disability insurance, flexible medical and dependent care spending accounts.
Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holiday.
Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.
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.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
