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Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence 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.), Standing for full shiftJob DescriptionCell and Gene Therapy DepartmentMiddleton, Wisconsin, United States of AmericaJob DescriptionAt 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:
Support late phase or commercial client on release and stability projects.
Protocol and method generation, technical support to the team, client communications, nonconformance writing and leading OOS investigations.
Works with multiple functional groups to meet business needs.
Plans and organizes work with periodic supervision.
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.
Qualifications - ExternalKeys to Success:EducationMS degree with 5+ years of experience; BS degree with 6+ years of experience.Experience
Laboratory experience involving Sanger Sequencing and PCR
Method Development and Validation experience
Experience with Release and Stability programs.
Prior client interfacing experience needed.
Experience delivering project completion to timeline.
Teamwork: data sharing, problem-solving, and collaborating.
Knowledge, Skills, Abilities
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
Skilled at written and verbal communication, documenting and sharing experimental methods, data, outcomes, and conclusions to diverse audiences.
Ability to identify issues and adapt experiments on-the-fly, a skill facilitated by strong attention to detail and a willingness to ask for help.
Skilled at prioritization and navigating ambiguity with a positive demeanor.
Work EnvironmentThermo 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.
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 statusThermo 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.