Senior Research Scientist Technical Project Manager (GMP)

Work Schedule

Environmental Conditions

Job Description

Position: Senior Research Scientist - Technical Project Manager

Location: Middleton Wisconsin

Department: Biopharmaceutical

This is a fully onsite role based at our GMP Laboratory in Middleton WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States be able to pass a comprehensive background check whichincludes a drug screening.

At Thermo Fisher Scientific youll 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:

As a Senior Research Scientist you will serve as a technical program lead supporting complex client programs within a GMP laboratory environment. This role has both routine and non-routine impact providing scientific oversight across multiple programs while leading technical aspects of client onboarding complex investigations and program execution.

You will interact directly with clients to deliver technical updates and recommendations review data and documentation and act as a key technical resource for project teams. Additionally you will mentor junior scientific and project staff helping to build technical capability and ensure consistent high-quality execution across programs.

Key Responsibilities:

• Independently plans and guides the scientific approach for analytical methods method transfers and specialty technology studies ensuring alignment with client requirements program phase and GMP expectations.

• Acts as an on-site Subject Matter Expert (SME) for assigned instrumentation analytical techniques or technology platforms providing scientific guidance to project teams and supporting issue resolution.

• Mentor and train junior scientists and TPMs supporting development of technical understanding scientific decision-making and confidence in client interactions.

• Evaluates available technical options to acquire desired quality of analytical results economics ease of introduction into a production environment and adaptability in analytical applications.

• Demonstrates viability of in-house developed methods and methods transferred from clients by crafting appropriate validation experiments or other appropriate aspects of specialty methodology or technology.

• Lead client discussions regarding project definitions technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.

• Reviews protocols project status reports final study reports and other project related technical documents.

• Assists business development group in technical sales and marketing and in preparation of technical marketing materials and presents posters and makes podium presentations at conferences.

• Leads in preparation and implementation of SOPs and quality systems as well as developing innovative technology and in evaluating and implementing new capabilities.

• Reviews interprets and analyzes data for technical quality and compliance to protocols methods SOPs client criteria and Good Manufacturing Practices (GMP). 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 and Experience:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 10 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 and Abilities:

• Proven ability to troubleshoot complex analytical or technical issues in a GMP environment strongly preferred

• Experience mentoring or training junior staff

• Excellent written and verbal communication skills including the ability to engage directly with clients.

• Knowledge and application of industry best practices not yet represented by global regulatory requirements

• Full theoretical and hands-on understanding and knowledge of general chemistry and separation science

• Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations

• Full understanding of laboratory requirements SOPs ICH guidelines USP requirements and FDA mentorship

• Ability to independently review and understand project proposals/plans

• Proven track record in technical writing skills

• Ability to work in a collaborative work environment with a team

• Ability to independently optimize analytical methods

• Time management and project management skills

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 100000 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!

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-*. 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.