Associate Research Scientist Technical Project Manager (GMP, Biopharmaceutical)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Position : Associate 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 withoutsponsorship. Must 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 :

Responsible for the regulatory and scientific conduct of development validation stability projects and / or other specialty technologies such as extractable / leachable studies. Performs troubleshooting on multiple analytical instrumentation and multiple detection techniques calculates and interprets data and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client. Routinely acts as the technical project leader for multiple projects interacts with clients on a weekly basis (or as needed) to provide updates reviews and evaluates data writes reports and protocols.

A Day in the Life :

Provides technical project management support to external client for commercial program

Independently performs analytical testing method optimization / validation and / or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and / or delivery systems.

Understands and conforms to methods and protocols applicable to assigned tasks.

Designs and performs experiments independently.

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

Prepares and reviews study protocols project status reports final study reports and other project-related technical documents.

Communicates data and technical issues to clients on a weekly basis (or as needed).

Provides technical guidance and training to staff.

Leads analytical (procedural and instrumental) troubleshooting sessions.

Assists in preparation and implementation of SOPs and quality systems.

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 & 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 BS degree plus 6 years of experience or MS plus 5 years of experience or PhD plus 2 years of experience).

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 HPLC CE or iCE strongly preferred

Previous experience with method development qualification and validation preferred.

Previous experience working with external clients or stakeholders

Experience authoring technical documentation including investigations non-conformance methods and protocols preferred

Previous GMP experience preferred

Ability to independently perform root cause analysis for method investigations

Proficiency on technical operating systems

Proven problem solving and troubleshooting abilities

Proven ability in technical writing skills

Time management and project management skills

Good written and oral communication skills

Ability to work in a collaborative work environment with a team

Ability to train junior staff

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 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.

Required Experience :

IC

Key Skills

Laboratory Experience,Machine Learning,Python,AI,Bioinformatics,C / C++,R,Biochemistry,Research Experience,Natural Language Processing,Deep Learning,Molecular Biology

Employment Type : Full-Time

Experience : years

Vacancy : 1