Associate Research Scientist - Technical Project Manager

Thermo Fisher Scientific; Middleton (WI); On-site; USD 60,000 - 90,000; Full time

Job summary

Join a forward-thinking company dedicated to making the world healthier, cleaner, and safer. As a key member of the laboratory team, you'll lead projects that enhance patient health through innovative scientific solutions. With a focus on quality and accuracy, your expertise will drive significant advancements in clinical research. This role offers the chance to engage with external clients, manage analytical testing, and mentor junior staff in a collaborative environment. Embrace the opportunity to make a real impact in the scientific community while advancing your career in a supportive workplace.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• 6+ years of experience for BS, 5+ for MS, or 2+ for PhD.

Responsibilities

• Manage regulatory and scientific projects for development and validation.
• Perform analytical testing and method optimization independently.
• Communicate technical issues and updates to clients regularly.

Skills

HPLC

CE

iCE

ELISA

Root Cause Analysis

Technical Writing

Project Management

Problem Solving

GMP Compliance

Communication Skills

Education

Bachelor's Degree

Master's Degree

PhD

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence 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

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:

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

• Bachelor's 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, iCE or ELISA strongly preferred

• Previous experience working with external clients or stakeholders

• Experience with quality investigations and technical documentation generation (protocols and methods) strongly 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 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

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