Associate Research Scientist - Technical Project Manager - Method Development & Validation (HPLC/CE/ELISA)

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 guides. As the world leader in serving science, our laboratory professionals bring their dedication to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

As an Associate Research Scientist you will conduct and provide technical mentorship on routine stability testing for our cell lab. You will perform troubleshooting for your own and others instruments, methods, procedures. You will interpret and review analytical data for self and others as well as assists others in performing routine maintenance and troubleshooting on multiple instruments and multiple detection techniques, methods and procedures. You will routinely act as the technical project leader for multiple projects, provide updates, review and evaluate data, and write reports and protocols.

A Day in the Life:

• Independently performs analytical testing 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 executes experiments independently.
• Prepares, reviews and critiques 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 and 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 6+ 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:

• Previous experience with HPLC, CE, ELISA
• Previous experience in GMP lab preferred
• Previous method development and validation experience preferred
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
• Full knowledge of technical operating systems
• Ability to independently optimize analytical methods
• Ability to independently perform root cause analysis for method investigations
• Proven technical writing skills
• Proven problem solving and troubleshooting abilities
• Effective written and oral communication skills as well as presentation skills
• Time management and project management skills
• Ability to mentor others on technical operating systems
• Ability to independently review and understand project proposals/plans
• Ability to work in a collaborative work environment with a team

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.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office