Immunoassay Method Development and Validation Group Leader

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)

Job Description

Position : Group Leader

Location : Richmond VA

Department: ICD Research and Development

Shift: First Shift - Monday - Friday 8AM - 5PM EST

Full time Benefits Annual Bonus 401k Match and PTO

This is a fully onsite role based at our BIOA Laboratory in Richmond VA. 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 screen.

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:

The Group Leader performs immunoassay method development validation and troubleshooting in support of pharmacokinetic toxicokinetic pharmacodynamic and immunogenicity (ADA) sample testing involving novel therapeutics (particularly large-molecule biologics) in the pharmaceutical industry.

A day in the Life:

• Independently performs immunochemistry laboratory experiments and acts as the technical project leader for multiple projects. Designs and executes experiments reviews and analyzes data writes reports and other technical documents with minimal supervision.
• Interacts with clients around technical data scientific issues and project status. Responds to client needs. Mentors trains and coordinates laboratory activities of other team members to achieve project goals within established project timelines.
• Ensures high-level science quality and compliance to protocols methods SOPs client criteria Good Laboratory Practices (GLP) and regulatory guidance. 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

• Bachelors degree in lab sciences such as biology biochemistry immunology chemistry molecular biology or similar

Experience

• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 8 years) or equivalent combination of education training & experience.
• OR Masters degree and previous experience that provides the knowledge skills and abilities to perform the job (comparable 6 years)
• OR PhD (comparable to 4 years)
• 1 year of leadership responsibility

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

• Solid understanding and knowledge of biology chemistry and immunoassay techniques.
• Knowledge of immunoassay platforms such as ECL ELISA NULISA and Gyrolab.
• Knowledge of cell therapy gene therapy and oligonucleotide bio analysis is a plus.
• Full understanding of laboratory requirements PPD & client SOPs ICH guidelines USP requirements and FDA guidance
• Experience working within a Contract Research Organization (CRO)
• Ability to utilize Microsoft Excel and Word to perform tasks
• Proficiency on technical operating systems
• Proven problem solving and troubleshooting abilities
• Effective oral and written communication skills
• Proven ability in technical writing skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team
• Ability to train and mentor junior staff

Working 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.

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