Description:

Associate II, Analytical Development to provide technical and documentation support in a laboratory setting. This role is responsible for contributing to the method development, qualification, and technology transfer for analytical methods. The qualified individual will bring experience in relevant analytical technologies, such as ELISA, SRID, Luminex, or BLI. The position will perform in-process testing, as needed, to support the Process Development, Formulation Development, and Manufacturing teams, in addition to method development and qualification.

Responsibilities include but are not limited to:

Perform routine analytical testing of in-process samples to support other functional groups

Participate in design and execution of method development, qualification, and technology transfer into the Quality Control team or external testing teams, as needed

Write, review, and edit standard operating procedures, test methods, protocols and reports

Analyze and present scientific data to internal and external meetings

Utilize design of experiment (DOE) and other statistical data analysis to support a quality by design approach to method lifecycle

Keeps accurate testing records and assures that laboratory equipment has been calibrated, standardized, and monitored as appropriate

Assists in the maintenance of the lab including routine housekeeping activities

Other duties as assigned

Additional Skills & Qualifications:

Minimum Requirements:

Bachelor’s degree with at least 1-2 years of experience OR Master’s degree with some industry internship or co-op experience.

Knowledge of analytical immunoassay methodologies, such as ELISA, SRID, VaxArray, Luminex, or BLI

Experience with Method Qualification, Technology Transfer, and Validation of analytical methods per ICH guidelines is a plus

Experience in statistical data analysis and design of experiments (DOE) in JMP or equivalent software is a plus

Strong verbal and written communication skills

Exemplary multi-tasking and organizational skills

Strong team player

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.