Analytical Development Associate

Highly Competitive
  1. Contract
  2. Analyst
  3. United States
Gaithersburg, USA
Posting date: 06 Jun 2024

Analytical Development Associate - Contract - Gaithersburg, Maryland MD

Proclinical is seeking a dedicated and detail-oriented individual for the role of Associate II, Analytical Development.

Primary Responsibilities:

This role involves providing technical and documentation support in a laboratory setting, with a focus on method development, qualification, and technology transfer for analytical methods. The ideal candidate will have experience in relevant analytical technologies and will be responsible for in-process testing to support various teams.

Skills & Requirements:

  • Bachelor's degree with relevant experience or Master's degree with 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.
  • Excellent multi-tasking and organizational skills.
  • Ability to work effectively as part of a team.

The Analytical Development Associate's responsibilities will be:

  • Perform routine analytical testing of in-process samples to support other functional groups.
  • Participate in the 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.
  • Maintain accurate testing records and ensure that laboratory equipment is calibrated, standardized, and monitored appropriately.
  • Assist in the maintenance of the lab, including routine housekeeping activities.
  • Perform other duties as assigned.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267 428 7770 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.