Analytical Development Associate
- Contract
- Analyst
- United States
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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 m.raletz@proclinical.com.
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.
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