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20 days old

Research Investigator

Kelly Services
Manatí, PR 00674
**Research Investigator**


Supports the technical in-process, release, and stability methods for bulk and/or drug products.

Performs troubleshooting to solve analytical-related problems during in-process, release, and stability testing to determine remedial steps to correctly resume testing, while guaranteeing compliance.

Serves as a liaison between Quality Control and other support groups (e.g. QA, Validation, and Analytical Research) to assure that current laboratory method issues are being properly addressed.

Designs, evaluates, and executes Analytical Method Transfer protocols.

Executes transfer and start up of new and existing methods into the Quality Control ensuring that critical assay parameters are clearly communicated to the receiving site.

Designs, executes and evaluates method development protocols to ascertain the required degree of validation for new and existing methods guaranteeing implementation of a feasible, efficient, rugged, and robust method.

Supports technical aspects of test method ruggedness and robustness processes.

Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control.

Coordinates projects to assure successful and timely execution, issuance and updating of detailed time and event schedules.

Leads analytical special projects to accomplish company goals and objectives on a timely and effective manner .

Evaluates analytical method deviations with respect to their causes and corrective actions to prevent recurrence.

Provides timely and efficient technical reports to document all analytical improvement or investigation projects.

Evaluates and appraises method and instrument changes in regards to regulatory requirements. Keeps current with emerging technologies, new instrumentation, and regulatory expectations relative to the pharmaceutical/development laboratory operations.

Trains Technical Operations analysts to perform existing and/or new analytical methods and generate training documentation as required.

Handles hazardous wastes in a safe manner and maintains a safe work environment. Assures compliance with all accepted laboratory and safety procedures.

Leads analytical technology transfers, making key decisions, which have a significant impact on project outcome.

Verifies consistency with other site procedures and/or specifications.


Requirements:


BS Degree in Natural Science in Biochemistry or Chemistry.

The experienced required based on Degree is:

? BS Degree with five (5) years experience in pharmaceutical industry with at least two (2) years experience in method development/transfer of biomolecules.

? Master Degree with at least (2) two years experience in pharmaceutical industry in method development/transfer of

biomolecules

? PhD Degree with experience in handling, analysis, and method development of biomolecules.

Technical knowledge of proteins handling and analysis with specific experience in biomolecules method optimization and troubleshooting.

Broad experience with analytical instrumentation and techniques (e.g. HPLC, GC, UV, FTIR, MS, CE, SDS-PAGE, SEC, ELISA)

Literacy of pharmaceutical industry analysis of Bulk Products and/or finished dosage forms.

Computer literacy (Microsoft office, etc) and presentation skills (English/Spanish).

Technical writing and oral communication skills (English/Spanish).

Leadership skills, time management, planning and organization capabilities.

Excellent interpersonal skills and the ability to interact with people at all levels

Project management skills

Knowledge of Statistical Process Control, and Design of Experiments with demonstrated analytical and problem-solving skills.

Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-05-31 Expires: 2021-07-01

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Research Investigator

Kelly Services
Manatí, PR 00674

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