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1+ months

Scientist I, II, or III

Kelly Services
Gainesville, GA 30501
**Scientist I, II, or III**


Kelly is hiring looking for a Scientist II Analytical Development. This is a direct hire opportunity located in Gainesville, GA. In this role you will support early-stage product development through commercialization. You will focus on method development and validation for solid oral dosage analytical testing, including writing and revising SOPs, analytical procedures, and other documentation. In addition, you will perform method transfer routine analytical testing, and equipment purchase and qualifications.


**Responsibilities**


+ Accountability for the execution of analytical deliverables, communicating project obstacles to leadership and internal stakeholders.

+ Be the primary technical interface with clients during meetings and teleconferences.

+ Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation.

+ Develops analytical methods for dissolution and chromatographic analysis.

+ Resolves technical issues and interprets and uses experimental data to expand on assignments whenever possible.

+ Evaluates and interprets test and experimental data, draws conclusions based on results, and documents and communicates work appropriately.

+ Documents laboratory activities including notebook/worksheet, electronic notebook, and LIMS entries according to procedures that define laboratory documentation practices.

+ Performs controlled substance chain of custody documentation and reconciliation.

+ Troubleshoots technical procedures, methodology and instrumentation.

+ Authors/reviews validation and method transfer protocols.

+ Acts as subject matter expert for analytical technology transfer.

+ Authors/reviews laboratory investigations. Conducts investigations, determines root cause and documents results, as needed, in compliance with SOPs.

+ Ensures laboratory reference standards are maintained in compliance with controlled substance and site SOPs and the site EH&S manual.

+ Assists with periodic maintenance/calibration of laboratory equipment.

+ Assists laboratory management with acquisition, upgrade and qualification of instruments.


**Requirements**


+ Bachelors Degree in chemistry or related scientific discipline is required.

+ Minimum of five (5) years of work experience in pharmaceutical or related laboratory work is required. Hands on experience with pharmaceutical analytical method development is highly preferred.

+ Experience writing validation protocols and summary reports, analytical test protocols, SOPs and other technical summary reports is highly preferred.

+ Demonstrates advanced technical knowledge of analytical methods. Working knowledge of GLP/cGMP regulations and safety procedures.

+ Knowledge of Analytical Development operations and ability to support and coordinate projects in various stages of the development process.

+ Good technical writing and communications skills.

+ Good interpersonal skills and ability to work effectively in a team environment and client companies.

+ Demonstrates project management skills. Ability to react quickly to changes in project priorities and timelines.

+ Experience with electronic document management systems (Veeva) and chromatography data management software (Empower/Chemstation).

+ Ability to support multiple projects simultaneously and serve as a senior technical contributor and/or independent project team member. May act as a project team lead.

+ Candidates should demonstrate a general understanding of chromatographic techniques and basic trouble shooting skills for typical High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) related problems.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2022-03-23 Expires: 2022-05-23

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Scientist I, II, or III

Kelly Services
Gainesville, GA 30501

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