Senior AR&D Scientist Job Listing at Kelly Services in Allegan, MI (Job ID 8906795)

Description

Kelly Science & Clinical has a new, extended temporary opportunity for a Senior Analytical R&D Scientist in Allegan, MI! Contract is slated to last ~4 years with the possibility to be extended.

Day to Day Responsibilities:

• Research, prepare and review technical documents that evaluate physicochemical equivalence between existing sources and proposed alternate sources. Documentation includes, but is not limited to, SOP's, drug master files, vendor qualification, technical packages, compendia, protocols, raw material and intermediate specifications, test methods, certificates of analysis, analytical reports, and method validation reports which conform to company and regulatory standards.
• Perform physical and chemical testing on raw materials. This includes documentation, report writing and review.
• Develop, validate, and transfer non-complex and complex analytical methods.
• Prepare documents for regulatory filings (ANDA, NDA, ANDS) and internal company use.
• Design experiments and provide relevant data to support responses for FDA minor deficiency letters.
• Participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions and successfully resolve problems with suppliers, methods, project issues and deviations.

Qualifications:

• Bachelors degree or higher in Chemistry or Pharmaceutical Sciences combined with at least 6-8 years of relevant experience in a cGMP or cGLP laboratory. 
• Experience in raw material analysis and familiarity with DMFs preferred.
• Demonstrated proficiency in a variety of analytical instruments and software utilized for physical and chemical analysis.
• Familiarity with a variety of compendial references including United States Pharmacopeia.
• The ability to develop, document and execute analyses or experiments of moderate complexity, ensuring methods are robust and reliable.
• The ability to maintain high quality documentation, analyze and properly interpret data, and prepare reports, SOPs or other technical reports is necessary.
• Technical writing and data analysis skills highly desired.
• Must be able to work independently on multiple concurrent projects, develop testing plans that significantly contribute to process and material knowledge, discern specification and testing criticality and communicate effectively with cross-functional teams.

Pay: $100K – $110K/yr – more possible and based on experience
Hours: 8AM – 5PMEST, M-F

For more information or to be considered, please contact me directly at Tierra.Barbour@kellyscientific.com or at 804-991-0745.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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