Kelly Services Chemist - Method Development in Maple Grove, Minnesota
Chemist – Maple Grove, MN
Kelly Scientific Resources is currently seeking candidates for a Chemist for one of our top clients in Maple Grove, MN. This is an open-ended contract, 6-12 months, potentially longer term. Schedule is Monday-Friday 1st shift.
As a Chemist placed with Kelly Scientific Resources, your primary responsibilities will include development and validation of various analytical tests with limited oversight. Also responsible for performing routine testing, as needed.
Additional Job Responsibilities:
Responsible for development and validation of assigned analytical methods such as assay and impurities/degradation products, residual solvents, cleaning verifications, content/blend uniformity and dissolutions. Writes method development reports to summarize development activities, protocols to outline and justify study plans, and validation reports to analyze results and draw appropriate conclusions.
Performs analytical testing according to established or preliminary methods such as cleaning validations, stability samples, dissolutions, assay, impurities/degradation products, content/blend uniformity, pH, viscosity, titrations, general USP testing, residual solvents and other analytical methods
Applies expertise in analytical instruments such as HPLCs, GCs, UVs, dissolution apparatus and automated titrates and actively solves instrumentation issues and assists others with instrumentation startup and troubleshooting.
Reviews peer documentation such as notebooks and other raw data ensuring that it is scientifically sound, meets cGMPs, and will be acceptable during FDA audits.
Reads understands and follows the current USP/NF, laboratory SOPs, analytical methods and study protocols. Applies ICH and FDA guidelines to analytical method development and validations.
Assists with establishing specifications for APIs, excipients and drug products. Develops justification of these specifications to be included in regulatory submissions.
Documents equipment usages and analytical results in a manner that is consistent with cGMP, in-house SOPs, and can be readily followed by reviewers.
Critically reviews and evaluates stability data. Establishes trends between multiple studies. Recommends and assists with establishing the shelf life for new drug products
Documents with clear purposes, sequences and conclusions per GMPs. Takes ownership to assigned work and critically reviews it prior to distribution within the functional group or to cross-functional project teams.
Is able to describe a testing challenge and present supporting data effectively in either a 1:1 or a small group setting.
Reviews raw data timely and ensures it meets cGMPs and in-house SOPs, is scientifically sound and can be readily followed by auditors.
Maintains personal and shared work space in an organized manner. Cleans laboratory glassware and actively participates in lab-wide routine clean up and inspection activities.
Identifies potential training, efficiency, compliance and and/or safety concerns and brings solutions to management. Actively participates in and leads the implementation of continuous improvement efforts associated with laboratory operation.
Leads projects and/or studies within CAS. Provides regular written and/or verbal updates on the projects of assigned initiatives. Ensures that projects/studies are completed according to established timelines.
Ensures that analytical laboratory functions (e.g. methods and validations) of the CMC submission are completed according to ICH/FDA guidelines. Coordinates the gathering of necessary documents and assists with writing portions of the CMC submission document.
Demonstrates cooperation and professionalism with all members of the organization.
Bachelor’s or Master’s degree in Chemistry or related field
Solid working knowledge of either Chromatography (HPLC and GC) or Dissolution testing is required. Experience with both is preferred.
5+ years of GMP lab experience, preferably in the pharmaceutical industry
2+ years of experience with analytical method development and validation in a cGMP lab environment, PC's, cGMP's, and USP testing.
Advanced knowledge of FDA and ICH guidelines.
Strong verbal and written communication skills.
Ability to work independently, with others and to multitask.
Proven problem solving, communication and technical skills
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group- rate insurance options available immediately upon hire*
*Available for purchase and administered by a designated third-party vendor
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm