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1+ months

Refernce Standard Coordinator

Kelly Services
Greenfield, IN 46140
**Reference Standard Coordinator**


**REMOTE POSITION**


Responsible for the strategic and technical oversight of corporate reference standard materials used at Elanco. The Reference Standard Coordinator ensures a consistent high-quality supply of reference standards by working with internal and external partners to source and characterize various chemical and biological entities for application as reference materials. This role will be responsible for driving continuous improvement and operational efficiency through the identification and implementation of new technologies and enhanced capabilities and being responsible for technical leadership across the team. This role will partner closely with R&D to establish new reference standards to support new product development.


Activities include specification and acquisition of source material, inventory management, order fulfillment, design of analytical testing protocols, oversight of third-party testing laboratories, evaluation of characterization data, documentation of technical rationale for decisions, and publication of profile and Certificate of Analysis documentation for reference standards. Will collaborate closely with internal and external testing laboratories, as well as the third-party facility managing the storage, dispensing, and shipment of reference standard materials.


**Job Responsibilities:**


+ Designs, authors, and reviews scientific conclusions and content of documents such as reference standard protocols and profiles

+ Directs the acquisition of information and data related to reference standard source batch materials

+ Looks for opportunities to implement creative and novel solutions.

+ Creates and implements new technologies and capabilities when appropriate.

+ Drives continuous improvement and operational efficiency.

+ Understands the analytical procedures utilized for chemical and biological characterization of pharmaceutical materials and how these tests relate to the molecule analytical control strategies.

+ Assesses and acts on analytical data that are generated to support the characterization and suitability of use of reference standards, including statistical analysis and evaluation.

+ Oversees analytical characterization testing performed at third party laboratories. Identifies appropriate laboratories to perform testing as needed.

+ Understands the proper selection and application of reference standard specifications; participates in the formulation of reference standard specifications

+ Appropriately monitors and manages inventory of reference materials, and performs activities needed to ensure timely resupply of source batch materials

+ Drives decisions regarding establishment and maintenance of reference standards

+ Gains laboratory and molecule technical expert support in resolving difficult laboratory and reference standard issues

+ Drives resolution to obstacles associated with resources, test assignments, and timing associated with laboratory testing

+ Employs detailed analytical problem-solving skills to resolve technical issues with broad impact to the organization.

+ Leads investigations of departures from quality standards

+ Anticipates potential gaps in the existing quality system and acts to present resolutions in a timely and proactive manner

+ Perform any other duties or serve in such other capacity as may be determined by Company management.


**Minimum Qualifications:**


+ Bachelors degree in Chemistry, Biology, Engineering, or other applicable scientific discipline.

+ Strong working knowledge of analytical laboratory operations with a focus on analytical chemistry.

+ Minimum of 5+ years of experience actively working in a pharmaceutical laboratory.


**Skillset:**


+ Ability in managing a variety of processes and projects

+ Ability to drive continuous improvement and implement novel solutions.

+ Experience with analytical characterization of both small and large molecules/biologics.

+ Strong working knowledge in GMP compliance with global regulatory requirements (FDA, MHRA, EMEA, etc.)

+ Previous experience with reference standard characterization and management of reference standard materials.

+ Ability to effectively communicate verbally and in writing

+ Ability to effectively influence remote teams and stakeholders

+ Strong problem-solving skills and decision-making abilities

+ Ability to influence without authority and negotiate positive outcomes

+ Ability to work independently and employ the initiative to find solutions, prioritize and exercise discretion


**Additional Preferences:**


+ Previous experience providing technical oversight of third-party contract laboratory operations.

+ Experience utilizing Veeva QDocs for document management.

+ Experience utilizing Veeva QMS for documentation of deviations and change controls.


**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: 2022-04-18 Expires: 2022-06-18

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Refernce Standard Coordinator

Kelly Services
Greenfield, IN 46140

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