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1+ months

Scientific Director

Kelly Services
St Charles, MO 63303
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a **direct-hire** opportunity to work as a **Scientific Director** based in Saint Charles, MO.


**Job Title: Scientific Director**


**Salary range: 120k**


**This is a direct-hire salaried position + benefits, PTO, and additional company perks**



**Summary:**


The Scientific Director is responsible for overall client interaction and the delivery of the technical portion of bioanalytical studies conducted within the BioPharma Services Laboratory. A technical/scientific leader, who has in-depth knowledge and specific understanding of all the processes related to bioanalysis. Provides strategic direction to the project teams, and supports the Bioanalytical Business Unit and Management.


**Essential Duties and Responsibilities:**


+ Serves as a single point of contact for Study Directors and clinical team for bioanalytical projects

+ Consults with clients on method transfers and validation needs and establishes appropriate immunochemistry assays or programs

+ Provides Business Development with scope of work, estimates of time required to complete the project and level of technical challenges for use in proposal preparation

+ Establishes the design and manages the conduct of studies in compliance with the protocol/amendments/planned changes, SOPs, and all applicable regulatory requirements; i.e., GLP, GCP, ICH, etc.

+ Provides scientific leadership and directs staff responsible for the scientific conduct of immunochemistry method transfer and validation projects and sample analysis projects

+ Interacts with Sample Analysis Team to provide efficient transfer of analytical methods and reagents post validation

+ Organizes and communicates complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds

+ Reviews and approves reports, or reporting of results, within study timelines, and ensures any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate


+ Responsible for engaging key stakeholders for troubleshooting problems with analytical methods that may arise


+ Technical writing in the form of validation plans, reports and other related documents, as needed

+ Demonstrates and promotes the company vision

+ Regular attendance and punctuality

+ Apply GMP/GLP/GCP in all areas of responsibility, as appropriate and understands and follows all written procedures that apply to the function of the position

+ Collaborate across departments to complete projects

+ Performs other duties as assigned


+ May supervise team members within work group


**Skills**


+ Candidate should be a strong team player with excellent oral and written communication skills and with a demonstrated ability to interpret data, troubleshoot, and suggest next steps.

+ Demonstrated experience to interact successfully with clients

+ An understanding of international regulatory requirements including MHRA and FDA essential

+ Broad expertise in current regulatory guidance documents and white-papers applicable to bioanalysis and attend scientific and business meetings.

+ Strong leadership skills and ability to work independently and supervise people in order to manage multiple projects and priorities in a matrix environment.

+ Appropriate technical experience of relevant laboratory techniques within a regulated environment

+ As deemed appropriate based on the individuals experience, training, and study design, the candidate may be asked to act as:

+ "Manager of Analytical Team,"

+ "Person Responsible" or "Principal Investigator" or Scientific Director for studies claiming compliance with GCP/GLP regulations and / or ICH guidelines or bioanalytical studies that do not officially fall under these categories but require regulated oversight.

+ Demonstrated ability to work independently and without instruction for routine work

+ Experience working in an operational environment to deliver data and reports in an effective and efficient manner

+ Demonstrated leadership skills, including mentoring/coaching of staff

+ Experience within a contract research organization desired

+ Excellent verbal, written and interpersonal skills, including the ability to work cross-functionally with other departments

+ Excellent ability to complete tasks within agreed timelines

+ Demonstrated proactive problem-solving and decision-making ability

+ General understanding of business principles and typical business practices

+ Demonstrated proficiency with personal computer software in a business environment, specifically with email, word processing, and spreadsheet applications, as well as the aptitude for learning functionally related software. Microsoft Office preferred.

+ Process Excellence Experience

+ Project Management Experience desired


**Qualifications**


+ A Ph.D. or Masters degree in a biological science preferred, or equivalent combination of education and experience

+ At least 5 years relevant experience in pharmaceutical industry or similar

+ Ligand binding assay development

+ Drug development in contract services


\#TJP2021_SPEC


**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: 2021-07-26 Expires: 2021-10-07

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Scientific Director

Kelly Services
St Charles, MO 63303

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