19 days old

Remote Senior Scientist - Global Technical Operations

Kelly Services
Gaithersburg, MD 20898 Work Remotely
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Remote** **Senior Scientist - Global Technical Operations** at a prestigious Fortune 500 company.

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the Submit Resume button included within.

**Job Title:** **Remote** **Senior Scientist - Global Technical Operations**

**Pay: $93 per hour**

**Position Summary** :

This position will provide overall scientific and strategic leadership for bio analytical operations network leading strategic analytical projects and supporting Science and Technology Excellence.

**Essential Job Functions** :

Key area of responsibility will be enterprise wide analytical life cycle activities in Operations, which include the following functions.

Responsible for analytical method lifecycle management strategy and execution

Provides overall leadership to analytical method performance monitoring across sites

Develop predictive models and determine the appropriate approaches or techniques to evaluate analytical method issues and potential solutions

Lead analytical method reviews to drive compliance

Serve as a the business process lead for analytical method life cycle management.

Work cross functionally to continuously improve the analytical method capability for biologics

Actively contribute to the preparation of internal audits and regulatory inspections (on-site)

Responsible for developing pragmatic implementation plan, by working with stakeholders from cross functional areas

Responsible for ensuring harmonized compliance to internal standards and policies related to analytical operations supporting third party suppliers

Ensure compliance to internal procedures, Quality Systems, applicable GMP regulations globally, and understand and maintain industry standards.

Responsible for establishing and simplifying process of data analytics employing novel data mining tools.

Author/Review technical documents in the subject matter for regulatory submissions as needed

Provide input and review for regulatory filings to ensure consistency in depth of content and strategic approach

**Position Qualifications** :

Knowledge and Scope

Proficient in Spotfire, SQL, Python, R as well as ability to develop sophisticated visualizations

Experience in developing simple software solutions to complex large data sets

Experience in working with large sets of structured and unstructured data

Understanding of cell culture, Immuno assay, PCR, next generation genome sequencing, biologics, residuals and impurities assay, analytical method development, transfer and method validation

Analytical method development and validation experience; knowledge of cGMP practices and ICH requirements

Ability to work effectively in a team-based environment as well as cross functionally

Ability to manage complexity and adapt to changing priorities

Ability to make timely and defensible decisions and conclusions

Demonstrates the ability to effectively explain complex scientific concepts to a broader, diverse audience.

Proficient in project management and stakeholder management skills

Experience in using Lean/continuous improvement methodology for process improvement

**Education Requirements** :

At least bachelors degree in mathematics or biological or engineering required with 5-10 years relevant experience

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** ( **.**

**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**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. 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. (


Posted: 2021-01-08 Expires: 2021-02-27

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Remote Senior Scientist - Global Technical Operations

Kelly Services
Gaithersburg, MD 20898

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