23 days old

Senior Scientist -Analytical Tech Transfer

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking a Senior Scientist - Analytical Tech Transfer in Gaithersburg, MD to work a contract assignment of 6 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities of the** Senior Scientist -Analytical Tech Transfer **includes:**

Title: Senior Scientist - Global Technical Operations - Analytical

Position Description:

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

Essential Job Functions:

+ Responsible for analytical method transfer from the companys Biopharmaceutical Development or Global Technical organization to commercial manufacturing sites as well as outside testing laboratories

+ 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

+ Foster creative collborations between R&D, Operations and the third-party suppliers to progress the projects and coming up with win/win solutions

+ 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

+ Provide forward thinking in anticipation of future needs

Position Qualifications:

+ Experience in cell culture, Immuno assay, PCR, next generation genome sequencing, biologics, residuals and impurities assay, analytical method development, transfer and method validation- Vaccine experience preferred. Leadership experience in leading global team and working with CMO is essential

+ Must have significant experience with most of the following standard analytical techniques used in the biopharmaceutical industry: e.g., UV-Vis, HPLC, LC-MS, GC, FT-IR, SDS-PAGE, IEF, CE, ELISA, mass spectrometry, bioassay.

+ Has a working knowledge of biosafety testing and microbiology requirements in a manufacturing environment

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

+ Leadership experience in leading global team and working with CMO is essential

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

+ Ability to manage complexity and adapt to changing priorities

+ Has demonstrated leadership through project team participation, internal consulting and mentoring

+ 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 and Experience Requirement of the** Senior Scientist -Analytical Tech Transfer **includes** :

+ MS or PhD in Biological Sciences required

+ 10-12 years relevant experience with a MS

+ 6+ years relevant experience with a Ph.D.

**Additional Information:**

+ Contract assignment, duration 6 months.

+ Work schedule: full-time, first shift.

**Kelly Temporary Employee Perks:**

+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts

**Apply Now!**

This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:

Please email your resume directly to Sandy at: [reference Bh Job #3100023]

Thank you for your interest in the assignment.

**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-10-02 Expires: 2020-11-02

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Senior Scientist -Analytical Tech Transfer

Kelly Services
Gaithersburg, MD 20898

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