Senior Scientist 9/2/2020
JOB DESCRIPTIONAPPLY SENIOR SCIENTIST is needed for a CONTRACT opportunity for Yoh Scientific's client located in Gaithersburg, Maryland. The client is a multinational pharmaceutical and biopharmaceutical company. If you are interested and meet the requirements, please send a Word copy of your resume to Kelly.Hua@yoh.com.
TITLE: SENIOR SCIENTIST - GLOBAL TECHNICAL OPERATIONS - ANALYTICAL POSITIOn
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 activities in Operations, which include the following functions.
* Responsible for analytical method transfer from 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 collaborations 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: KNOWLEDGE AND SCOPE
* 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
* MS or PhD in Biological Sciences required with 10-12 years relevant experience with a MS or 6+ years relevant experience with a Ph.D.
Opportunity is Calling, APPLY NOW!
RECRUITER: Kelly Hua
WHAT'S IN IT FOR YOU*
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
* Medical, Dental & Vision Benefits * 401K Retirement Saving Plan * Life & Disability Insurance * Direct Deposit & weekly ePayroll * Employee Discount Programs * Referral Bonus Programs
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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here:
to contact us if you are an individual with a disability and require accommodation in the application process.