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Principal Scientist of Analytical Development

Kelly Services

San Mateo, CA
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Job Details

Job Title Principal Scientist of Analytical Development

Jobid US15TPCH_BH1430272

Location: San Mateo, CA, 94403, USA

Description **Position: Senior Scientist/Principal Scientist of Analytical Development**


Associate Director of Analytical Development


San Mateo, CA


Lead and support Analytical Development activities related to analytical method development, structural characterization and comparability assessment for multiple early-stage and late-stage programs


+ Work in a team environment to manage and co-ordinate analytical development activities between contract testing labs, CMO
+ Develop, improve, and implement platform methodology for release/stability and characterization testing for products
+ Manage structural characterization and analytical comparability assessment activities
+ Author and review analytical documents including but not limited to protocols, reports, procedures and certificates
+ Write and review analytical sections in regulatory submission documents (IND, IMPD)
+ Work closely with Quality Control in analytical method implementation, qualification/validation, and transfer. Serve as technical expert to aid in analytical investigations and assay trouble shooting in routine GMP Quality Control testing.
+ Be a key member of the interdisciplinary development project teams.
**Experience, Skills and Abilities**

+ Expertise in Mass spectrometry, chromatography (e.g. SEC, RP-HPLC, IEX), and capillary electrophoresis (e.g. icIEF, CE-SDS) techniques for protein therapeutics
+ Experience with structural characterization of both large and/or small molecules
+ Experience in analytical assay development and qualification/validation for GMP quality control testing
+ Experience with antibodies, highly potent cytotoxic active pharmaceutical ingredients and/or antibody drug conjugates is a strong plus
+ Hands-on experience with outsourcing of assay development, stability and quality control in support of CMC activities
+ Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions
+ Excellent communication skills for both written and verbal presentations
+ Strong and proven leadership capabilities
+ Self-motivation, enthusiasm and ability to interact within a multi-disciplinary team across multiple locations.
+ Ability to articulate issues to management in a timely manner
+ Experience in working in entrepreneurial stage companies
+ Demonstrable ability to work proactively and independently, tenacious when necessary.

+ Self-motivated, goal driven with a pragmatic, hands-on approach.
+ Positive, professional team member
+ Strong organizational skills
+ High quality standards
+ Excellent oral and written communication skills.
+ Creative problem solving skills.

+ The qualified candidate will possess a PhD in Biochemistry, Chemistry or related disciplines with at least 5 years of industry experience or a BS/MS degree with at least 10 years of industry experience in (bio-) pharmaceutical manufacturing and testing

+ Negotiable based on experience.
**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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