Santa Clara Categories:
Analytical Development Scientist (SN009) Relypsa
DEPARTMENT: Pharmaceutical OperationsRelypsa will soon be located in Redwood City and we are hiring! We are seeking a reliable, self-motivated professional for the position for a Scientist level in the Analytical Development Group supporting late stage drug development project. The position can be temporary or regular depending on applicable experience.
RESPONSIBILITIES:
Authoring method development reports, validation protocols and reports and related documents to support NDA filing
Performing virtual QC related tasks (review release and stability data, validation data)
Development of highly sensitive methods for impurities identification and quantification as well as reference standard characterization (literature search, devising strategies and exploring state-of-the art analytical techniques)
Evaluation and improvement of existing tests and assays as well as conducting the tests
SKILLS/EXPERIENCE:
Hands-on experience in wide range of state-of-the-art analytical techniques is a must (LC, LC/MS, IC, GC, GC/MS, SEC, IR, NMR, XRD, DSC, TA, Light Scattering) is a must
Hand-on experience with running Waters, Dionex, and Agilent LC and GC instruments and familiarity with Empower, Masslynx, Chromeleon and Chemstation is preferred
Excellent working knowledge of the ICH Guidelines regarding GMP quality and stability testing, method validation and related GMP requirements for Phase 3 and beyond is required
Recent direct experience with writing CMC quality sections for NDA submission is a plus
Involvement in overseeing and ability to build a highly productive relationship with CMO and CRO is a plus
Ability to exercise independent judgment in developing methods and evaluation criteria for obtaining results is desired
Works on complex problems where analysis of situations or data requires an evaluation of intangible variables
Excellent communication, interpersonal and organizational skills for a team-oriented environment, along with the ability to be flexible and collaborate on projects is required
QUALIFICATIONS:
PhD degree in Analytical Chemistry or BA/BS or MA/MS with appropriate work experience (generally at least 5+ years of work experience in drug development environment).
Sustained demonstration of technical proficiency, scientific creativity, collaborations with others and independent thought
Is able to affect results by maneuvering through appropriate formal and informal organization channels ? can reach appropriate resolution in many varied situations
Possesses exceptional ability to analyze and present applicable data
Demonstrates commitment and enhanced efficiency in quantity and quality of work
Additional competencies are demonstrated and evaluated, such as: management effectiveness, decision making and adaptability
NOTE: This job description is not intended to be all-inclusive. Other related duties as negotiated may be assigned to meet the ongoing needs of the organization.
As an employee of Relypsa, you will actively contribute to the development of potential new products. Our pre-IPO status provides opportunity for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and pre-ipo stock options reflect Relypsa?s high regard for our employees. EOE
| Location: | 5301 Patrick Henry Drive Santa Clara, CA 95054 United States |
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Relypsa
All Jobs: at Relypsa| Web Site: | www.relypsa.com |
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| Headquarters: | 5301 Patrick Henry Drive Santa Clara, CA 95054 United States |
| Industry: | Biotechnology |
