Senior Scientist, Drug Substance & Manufacturing - Redwood City, CA | Biospace
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Senior Scientist, Drug Substance & Manufacturing

Relypsa Inc.

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Location:
Redwood City, CA
Posted Date:
11/2/2016
Position Type:
Full time
Job Code:
391
Salary:
DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Company Overview

Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company.  More information is available at www.relypsa.com.

Product Overview

Veltassa® (patiromer) for oral suspension was approved in October 2015 for the treatment of hyperkalemia, a condition defined as elevated blood potassium levels that can cause abnormal heart rhythms and even sudden death. A potassium binder, Veltassa® is the first new medicine for the treatment of hyperkalemia in more than 50 years and is the first commercialized medicine resulting from Relypsa’s polymer technology platform. Relypsa is committed to ensuring that people living with the burden of hyperkalemia have access to Veltassa®.

Position Overview

Responsible for synthetic route selection and evaluation, process research and development, process optimization and scale-up of synthetic processes for new Drug Substances from gram to multi-kilogram scale. Applies advanced subject matter knowledge to complex business issues and is regarded as a subject matter expert.  Frequently contributes to the development of new ideas and methods.  Works on complex problems/projects where analysis of situation or data requires an in-depth evaluation of multiple factors.  Exercise significant independent judgment within broadly defined policies and practices to determine best method for accomplishing work and achieving objectives.  Leads and/or provides expertise to functional project teams and may participate in cross functional initiatives.  May provide mentoring and guidance to lower level employees.  Acts as an expert providing direction and guidance to process improvements and establishing policies.  Frequently represents the organization to external customers/clients.


Responsibilities:

•   Performs laboratory experiments in the areas of route selection, process research and development, process optimization
•   Serves as department representative on Development project teams
•   Prepares relevant sections of CMC regulatory submissions
•   Works on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables.
•   Exercised independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
•   Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways
•   Manages contract research and manufacturing organizations conducting activities directed toward the development of Relypsa Investigational New Drug Substances.
•   Maintains familiarity with current scientific literature relevant to the research experiments or program
•   Incorporates new information into the planning process for the assigned research project.
•   Interacts and collaborates with internal groups and departments to discuss and resolve program and/or department needs
•   Provides supervision, training, technical support and career development coaching to direct reports; assists direct reports in planning experiments and analyzing data.
•   Participates in setting the goals of the program and/or project with understanding of priority and impact to organization.
•   Maintain laboratory notebook in a complete, consistent and concise manner in accordance with company intellectual property policies and practices.
•   Complies with company health and safety policies and general laboratory practices.

SUPERVISORY RESPONSIBILITIES:

•   Directly supervises employee(s).
•   May indirectly supervise employee(s) through a dotted line structure or via other subordinate supervisors.

Requirements

•   BA/BS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline, and at least 10 years of experience in the pharmaceutical industry, or advanced degree (MS/MA, PhD) in plus 8 years of experience in the pharmaceutical industry
•   Experience working in a pharmaceutical/cGMP environment
•   Extensive experience in a polymer chemistry, synthetic organic chemistry or chemical engineering
•   Experience in the development of synthetic compounds and/or manufacturing processes, interpretation of data to support synthesis and/or process, and characterization of material produced
•   Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.
•   Understanding of Design of Experiments (DOE) and Quality by Design (QbD) principles.
•   Excellent written and verbal communication skills.
•   The ability to interact and effectively share process development details, and development knowledge with cross functional areas.
•   Experience with scale-up and hands-on knowledge of larger scale chemical synthesis
•   Independently solves complex problems.
•   Participates in customer interaction at company site, during visits or professional meetings.
•   Initiates active participation on project teams.
•   Interfaces with outside vendors and consultants.
•   General experience working with computers including MS Word, MS Powerpoint and MS Excel required.
•   Extensive knowledge of organic laboratory procedures and the analysis of spectroscopic data including NMR, mass spectrometer, and HPLC.
•   Sets goals with understanding of priority and impact to program, department and organization.
•   Applies advanced scientific and technical principles, theories and concepts. Contributes to the development of new principles and concepts
•   Experience with PAT is preferred
•   Experience with QbD principles is preferred


As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities 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 reflect Relypsa’s high regard for our employees.

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Relypsa is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.