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Scientist (Analytical Development and QC, Biologics)

Employer
Nektar Therapeutics
Location
San Francisco, CA, United States
Start date
Aug 22, 2020

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Discipline
Information Technology, Science/R&D, Biotechnology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Position Overview

Nektar's Biologics CMC organization has an exciting opportunity for a motivated and experienced Scientist of Analytical Development, Quality Control and CMC.

Nektar's Biologics CMC organization has an exciting opportunity for a motivated and experienced Scientist of Analytical Development, Quality Control and CMC. The ideal candidate has demonstrated knowledge in Analytical Development of biologics and familiarity with PEGylated Drug Substance and Drug Product. This position will collaborate closely with internal cross-functional departments with representatives from bioassay development, analytical method development/characterization, process development, manufacturing operations, quality assurance, project management and regulatory affairs to achieve corporate goals and objective. This position will also require working closely with multiple external contract organizations including CMOs and Contract Laboratories in the areas of method transfer, qualification/validation and implementation of QC methods, with focus on plate-based and cell-based potency methods for lot release and stability studies.

The successful candidate must be proficient in biological assay development (ELISA and cell-based) and be proficient in Quality Control execution and systems, stability study programs, method development/qualification/validation, and end to end CMC regulatory drug approval process for biologic drug substances and drug products. We seek a self-starter with the ability to work independently under minimal supervision, and who is looking to be part of an authentic, innovative and fast-paced team. The ideal candidate will be instrumental in bringing the company's therapeutic products from early-discovery development stage to commercial launch and be a critical part of creating an innovative team for the development of the company's next generation products.

Responsibilities:
  • Work closely with the method development team and provide strategic guidance on potency method selection, development, qualification/validation, technical transfer and troubleshooting.
  • Manage specification setting and stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines.
  • Oversight and management of contract testing organizations engaged in analytical development and quality control activities.Provide technical review of analytical data integrity and laboratory documentation, method development reports and method qualification/validation protocols and reports.
  • Author, update, and revise CMC sections to support regulatory filings. Address CMC comments in responses from regulatory agencies.
  • Ensure compliance with cGMP such that the products are assessed to agreed-upon specifications in a timely manner in order to support in-process, lot release and stability testing.
  • Participate in deviation investigations and CAPA implementation in support of CMC QC projects and improvement.
  • Support inspections/audits (regulatory and internal) and draft audit observation responses.
  • Proactive engagement to identify projects and areas for continuous improvement purposes.
Requirements:

A PhD in a scientific discipline with a minimum of 2 years work experience in a research and/or development environment is required. Exceptional non-PhDs with equivalent experience and demonstrated capabilities in the biotechnology or pharmaceutical industries may also be considered. Post-doctoral work may serve as experience. Working experience in analytical development and/or GMP testing with primary focus on the development, tech transfer and qualification/validation of bioassays (including, but not limited to, ELISA, enzyme activity, cell-based potency methods, qPCR, etc) is essential.
  • Technical knowledge in protein chemistry and analytical chemistry, and in the development and implementation of general and protein-specific analytical methods is highly desirable.
  • Excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrix environment.
  • Proficient in project and personnel management, excellent organizational skills, and the ability to work on multiple projects with tight timelines.
  • Excellent interpersonal and verbal communication skills, and with ability to influence and liaise in a dynamic cross-functional matrixed team environment.
  • Proficiency in MS Office, Word and Excel - Proficiency in statistical analysis software is desirable.
Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices. Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self contained breathing apparatus) for certain tasks essential to the job function. Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

Company

Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.

Stock Symbol: NKTR

Stock Exchange: NASDAQ

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Company info
Website
Phone
415-482-5300
Location
455 Mission Bay Blvd South
San Francisco
California
94158
United States

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