Scientist (Analytical Development and QC, Biologics)

Location
San Francisco, CA, United States
Posted
Aug 22, 2020
Ref
5203-395-R
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.