Sr. Scientist, Analytical Development and QC, Biologics

Location
San Francisco, CA, United States
Posted
Oct 04, 2019
Ref
3553-394-R
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Position Overview

The Biologics Purification & Manufacturing team is looking to hire a Sr. Scientist, Biologics Purification.

Summary:

Nektar biologics CMC organization is seeking a highly motivated and experienced professional as a Senior 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 Products. This position will collaborate closely with internal cross-functional departments such as analytical method development/chacterization, process development, manufacturing operation, quality assurance, project management and regulatory to achieve corporate goals and objective. This position will also require to work closely with multiple external contract organizations including CMOs and Contract Laboratories (CLs) in the areas of method transfer, qualification/validation and implementation of QC methods for release and stability studies.

The successful candidate will 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 products. A self-starter with the ability to work independently under minimal supervision, and who is seeking 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:

  • Oversight and management of CRO/CMO engaged in AD and QC activities. Provide technical review of analytical data integrity and laboratory documentation, method development reports and method validation protocols/reports.
  • Author, update, and revise CMC regulatory filing sections to support regulatory filings. Address CMC comments regulatory responses.
  • Ensure compliance with cGMP in a manufacturing environment 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.
  • Perform 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:

  • Master's degree in Chemistry, Biochemistry or a related life science field; PhD degree is highly desirable.
  • Working experience with a minimum of 8 years in an Analytical Development and GMP environment (Pharmaceutical or Biotechnology industries) with working knowledge in Quality control activities.
  • Technical expertise in protein chemistry and analytical chemistry, and in the development and implementation of general analytical and protein analytical methods.
  • 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 a tight timelines.
  • Excellent interpersonal and a team player with excellent verbal communication skills and the 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.
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.