Director, Analytical Development

Location
San Francisco, CA, United States
Posted
Nov 18, 2020
Ref
5171-395-2020
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar is seeking a talented, experienced, and highly motivated scientific expert to join our Analytical Development department in support of the company's growing pipeline of therapeutic biologics drugs.

Nektar is seeking a talented, experienced, and highly motivated scientific expert to join our Analytical Development department in support of the company's growing pipeline of therapeutic biologics drugs. The successful candidate will have important leadership roles in the company's growth, with respect to the development of both products and the organization, through expertise in product characterization, analytical method development/validation and IND/BLA document preparation. The position, which will be located at the company's San Francisco, CA headquarters, will also have a significant amount of direct interactions with staff at our Huntsville, AL site, and also with our contract laboratories and contract manufacturing facilities. The individual in this position will serve as a collaborator and a scientific and technical leader on a variety of teams within the company and will represent the company in the same roles during interactions with regulatory agencies, corporate partners and collaborators.

Essential Duties and Responsibilities

Scientific oversight of analytical development for recombinant DNA-derived biologics products (process intermediates, protein intermediate, PEGylated drug substance and drug product), including activities performed internally and at contract facilities:
  • Product characterization
  • Analytical method development, optimization, transfer, and qualification/validation
  • Quality control testing, especially cGMP
Will create and own the strategic plans regarding the development and implementation of methods, techniques, and evaluation criteria. Maintains a current knowledge of state-of-the-art technological, scientific and regulatory trends. Provides scientific/technical guidance, leadership and decision-making across the company, including non-analytical functions, as appropriate. Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives as well as an understanding of the business. Assesses utilization of resources and identifies when, and where additional resources may be needed. Communicates cross-functionally with various departments to ensure appropriate project support. Reviews and approves analytical laboratory documentation, including (but not limited to) technical reports, method transfer/qualification/validation protocols and reports, investigation protocols and reports, stability protocols, certificates of testing/analysis. Serves as the lead author of product specifications as necessary. Collaborates with quality control and stability functions (internal and external) as required to support project teams and functional areas across the company and with external partners. Participates on project teams, product development teams, company initiative task forces, and collaborations with corporate partners as the analytical development SME. Participates in the development of RFP's, review of proposals, and selection of contract facilities, including analytical and manufacturing, as the analytical SME. Reviews and approves manufacturing batch records with respect to sampling plans and analytical testing. Participates in the development of budgets associated with projects, capital equipment and staffing (internal and outsourced). Authors regulatory filing sections associated with analytical characterization and quality control. Establishes goals, structures experiments, analyzes and reduces data, recommends and plans actions to achieve project objectives. Establishes and assures adherence to schedules, work plans and performance requirements. Regularly interacts with senior management.

Minimum Qualification Requirements

A minimum of a Bachelor's degree in a life sciences, chemistry, or engineering discipline is required; an advanced degree is strongly preferred. A minimum of 13 years of experience in the biotechnology and/or pharmaceutical industry is required. A minimum of 10 years of experience in the analytical development of therapeutic proteins or other biologics, with a proven track record of managing and advancing both groups and projects, is required. Expertise in biopharmaceutical cGMP is essential. In-depth familiarity with state-of-the-art analytical techniques to elucidate protein structure and function is required. Experience in developing recombinant DNA-derived therapeutics from both microbial and mammalian sources is highly desired, as is experience in the development of biologics modified with PEG or other molecular entities. A track record in collaboration with representatives across multiple technical functions, including (but not limited to) Process Development, Formulation/Drug Product Development, Manufacturing, Quality Assurance, and Regulatory Affairs, is required. Prior experience with technology transfer and providing oversight to contract manufacturing organizations and contract testing laboratories is essential. Prior experience with authorship in regulatory filings and regulatory agency interactions is required; experience with BLA/NDA/MAA filings is advantageous. Experience in setting business-appropriate expectations for staff and project teams is required. A proven ability to develop and manage to a budget is a must. Excellent verbal and written communication and teamwork skills are required. Strong project management skills are essential, especially the ability to negotiate proper milestones and track progress against them. Demonstrated ability to develop successful relationships with and influence stakeholders, both internal and external, is essential. The ability to change the thinking or to gain acceptance of others in sensitive situations, using strong negotiation and influencing skills, is essential.

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 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.