Associate Director, Biologics Downstream Process Development

Location
San Francisco, CA, United States
Posted
Jun 19, 2019
Ref
3529-399-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar Therapeutics has an exciting opportunity for an Associate Director, Biologics Downstream Process Development to join their Biologics CMC organization.

The Associate Director, Biologics Downstream Process Development is responsible for directing and developing the team responsible for downstream process development and integration into manufacturing for Nektar biologics drug candidates in pre-clinical and clinical development. Knowledge and hands-on experience with pharmaceutical process development, GMP manufacturing, and associated state-of the art technologies required. Experience in microbial and/or mammalian produced biologics and associated product quality considerations desirable. Prior experience with inclusion body isolation and protein refolding highly desirable. Process characterization (DOE) and process validation experience highly desirable. Previous management experience and excellent written and verbal communication skills required. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

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. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Support upstream and downstream process creation, testing, and optimization. Develop tasks and maintain timelines to support development of manufacturing technology processes. Directs project workloads to provide innovative technical solutions to meet project deadlines. Develops tasks and maintain timelines to support development of manufacturing technology processes. Directs project workloads to provide innovative technical solutions to meet project deadlines. Develops, supports and maintains development report writing systems, development reports, documents and data storage. Prepares sections of IND and NDA submissions when required. Ensures budgets, schedules and performance requirements are met. Assesses utilization of resources and identifies when, and where additional resources may be needed. Ensures staff members are appropriately trained and training records are maintained at current required levels. Regularly interacts with senior management. Helps to ensure the effective application of process technologies across partner projects. Directs scientists in preparing and updating project work plans. Facilitates technology transfer between organizations and sites to meet required project goals. Directs and develops team(s) responsible for process development following cGMPs or applicable Quality compliance for pharmaceutical products and/or bulk pharmaceutical raw materials/intermediates. Provides regular performance feedback, development and coaching to direct reports.

A minimum of a Bachelors degree in a scientific or engineering discipline is required. An advanced degree is preferred. Equivalent experience may be accepted. A minimum of 10 years' experience in the pharmaceutical or other related industry is required. A minimum of 8 years previous biotechnology/pharmaceutical industry experience, preferably in a process development FDA regulated environment, is required. Good track record in advancing Biologics drug candidates in clinical development and Regulatory agency (FDA, EMA) interaction required. Prior experience with technology transfer and providing oversight to contract manufacturing organizations (CMO) desirable. Excellent written and verbal communications and team work skills are essential. Must have experience within R&D and/or biologics CMC that includes pilot plant, scale up and commercial manufacturing. Must have experience in technology transfer from development into a pharmaceutical production operation. Strong verbal and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Good compliance and safety practices are a must. Must be experienced in working in a team-focused environment. A proven track record in developing and managing process development organizations is a must. Must have a thorough working knowledge of FDA, ISO and cGMP requirements for areas of responsibilities. Project management experience is a plus. A proven ability to work within a budget and timeline and provide cost savings is required.

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.