Associate Director, Biologics Formulation

Location
San Francisco, CA, United States
Posted
Jun 09, 2019
Ref
3508-370-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Oversees early to late-stage drug product formulation development within Nektar's biologics portfolio.

Leads drug product development programs responsible for advancing the Nektar proprietary molecule pipeline by establishing strategies and operational plans for pre-formulation evaluation, generation and characterization of clinical stage formulations, development of manufacturing processes and establishing commercial drug product supply chains. Hires and develops staff to lead development and assessment of specific product candidates to advance the understanding therapeutic parenteral drug products. Works closely within Development senior management to create development and registration plans acceptable to global regulatory authorities. Will select, develop, and evaluate personnel to ensure the efficient operation of the function.

Develops drug product pipeline candidates in alignment with corporate and/or organizational policies and authorizes their implementation. Consistently works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas through assessment of intangible variables. Interacts internally and externally with executive-level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Works closely with Research and Clinical Development to (a) create and execute Preclinical and Clinical Development plans , and (b) aid in the advancement of clinical program strategy and directs those systems and programs in order to meet Company goals and objectives. Participates in the development of methods, techniques and evaluation criteria for projects, programs and people. Identifies and develops collaborations with external investigators and opinion leaders. Responsible for working closely with groups such as Toxicology, Clinical Operations, Regulatory Affairs, Clinical Development, Marketing and Business Development. Remains current with scientific developments and publications on similar and competitor products and applies this knowledge to current programs.

A minimum of a Bachelors degree in a Pharmaceutical Sciences, Biochemistry, or Protein Chemistry 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. A minimum of 8 years previous management experience required. Experience in Pegylated protein drug product development including formulation, process development, technology transfer and fill/finish operations. Expertise in early as well as late-stage development of liquid and lyophilized dosage forms for proteins including experience with multiple primary packaging configurations. Knowledge of protein and peptide stabilizing strategies. Understanding of biologics bulk drug substance development aspects pertinent to drug product development and manufacture i.e. formulation, process scale-up, bulk storage etc. Prior supervisory experience and familiarity with cGLP and GMP requirements. Mature communication and inter-personal skills necessary to foster confidence, collaboration and alignment within teams. People/team management skills - Ability to lead and challenge multifunctional teams, facilitate decision-making, work effectively in cross-cultural and cross-company environments. Strong communication (oral and written) communication and organizational skills. Working knowledge of current US, EU, and global Regulations, ICH guidance and relevant standards and quality system requirements for biological product manufacturing. Experienced in planning and executing late stage robustness studies, control strategy, process performance qualification is desirable. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills.Provides guidance for all aspects of biologics formulation/process development. Serves as a subject matter resident expert in biologics formulation development, process optimization, scale-up, process transfer, and GMP manufacturing of liquid and lyophilized drug products. Manages the scientific, strategic, planning and execution aspects of biologics formulation development, primary packaging development, technology transfer, and drug product characterization activities for a variety of biologic molecule types. Authors drug product relevant sections in IND/CTD/BLA/MAA, interact with regulatory agencies, and will be responsible for developing responses to drug product related questions raised during regulatory filings and inspections. As a subject matter expert within drug product development, lead lyophilization development, scale-up, scale-down, and related activities as appropriate for early and late stage biologics projects. Identify, qualify and work with CMOs (Contract Manufacturing Organizations) for sterile clinical supply manufacturing. Other duties as required.

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.