Director, Biologics Formulations

Location
San Francisco, CA, United States
Posted
Sep 06, 2018
Ref
3292-370-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

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

This includes scientific leadership, strategic direction, technical expertise and tactical oversight for tasks/activities in support of biologics drug product development. Provide scientific leadership, strategic direction, technical expertise, and tactical oversight for all activities in the area of biologics formulation development. Provide operational expertise across the organization and be a key contributor to the strategic and functional objectives of the department. Interacts with various inside/outside groups to facilitate programs. May select, develop, and evaluate 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. Responsible to provide guidance for all aspects of biologics formulation/process development. Serves as a functional leader and subject matter resident expert in biologics formulation development, process optimization, scale-up, process transfer, and GMP manufacturing of liquid and lyophilized drug products. Lead 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. Supervises and mentor scientists in developing robust stage appropriate parenteral drug product formulation and manufacturing process by effectively utilizing biopharmaceutical understanding in developing biologics formulation and in-depth understanding of Quality by Design product development, FDA guidance and c-GMP compliance. 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.

A Ph.D degree in a Pharmaceutical Sciences, Biochemistry, or Protein Chemistry is required. Equivalent experience may be accepted. A minimum of 12 + years of industrial experience in drug product development and registration for therapeutic proteins. A minimum of 10 + years previous management experience may be 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.

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.