Sr. Director, Formulation Research & Development

Location
San Francisco, CA, United States
Posted
Sep 07, 2019
Ref
3506-370-2019
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

Oversees all early to late-stage drug product formulation/process development within Nektar proprietary molecule pipeline.

The Sr. Director, Formulation Research & Development, will establish 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. This includes scientific leadership, strategic direction, technical expertise and tactical oversight for tasks/activities in support of drug product development. Provides operational expertise across the organization and be a key contributor to the strategic and functional objectives of the department. Interacts with various groups, internal and external, to facilitate programs. Position coordinates drug product activities for all Nektar sites and contactors. 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.

Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues, providing strategy and direction for major functional areas. Requires in-depth knowledge of the functional area, business strategies, and the company's goals. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Develops drug product pipeline candidates in alignment with corporate and/or organizational policies and authorizes their implementation. 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. Ensures budgets and schedules meet corporate requirements. Makes final decisions on administrative or operational matters and ensures operations effective achievement of objectives. Provides guidance for all aspects of drug product formulation/process development. Serves as a functional leader and subject matter resident expert in drug product formulation development, process optimization, scale-up, process transfer, and GMP manufacturing of drug products. Leads the scientific, strategic, planning and execution aspects of drug product formulation development, primary packaging development, technology transfer, and drug product characterization activities for a variety of molecule types. Supervises and mentors scientists in developing robust stage appropriate drug product formulation and manufacturing process by effectively utilizing biopharmaceutical understanding in developing drug product 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/NDA, interacts with regulatory agencies, and is responsible for developing responses to drug product related questions raised during regulatory filings and inspections. As a subject matter expert within drug product development, leads lyophilization development, scale-up, scale-down, and related activities as appropriate for early and late stage projects. Identifies, qualifies and works with CMOs (Contract Manufacturing Organizations) for clinical supply manufacturing. Other duties as assigned.

A Ph.D. degree in a Pharmaceutical Sciences, Biochemistry, or Protein Chemistry or equivalent experience is required. Equivalent experience may be accepted. A minimum of 15 years of industrial experience in drug product development and registration for therapeutic proteins. A minimum of 12 years previous management experience may be required. Experience in PEGylated 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 including experience with multiple primary packaging configurations. Knowledge of protein, peptide, and small molecule stabilizing strategies. Understanding of 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 drug 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.