AD, Biologics (Bioassay)

Nektar Therapeutics San Francisco , CA 94118

Posted 2 months ago

As part of Nektar's Biologics CMC organization, the Associate Director, Biologics will support Nektar drug candidates in pre-clinical and clinical development. Knowledge and hands-on experience with development, qualification, and validation of cell-based bioassay for potency measurement to support GMP manufacture, product characterization, lot release, and stability testing are required.

Extensive experience in GMP, CMO/CRO management, and interaction with regulatory and quality is required. Prior experience with late stage drug development and regulatory filing is desirable. Management experience, excellent written and verbal communication skills are required. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

The successful candidate will be responsible for:

  • Establish and implement bioassay strategy to support Nektar biologics portfolio.

  • Guide the team to develop mechanism of action relevant bioassay to understand and characterize Nektar's biologics molecules.

  • Lead efforts for in house method qualification testing, and transfer methods to CRO for drug substance and drug product release and stability testing.

  • Direct technical project leaders and scientists in preparing and updating project work plans.

  • Develop tasks and maintain timelines to support development of manufacturing technology processes.

  • Communicate cross-functionally with groups such as research, process development, formulation development, manufacturing, QC group and CRO/CMO to ensure appropriate project support.

  • Write technical reports and CMC section for IND and BLA regulatory filings.

  • Ensure budgets, schedules and performance requirements are met. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.

  • Ensure staff members are appropriately trained and training records are maintained at current required levels.

  • Provides regular performance feedback, development and coaching to direct reports.

  • Assesses utilization of resources and identifies when, and where additional resources may be needed. Serves as an in-house consultant.

  • Regularly interacts with senior management.


A minimum of a bachelor's degree in a biology/biochemistry 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 and EMA regulated environment, is required.

Good track record in advancing Biologics drug candidates in clinical development and Regulatory agency (FDA, EMA) interaction required. A thorough knowledge and experience working in a GMP environment is essential. 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 method development, stage appropriate validation, method transfer to CRO and routine sample testing for lot release and stability evaluation. 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 and cGMP requirements for areas of responsibilities. Project management experience is a plus. A proven ability to work within budget and timeline.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Scientist I Bioassay Development

Fiveprime Therapeutics, Inc.

Posted 7 days ago

VIEW JOBS 4/12/2019 12:00:00 AM 2019-07-11T00:00 Company Description Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology. Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year. Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at Job Description We are currently seeking a highly motivated individual to join our Analytical Development group. This position will be responsible for assay development, characterization and qualification of potency assays including both binding assays and cell-based bioassays for early-stage and late-stage clinical programs. In addition, this scientist will perform impurity assays including residual host cell proteins, DNA and protein A to support process development efforts. This scientist will act as a technical resource for supporting process development, formulation development and product characterization. This scientist will also collaborate with the Research Group and evaluate the transfer of bioassays from the Research Group to the Analytical Development Group and further develop/optimize the assays as necessary. Further, this scientist will leverage their expertise to implement new technologies that can accelerate program timelines. The position will report to the Senior Scientist, Bioassay Development. Responsibilities include but are not limited to: * Develop and qualify bioassays following ICH guidelines to implement at CMO/CRO * Draft protocols, execute studies, analyze data and draft technical reports * Provide training to analysts and supervise assay transfer to CMO/CRO * Participate in data review for technical correctness and regulatory compliance * Participate in troubleshooting technical and procedural issues * Comply with all pertinent regulatory agency requirements * Review test methods, SOPs and specifications for biological assays * Design and execute studies to increase the understanding of candidate molecules * Work with cross-functional groups and external contract facilities to meet program timelines * Evaluate new methodologies and test procedures and implement when needed * Author analytical sections for regulatory submissions Qualifications * A PhD degree in biology, cell biology, biochemistry, molecular biology, immunology, or a related discipline with 0-2 years of laboratory experience in industry * Must have hands-on experience in sterile cell culture techniques * Excellent analytical and problem-solving skills * Excellent written and interpersonal communication skills * Highly motivated, flexible, and ability to multi-task * Ability to influence and collaborate in a team environment * Experience in a GLP environment highly desirable Additional Information At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated. FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments. All your information will be kept confidential according to EEO guidelines. Fiveprime Therapeutics, Inc. South San Francisco CA

AD, Biologics (Bioassay)

Nektar Therapeutics