Scientist, Analytical Development (Seattle)

Full Time
Seattle, WA
Posted
Job description
Overview:

Who we are.
Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells.


If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.


What we do.
  • Vision – Pioneering the future of immunotherapy.
  • Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.


How we do it.

The Dendreon Way. We are a purpose-driven, value-based culture. At Dendreon, we…

  • Put Patients First: Every day is a new opportunity to improve the lives of patients living with cancer.
  • Act with Integrity: Be honest, transparent, and committed to doing what’s right in every situation.
  • Build Trust: Building trust takes time. Engage teammates, be candid and transparent.
  • Raise the Bar: Harness continuous improvement, foster innovation and elevate our people.
  • Drive Results: Be accountable and execute – we win when everyone performs.

Primed for Growth - Contract/Partner Manufacturing Business Unit.

Dendreon has been working in the cellular immunotherapy space for over 10 years and brings all the experiences that comes with developing a complex manufacturing process from clinical development through to consistent commercial production. Dendreon is unmatched in its patient logistics/operational functions, manufacturing excellence in cellular therapies and commercial sales team for cellular immunotherapies. Given this expertise, we plan to leverage these strengths to grow Dendreon's pipeline of products initially through contract manufacturing for partners and then patient operations and eventually commercial sales.


Are you ready?

Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and

looking for a unique career opportunity, view our open positions to apply or refer a friend today.


Job Summary:

Scientist/Sr. Scientist will be part of the Research and Manufacturing Sciences, Analytical Sciences department. Responsible for applying expertise in one or more technical areas of method development, optimization, method validation and technical transfer. Also acts as an analytical subject matter expert.
Responsibilities:
  • Lead efforts to optimize existing bioassay (including but not limited to bead-, cell-, and flow cytometry-based assays) methods.
  • Responsible for developing, transferring, and validating bioassay and flow methods.
  • Provided analytical technical support to a Quality Control troubleshooting and investigating test methods.
  • Write, review, and approve method validation and tech transfer protocols and reports.
  • Review and approve protocols, procedures, and reports.
  • Act as subject matter expert (SME) on bioassay methods during non-conformance investigations and regulatory inspections.
  • Lead cross-functional project teams, when required.
  • Maintain study records and document results in technical reports.
  • Write, revise, review or approve operating procedures and test methods, as appropriate.
  • Complete appropriate GMP training, when needed.
  • Document investigations in reports and memoranda, as appropriate.
  • Provide support for regulatory submissions.

Scope:
  • Uses professional concepts, company policies and procedures to solve a variety of problems.
  • Supervises scientific staff.
  • Works on problems of complex scope.
  • Introduces applicable principles to the department and orients them on appropriate usage.
  • Establishes new principles with usage guidelines and training as appropriate.
  • Works with minimal supervision.

Qualifications:
  • 0-7 years of successful postdoctoral or industry experience, or a BS/MS with extensive industry experience in bioassay methods (title will be commensurate with experience)
  • Experience supervising scientific staff preferred.
  • Experience with flow cytometry, cellular- and bead-based bioassays, tissue culture, and aseptic technique.
  • Experience validating and transferring methods and working in a regulated environment under cGMP are required.
  • Working knowledge of cGMP requirements.
  • Ability to solve problems through analysis.
  • Excellent written and verbal communication skills.
  • Strong organizational skills required.
  • Proficient in MS Office applications.

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