Associate Director, Analytical Sciences

About Ikena
Ikena Oncology (NASDAQ: IKNA) is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies and has a global strategic collaboration with Bristol Myers Squibb.

Role Description
Ikena is searching for a versatile, quality minded Senior Scientist, Analytical Sciences. The incumbent will oversee the analytical activities for drug substance and drug product for our small-molecule programs. They will responsible for method development and qualification and stability programs through the lifecycle on our pipeline programs. The individual will be expected to contribute to both early and late-stage development activities and provide support for regulatory submissions/content. This position reports to the Vice President, Head of Technical Operations and is based in our Boston, MA location.

Responsibilities

  • Oversee analytical activities to support our small molecule clinical stage programs at external partner sites, for both drug substance and drug products
  • Develop and manage phase appropriate qualification and validation strategies for QC methods
  • Provide scientific direction to partner sites on the analytical development of method, review and approve protocols and reports
  • Manage stability programs for all critical material and establish expiry/retest dating and/or shelf life
  • Review procedures/protocols/ to ensure compliance with industry guidelines and standard
  • Author and maintain documentation in support of regulatory submissions
  • Contribute to the establishment of specifications as required
  • Provide scientific guidance to other functional areas regarding analytical methodologies as needed
  • Perform all activities with quality minded approach, and through sound scientific methodologies
  • Assist in managing and building a network of outsourced partners as projects require


Qualifications

  • Ph.D Degree in chemistry, analytical chemistry, life sciences or related field and at least 8+ years’ experience, or Master’s or bachelor’s degree with at least 8+ years of extensive relevant work experience in pharmaceutical industry, including significant direct experience with method development and qualification
  • In-depth knowledge of analytical methodologies, method development and qualification
  • Extensive experience working with small molecule drug substance and drug product release methods required, understanding of solid state and characterization of small molecules preferred
  • Working knowledge of USP, FDA, EMA & ICH guidelines, GXP’s and industry practices
  • Proven track record of successfully overseeing analytical development and qualification activities and managing outsourced activities at CMO’s/CRO’s
  • Experience working with process and formulation development, manufacturing, quality assurance and control teams
  • Experience with contributing to CMC sections of clinical trial and marketing applications worldwide
  • Comfortable in a fast-paced environment and able to adjust based upon changing priorities
  • Must be team oriented, goal-driven, organized, and highly collaborative
  • Excellent communication skills, verbal and written to facilitate collaboration internally and externally
  • Must be able to travel, domestically and internationally, as required, and when safe to do so, to support our external relationships and operations

Personal attributes: team oriented, goal-driven, organized, highly collaborative, open-minded, data-driven, creative, persistent in the face of obstacles and uncertainty, flexible, self-aware of strengths and weaknesses, objective in the evaluation of data and strongly optimistic about overcoming challenges.

Application Form

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