04/12/17

locationPin

Waltham, MA

Associate Director/Director, Analytical Development

We are seeking a highly-motivated, independently-thinking, creative, analytical chemist to join our team as the Associate Director/Director of our analytical group in support of our polymer-drug-conjugate development programs.

The candidate will be responsible for overseeing all activities in our analytical lab and interfacing with our external GLP/GMP contract labs. Your primary role will be to direct the establishment and optimization of methods for characterizing raw materials, API, in-process samples, drug substance, and drug product. This work will require SOP development, method qualification, and specification setting. The responsibilities will also include oversight of our bioanalytical/DMPK group. The candidate will interface closely with the process development and formulation team, as well as with external CROs and CMOs, ensuring quality and consistency throughout the research and development process. This position will be based at XTuit’s facility, which is located at the AstraZeneca Biohub in Waltham, MA.

Key Responsibilities

  • Participate in and foster an interactive, team-oriented culture, interfacing closely with the process development and formulation group and also with the biology and drug discovery teams
  • Provide advice and guidance to senior management for best practice in analytical and bioanalytical strategies and methodologies
  • Direct the analytical and bioanalytical development activities, optimize resources and prioritize efforts to meet key project milestones, and report progress to senior management
  • Manage and prioritize all resources within the analytical department (3 FTEs and 2 co-ops)
  • Independently identify and solve problems and challenges with deliverables, and establish effective solutions to meet key project milestones
  • Develop, motivate, and retain a growing and high-performing analytical team
  • Provide analytical technical support to research, development, and manufacturing operations
  • Oversee the development of analytical methods suitable for internal and external implementation
  • Oversee analytical method technology transfer to contract research and manufacturing organizations (CROs/CMOs)
  • Coordinate and manage analytical activities at multiple CMOs
  • Manage the release of clinical trial materials/components at multiple CMOs
  • Provide direction, guidance, and oversight of stability studies in support of pre-clinical/clinical studies and regulatory filings
  • Prepare relevant chemistry, manufacturing, and controls (CMC) documents pertinent to analytical development and quality control for regulatory submissions

Requirements

  • PhD in chemistry, pharmaceutical sciences, or related discipline, and a minimum of 10 years’ experience in the pharmaceutical/biotech industry
  • Experience developing analytical methods and analyzing and interpreting data (ideally HPLC/MS, NMR, DLS, KF, GPC, and DSC)
  • Experience and knowledge of bioanalytical techniques for analyzing drug levels in blood, plasma, and tissues
  • Understanding of appropriate analytical techniques and specifications required to release raw materials, API, and parenteral drug product formulations
  • Experience with one or more of the following: polymers, polymer-drug-conjugates, and sterile pharmaceutical suspensions
  • Experience with GxPs, USP, and ICH guidelines, as well as industry-best practices
  • Understanding of analytical method qualification and validation requirements throughout the phased pharmaceutical development process
  • Excellent written and verbal communication skills
  • Desire to work in a fast-paced, high-energy, start-up environment

 

Company Information:

XTuit Pharmaceuticals, Inc. is a biopharmaceutical company developing novel microenvironment-activated therapeutics targeting key disease mechanisms that are responsible for hypoxia, decreased drug uptake, drug resistance, and decreased immune response. The Company’s proprietary drug development pipeline and integrated, sophisticated clinical biomarker platform will be used for accelerated clinical development across selected cancers and fibrotic disorders. XTuit’s compounds act through pleiotropic mechanisms to inhibit extracellular matrix synthesis and stabilization, and to silence activated stromal cells, including cancer-associated fibroblasts and stellate cells. As a result, XTuit compounds alleviate hypoxia and enable enhanced drug uptake through solid stress reduction. Moreover, the drugs have been shown to down-regulate stroma-induced tumor and inflammation signaling pathways to overcome treatment resistance. The Company’s founders include Rakesh K. Jain, Ph.D., Andrew Werk Cook Professor of Tumor Biology (Radiation Oncology) at Harvard Medical School and Director, Edwin L. Steele Laboratory for Tumor Biology at the Massachusetts General Hospital; Robert Langer, Sc.D., David H. Koch Institute Professor at the Massachusetts Institute of Technology; Ronald Evans, Ph.D., March of Dimes Chair in Molecular and Developmental Biology and Professor and Director of the Gene Expression Laboratory at the Salk Institute as well as Howard Hughes Medical Institute Investigator; and Alan Crane of Polaris Partners. XTuit is backed by leading investors, including Polaris Partners, New Enterprise Associates, CTI Life Sciences, Arcus Ventures, and Omega Funds.

 

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.

 

Contact Information:

info@xtuit.com; 617-588-3770

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Job - Associate Director/Director, Analytical Development

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