Dynavax Technologies

Associate Director - Director, Analytical Development

US-CA-Berkeley
1 week ago
ID
17-040N
Category
Global Technical Operations

Overview

As a member of the Analytical Technologies team, this role provides technical leadership and managerial guidance to analytical staff for the development of analytical methods for testing and characterization of oligonucleotides, peptides and proteins used in cancer immunotherapy and vaccine products. The role will support analytical development activities for DVAX drug candidates from early drug development programs to commercial products. The successful candidate will monitor industry practices and regulatory standards and implement state of the art method development and validation approaches.

 

This position will work with cross-functional teams to define project needs, deliverables and milestones to meet regulatory requirements, and assure business goals are met. 

Responsibilities

  • Lead activities for analytical characterization of oligonucleotide, peptide and protein drug candidates.
  •  Direct development, optimization, and validation of test methods for assigned projects.
  •  Monitor industry practice for method development and implement new concepts at the department level.
  •  Author, review and approve technical documents including analytical method development reports, method validation protocols and reports, standard operating procedures in compliance with regulatory requirements.
  •  Manage the activities of external research laboratories that have been contracted to conduct assay development and/or sample testing.
  •  Interact internally and externally with management personnel to influence and/or negotiate technical decision-making.
  •  Provide support and analytical development expertise to Regulatory Affairs for submissions and annual reports.
  • Ensure functional resources are aligned to meet the business needs including hiring, training and development of staff to make certain technical capabilities stay abreast of the latest technologies.
  •  Optimize staff productivity and value to the organization by effective coaching and deployment based on skills, knowledge and capabilities.
  •  Support an organization in maintaining a work environment focused on quality that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  •  Other duties as assigned.

Qualifications

  • For the Associate Director level, PhD in relevant scientific field with a minimum of 8+ years’ of industry experience in analytical development of biologics and 3 plus years’ management and leadership experience in directing scientist level staff.   Ideally, the Director will have been at least an associate director for 2+ years.
  • Proven ability to translate business objectives into effective technical and operational plans and successful implementation of such plans.
  •  Drug development experience from IND enabling stage to product commercialization is preferred.
  •  In depth knowledge of cGMPs and other regulatory requirements pertaining to biotechnology and pharmaceutical industries is required.
  •  Must have expert knowledge of product characterization techniques for oligonucleotide, peptides and/or proteins and in depth experience with a wide range of analytical techniques including HPLC, HPLC-MS, spectrophotometric assays, SDS-PAGE, ELISA and Light Scattering.
  •  Must have strong understanding of statistical data analysis.
  •  Excellent analytical, technical writing, communication and data management skills are required.
  •  Proven leadership ability and problem-solving skills are a must.
  • Personal attributes required include:
    • Flexibility and integrity,
    • Goal oriented and self-starter,
    • Practical approach to problem solving,
    • Demonstrated good judgment and decision-making experience,
    • Collaborative and team oriented.

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