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Head, Analytical Methods Development
Location: Hatfield, PA

Reporting to the Head, Pharmaceutical Sciences, the Head, Analytical Methods Development will be a key leader within the organization focusing on building a state-of-the-art analytical team responsible for developing qualifiable analytical methods used for QC release, stability and in-process testing, and analytical characterization of Code Biotherapeutics’ innovative gene delivery technology and product pipeline.  This will include supporting the testing needs of the Process Development and Research and Pre-Clinical manufacturing teams. 

She/he will lead and evolve the functional strategy plan for analytical aspects of the corporate portfolio of products, rapid transition from a research/pre-clinical company to a company with multiple clinical candidates and an eye toward commercialization.  This plan must consider the novel nature of this delivery system and the introduction of this modality into a regulated environment.  This position will ensure analytical methods mature appropriately to meet phase appropriate requirements.  This individual will work closely with Program Management to integrate the analytical strategy plan into the overall Corporate Product Development Plans.

The responsibilities of this role are diverse and rewarding.  The successful candidate will have the opportunity to build a high-performance analytical team, participate in laboratory expansion activities and influence analytical CMC strategy for a growing company with novel technology.  This individual will develop a hiring plan to support delivery to the corporate integrated program plans.  This individual will be a senior leader within the Pharmaceutical Sciences organization and will be responsible for providing leadership and strategic direction to the team and to Code Therapeutic senior leadership.  The individual will interface with partners in Research & Development, Process Development, Research and Pre-Clinical Manufacturing as well as CMC Program Management in all aspects of the method development and product development lifecycle.  

Responsibilities
  • Lead a team of internal and external analytical professionals to develop of new analytical methods as well as optimize existing analytical methods for product characterization, in-process testing, release testing, stability, and characterization of starting materials, drug substance and drug product with an eye toward readying them for use in a Quality Control Laboratory. 

  • Build a team of internal and external analytical professionals execute to the goals of the organization. 

  • Develop a strategic plan for the organization that integrates with the for the development of methodologies for the characterization, release and stability of API and drug product with an eye toward the Regulatory requirements for IND filing and ultimately commercial licensure.

  • Participate as a member of the team tasked with defining the needs for current and future laboratory facilities to support the team’s strategic plan.

  • Responsible for leading and managing the AMD organization including managing performance, developing people, hiring, and fostering Code Biotherapeutic’s culture, vision, and values.

Education and Experience
  • Advanced degree with generally 15+ years’ of leadership experience in the Bio/Pharmaceutical industry with expertise in biological, biochemical, or related sciences. 

  • Expertise in biochemistry with a strong understanding of bio-physical product testing and characterization is required. 

  • Potency assay development a plus. 

  • Direct interaction with Regulatory authorities required. 

  • Experience in leading an organization in the development, optimization, and qualification of assays for biopharmaceutical products. 

  • Broad technical knowledge in bioanalytical and physiochemical techniques required.

  • Experience with molecular biology techniques is strongly desired.

  • Prior experience in leading a team in assay development intended for the testing of product produced for use in human clinical trials or for commercial sale. 

  • Prior experience in managing a Quality Control organization preferred. 

Skills, Abilities and Competencies
  • Flexible and comfortable with a fast-paced and evolving business environment

  • Ability to self-prioritize workload, as well as manage and communicate resource conflicts

  • Adaptable with a high degree of learning agility

  • Comfortable working in a team environment with a results-focused work ethic

  • Integrity and commitment to high ethical standards

  • Ability to work in parallel on multiple projects

  • Excellent communication skills

  • Self -motivated and independent minded

  • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and functions

  • Responsive, can-do attitude

  • Strong attention to detail

We offer a competitive salary and benefit package, including an employer matched 401k. Code Bio  is proud to be an Equal Opportunity Employer.

Interested individuals should send a cover letter and CV to careers@codebiotx.com or: