We are seeking a Director of Quality Control to lead and oversee QC strategy and execution in a fast-paced, research-driven biotech environment while providing support to the Quality Assurance function. This role will serve as the key liaison between JLSa2’s Analytical Development and external CDMOs/testing laboratories to ensure that clinical-stage products are appropriately tested, compliant, and safe for use. The ideal candidate will bring strong technical expertise in biologics - particularly peptide and bioconjugate modalities - and a deep understanding of Quality principles including analytical development, method transfer, and specification setting.

 

Key Responsibilities

  • Partner with QA to implement and enhance the Quality Management System (QMS) in a phase appropriate manner
  • Establish and build QC systems, processes, and infrastructure in a startup environment to support clinical development.
  • Lead QC strategy for clinical-stage programs, ensuring appropriate testing, release, and stability support.
  • Serve as the primary QC interface between internal teams (Analytical Development, CMC) and external CDMOs and testing laboratories.
  • Oversee method lifecycle activities, including development alignment, qualification/validation, transfer, and lifecycle management at external labs.
  • Collaborate with Analytical Development to define and justify specifications, acceptance criteria, and control strategies.
  • Ensure GMP-compliant execution of release and stability testing at CDMOs, including data review, trending, and issue resolution.
  • Partner with QA to support the execution of the QMS (e.g., batch disposition, investigations (OOS/OOT), deviations, and change controls).
  • Provide technical oversight for stability programs, including study design, data interpretation, and shelf-life assessments.
  • Provide quality oversight and approval of investigations associated with laboratory events, including OOS, OOT, atypical results, and analytical deviations.
  • Support regulatory submissions (IND/IMPD) by contributing to Module 3 and responding to health authority questions as needed.
  • Drive continuous improvement of systems, processes, and external partnerships.

 

Technical Expertise

  • Strong knowledge of analytical techniques including HPLC/UPLC, LC-MS, peptide mapping, and bioassays.
  • Experience with characterization and release testing for peptides, large molecules, and bioconjugates.
  • Deep understanding of method development, qualification/validation, and transfer to CDMOs or contract labs.
  • Familiarity with the key principles of the QMS.
  • Expertise in setting specifications, acceptance criteria, and control strategies for clinical-stage products.
  • Familiarity with stability-indicating methods and degradation pathways.
  • Working knowledge of GMP requirements beef up, data integrity, and regulatory expectations for QC testing.

 

Leadership & Operational Skills

  • Proven ability to lead cross-functional initiatives and influence without direct authority in a matrixed environment.
  • Experience building and scaling Quality operations, systems, and external partnerships in a startup or growth-stage company.
  • Strong project management skills, with the ability to manage timelines, priorities, and multiple external vendors simultaneously.
  • Demonstrated ability to drive issue resolution, including investigations (OOS/OOT), root cause analysis, and corrective/preventive actions (CAPA).
  • Excellent communication skills, with the ability to translate complex technical information to cross-functional stakeholders and leadership.
  • Strategic thinker with a hands-on, execution-focused mindset.
  • Ability to operate effectively in a fast-paced, resource-limited environment with evolving priorities.

 

Qualifications

  • Ph.D., M.S., or B.S. in Chemistry, Biochemistry, or related field with 10+ years of relevant experience in QC, Analytical Development, or related functions in biotech/pharma.
  • Strong experience with peptides, large molecules, and/or bioconjugates.
  • Deep understanding of analytical methods (e.g., HPLC/UPLC, LC-MS, bioassays) and method lifecycle management.
  • Demonstrated experience setting specifications and developing control strategies for clinical-stage products.
  • Proven track record of managing method transfers and working effectively with CDMOs and contract testing laboratories.
  • Solid knowledge of GMP requirements, regulatory expectations, and clinical development processes.
  • Experience with stability programs, data trending, and interpretation.
  • Strong cross-functional leadership and communication skills, with the ability to operate effectively in a startup environment.

 

Preferred Attributes

  • Prior experience in early-stage or startup biotech environments.
  • Hands-on experience supporting IND/IMPD filings and health authority interactions.
  • Ability to balance strategic thinking with hands-on execution.