Senior Director, Analytical Development/Quality Control

ABOUT THE ROLE

nChroma Bio is seeking a Senior Director, Analytical Development/Quality Control to drive the strategic development and execution of nChroma Bio’s Analytical Development and Quality Control functions to support the evolving gene therapy development programs. Strong analytical method development experience in cell-based assays, biophysical analytics, method qualification and tech transfer skills are required for this role. The individual should have substantial experience overseeing virtual QC activities for early-stage biologics or C&GT companies, and a strong knowledge of ICH guidelines and US/EU regulations related to QC. The candidate’s ability to represent the AD/QC function in Regulatory CMC meetings and drafting the Module 3/IB documents is a must. Candidate should be able to build and manage systems and people and have strong written and verbal communication skills.

RESPONSIBILITIES

· Lead and manage a team of scientists to develop and execute analytical methods and run stability studies, ensuring alignment with project timelines and regulatory requirements.

· Responsible for creating and communicating the overall quality control vision/strategy in support of nChroma’s CMC strategy within the company and driving and promoting a culture of continuous improvements that focus on efficiency.

· Lead nChroma’s GMP QC activities supporting external and internal operations.

· Plan, coordinate, and manage routine testing and associated stability programs at CDMOs and CTLs.

· Work with the technical operations team to ensure the development of robust data management systems to support internal and external process and release data storage, trending, and report storage.

· Primary quality individual for the review and approval of test methods, compendial verifications, qualification, and validation activities (including but not limited to protocols and reports, qualification/validation investigations, and others).

· Responsible for aspects of method monitoring, including creation, implementation, and routine execution over time.

· Maintain the reference standard, critical reagent and stability programs.

· Interface with CDMOs and CTLs related to all analytical aspects including deviations, OOS investigations, and method troubleshooting.

· Author QC related SOPs, CAPAs and Change Controls.

· Work with CMC Regulatory for authoring/coordinating and updating clinical and commercial filings (IND, IMPD, BLA, MAA) and responding to agency questions as needed.

· Train and mentor junior team members.

· Travel may be required.

SKILLS & COMPETENCIES

· Impactful leadership skills and demonstrated ability to build and lead a new team.

· Excellent analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.

· Strong oral and written communication skills with experience presenting scientific research both internally across all levels of the organization and externally to other interested parties.

· Ability to thrive in a fast-paced, innovative, and, at times, uncertain or changing environment while remaining flexible, proactive, and resourceful.

· Passionate, adaptable, and keen on working at prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues, and balancing competing priorities effectively.

· Collaborative and team-oriented mindset with a desire to positively impact a new company’s evolving culture.

QUALIFICATIONS

· Candidates should have a degree in a Chemistry, Biochemistry, or other related field with 10+(BS) years of industry experience in Quality Control and/or Analytical Development. Advanced degrees (MS, PhD, etc.) may reduce the total years of experience required.

· Experience with managing external testing labs and manufacturing partners (CTL’s/CDMO’s) quality control aspects in a GMP environment preferred.

· Experience managing early phase quality, both internal and external, required and experience with late phase quality a plus.

· Experience with biologics in a biotechnology setting is required, and technical experience with protein, RNA, cell and/or gene therapy products would all be helpful.

· Experience with scientific writing, US/EU regulatory expectations and CTD section authorship.