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An innovative biotechnology firm is seeking a Senior Director for Analytical Development/Quality Control. This role is pivotal in driving the strategic development of analytical methods and quality control functions that support cutting-edge gene therapy programs. The successful candidate will lead a talented team, ensuring alignment with regulatory requirements while fostering a culture of continuous improvement. If you are passionate about advancing genetic medicine and thrive in a dynamic environment, this opportunity is perfect for you. Join a company at the forefront of biotechnology, where your expertise will help shape the future of targeted therapies and improve patient outcomes.
nChroma Bio is a pioneering biotechnology company redefining the future of in vivo targeted genetic medicine to treat a wide array of diseases and bring cures to patients. The company’s integrated product engine tackles significant limitations of existing genetic medicine approaches by enabling safe, precise and specific in vivo delivery. nChroma’s near clinical-stage development candidate, CRMA-1001, is a liver-targeted therapy in development as a potential functional cure for chronic hepatitis B and hepatitis D that leverages the power of epigenetics, nature's innate mechanism for gene regulation. Guided by a world-class team at the forefront of genetic medicine, founded by renowned pioneers in the field, and supported by top-tier investors, the company is uniquely positioned to deliver groundbreaking therapies with programmable tissue specificity, unlocking highly potent, durable and targeted gene regulation for the liver and beyond.
We’re building a culture and organization to support this important mission, bringing together individuals that thrive in a supportive environment where diverse perspectives and a passion for discovery drive cutting-edge science and breakthrough medicines.
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> 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.
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nChroma Bio is an equal opportunity employer, providing equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, nChroma Bio complies with applicable state and local laws governing nondiscrimination in employment.