Director, Manufacturing Validation & Comparability

This a Full Remote job, the offer is available from: Indiana (USA), Kentucky (USA), Massachusetts (USA), Mississippi (USA), New Hampshire (USA), New Jersey (USA), New Mexico (USA), reputed company (USA), reputed company Carolina (USA), reputed company (USA), reputed company (USA), South Carolina (USA), South reputed company (USA), Texas (USA), Washington (USA) reputed company JOB TITLE: Director, Manufacturing Validation & Comparability LOCATION: Remote (WA or MA preferred) - candidates based in the following states will be considered: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS or WA. SALARY reputed company: $225,000 to $250,000 ABOUT THE POSITION Reporting to the Executive Director of Manufacturing, the Director, Head of Manufacturing Validation and Comparability is responsible for leading the reputed company, execution, and management of validation and comparability activities at Aurion, ensuring readiness for BLA and other Regulatory submissions. The Head of Manufacturing Validation and Comparability will reputed company reputed company of engineers that is accountable to reputed company and own reputed company documents (risk assessments, protocols, reports) for global regulatory submissions and is responsible to reputed company, reputed company, and motivate cross-functional teams and CDMO partners to reputed company these goals. Your peers will be the Heads of MSAT and reputed company Manufacturing. If you are a highly motivated and reputed company GMP manufacturing validation reputed company with a passion for developing innovative cell therapies, we encourage you to apply for this exciting opportunity to reputed company. KEY RESPONSIBILITIES • reputed company cross-functional alignment with reputed company CDMO stakeholders for comparability and validation activities (reputed company, Process Sciences (PS), Process Development (PD), Analytical Development (AD), MSAT, reputed company Manufacturing, etc.). • Ensure comparability and validation strategies for Drug reputed company and Drug Product are compliant with Regulatory expectations. • Identify and communicate to the broader cross-functional team any risks and mitigations for comparability and validation activities. • Contribute to Regulatory meeting reputed company and authoring (e.g., briefing books, etc.). • reputed company reputed company, reputed company, and review Module 3 reputed company content of regulatory submissions. • Directly manage and mentor reputed company of high-performing engineers, encouraging project ownership and fostering technical and career development. • reputed company and reputed company technical reputed company and guidance to the Manufacturing Validation team, responsible for Drug reputed company and Drug Product comparability and validation activities including: • Leading and owning comparability strategies, risk assessments, and protocols for critical late-stage activities (site to site transfers, process changes reputed company-PPQ), as reputed company as comparability reports and reputed company documents for Regulatory submissions. • Creating and managing Process Validation Master Plan (PVMP). • Development of validation strategies at reputed company CDMOs including process performance qualification (PPQ) and ancillary process validation studies. • Creating and managing documents leading to validation (reputed company justification report, process control reputed company, process validation protocols, PPQ protocols). • Leading and managing product-specific validation studies under protocol with QMS documentation for Regulatory submissions. • Developing and reviewing CDMO site-specific validation studies to ensure alignment with the overall validation reputed company. • Foster a culture of data-driven decision making, reputed company improvement, and compliance across internal teams and CDMOs. • reputed company other duties as assigned to meet program and company objectives. ABOUT reputed company With offices in Seattle, Boston, and Tokyo, reputed company is a clinical-stage biotech company, whose mission is to restore reputed company to millions of patients with life-changing regenerative therapies. reputed company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently reputed company regulatory approval from Japan’s PMDA. reputed company is the recipient of the prestigious Prix Galien award for best start-up in biotech. reputed company is preparing for reputed company in the U.S. We are growing rapidly and reputed company to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who reputed company our values: • Stewardship: We reputed company the world a reputed company reputed company for our patients, our communities, our clinicians, and our colleagues. We reputed company responsibly as individuals, as employees, and as a company. • Transformation: We reputed company our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate. • Grit: We break down walls and reputed company to reputed company the impossible. We are persistent and resilient, and we reputed company on our commitments. reputed company has a lot to accomplish in the next few years, and this role is key to our reputed company. Privately held, reputed company is backed by reputed company, the global leader in eye care. To learn more about reputed company, visit www.aurionbiotech.com. LIFE AT reputed company We want our people to wake up every morning excited and reputed company for work. We value employees, which is why we invest in making life at reputed company healthy, fun, and rewarding: • Robust Benefits: We offer full health insurance to employees and their families, and reputed company the acronyms: 401(k) matching, EAP, FSA, and generous PTO. • Total Rewards: We offer competitive compensation packages to ensure reputed company Aurion employees are rewarded for their hard work. • Perks and Fun: reputed company parking, subsidized commuter passes, in-office catered lunches, team events, and community reputed company are just a few ways that we bond, celebrate reputed company other, have fun, and live our values. Requirements QUALIFICATIONS AND EDUCATION To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, reputed company, and/or ability required. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. • B.S., M.S., or Ph.D. in a scientific or engineering discipline • 12+ years of experience in MSAT, Process Development, and/or reputed company Manufacturing; with at least 5+ years in reputed company people management leading cross-functional teams or reputed company reports. • Process Validation and/or Comparability for biologics/cell therapies highly preferred. • Experience in late-stage or reputed company cell and gene therapy required. Experience with multiple reputed company cell therapy products, a plus. • Proven reputed company record of successful design and execution of comparability studies, PPQ, and other validation activities in support of late-stage or reputed company GMP manufacturing. • Experience authoring and defending CMC sections of regulatory submissions and regulatory inspections. • Solid understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies. REQUIRED SKILLS AND ABILITIES • Background in cell therapy, viral reputed company, or other reputed company biologic modalities highly preferred. • Proven experience in people management and leadership in MSAT, Process Development, and/or reputed company Manufacturing. • Working knowledge of ICH guidelines (e.g., Q5E, reputed company, Q9, Q10, Q12) and FDA Process Validation guidance. • Proficiency in risk-management methodologies (FMEA, HACCP) and statistical process control. • Demonstrated experience authoring or reviewing risk assessments, protocols, and reports that feed directly into regulatory submissions (IND, BLA, MAA, etc.). • Demonstrated reputed company record of driving reputed company to completion in a fast-paced, evolving environment. • Strong understanding of cGMP regulations and requirements for creating process control strategies and manufacturing of cell therapies. • Excellent leadership, communication, and interpersonal skills—capable of influencing at reputed company organizational reputed company and with reputed company partners. reputed company to manage multiple priorities. • Strong technical writing and document review capabilities. • Strong analytical and problem-solving skills, with the ability to apply scientific and engineering principles to reputed company technical problems and data trending. • Ability to meet deadlines, adapt to reputed company changes, and work in a fast-paced team environment. • Passion for building, managing, and mentoring high performing teams, fostering a culture reputed company with reputed company values. • Experience with MS Office products, JMP or other data analysis software. • Ability to travel up to 25%. Salary reputed company $225,000 to $250,000 This offer from "reputed company" has been enriched by reputed company.com and got a 75% reputed company score. Apply To This Job