Senior Manager - Quality Assurance

3 days ago

🇺🇸 United States – Remote

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $140k - $160k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

cell therapy • autoimmune • lupus

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Description

• Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. • The Senior Manager will oversee quality for CMO partnerships and investigational product release.

Requirements

• Degree (Bachelors or higher) or equivalent experience in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology • 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years experience in the field of cell therapies preferred. • Expertise with cGMP manufacturing as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPs • Demonstrated ability to manage multiple complex relationships within a CMO network • Experience with electronic Quality Management Systems • Experience in conducting or hosting Quality and/or Health Authority audits. • Excellent interpersonal, verbal and written communication skills • Ability to function efficiently and independently in a changing environment • Ability to operate in a Controlled/Classified Environment, including ability to successfully maintain aseptic technique and complete cleanroom gowning qualification requirements. • Must be willing to travel up to ~50% of time, depending on manufacturing schedule. • Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skills • Strategic thinking and high emotional intelligence • Manage and advance multiple projects simultaneously and dynamically reprioritize as needed • Demonstrated capacity to think creatively when addressing complex situations • Ability to communicate effectively with Kyverna Leadership, clinical, and development scientists, and with external business partners and Regulatory Authorities.

Benefits

• Bonus eligibility • Participation in Company’s stock option plan • Health benefits available • Equal Opportunity Employer