Eidos Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.
BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.
Who You Are:
The Senior Quality Assurance Specialist will perform and manage quality assurance lot release activities at Eidos’ contract manufacturing organizations (CMOs). This individual will review Batch records and quality data for lot release. This position will serve as the quality reviewer for deviations, change records and CAPAs generated from or pertaining to our CMOs as needed. This individual will interact with CMOs and internal stakeholders to ensure quality review.
- Perform review manufacturing batch records and associated analytical test results from CMOs to align with internal approved documents
- Perform lot release activities and manage communication of lot release schedules to key internal stakeholders
- Perform review of quality events as documented by contract manufacturers and approve quality events as needed
- Communicate deficiencies/non-conformances to management
- Identify gaps and recommend continuous improvement of quality operations and department databases
- Recommend improvement to quality systems, as needed
- Other duties as assigned
Education, Experience & Skills Requirements:
- Bachelor’s degree with 5+ years of relevant Quality experience within a biopharmaceutical company, or contract research organization; direct industry experience in lieu of education will be considered
- Experience in both Clinical and Commercial environment
- Knowledge of ICH, GMP, and Good Documentation Practice principles
- Ability to engage in cross-functional interactions with internal and external staff
- Excellent verbal and written communications skills, with a strong customer focus
- Good organizational skills, ability to manage multiple tasks, and maintain meticulous attention to detail
What We Offer:
- Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
- A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
- Learning and development training to help employees be the best version of themselves
- Collaborative business environment
- Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
- Excellent benefits package
- Flexible PTO
- With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
- A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
- Work with the most productive groups of R&D operators in the industry
- Partnerships with leading institutions
- A platform for meaningful scientific contributions to shine
- Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.