Director, Analytical Development

Apply Now

Calcilytix Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical stage biopharmaceutical company focused on addressing disorders of calcium homeostasis at the source. Our product candidate is an orally-administered small molecule that specifically inhibits the calcium sensing receptor, hypothesized to restore normal serum calcium and lower urine calcium.
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 drugsranging 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 aim 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.
To learn more, visit us at https://bridgebio.com

Location:

San Francisco, CA

Responsibilites:

  • Management of contract analytical development activities and timelines
  • Review analytical method transfer documentation and release/ stability data for drug substance and drug product
  • Author, review, and approve analytical technical reports
  • Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings.
  • Participate in the CMC strategic planning

Preferred Qualifications:

  • Ph. D./M.S. in life sciences, ideally Chemistry, Pharmacological Chemistry preferred. B.S. will be considered with additional 5 years industrial experience
  • 10+ years’ experience in analytical development in a pharmaceutical setting; 15+ years non-Ph.D. will be considered
  • Expertise and/or familiarity with the current analytical techniques for pharmaceutical development
  • Knowledge and direct experience with CMC analytical requirements for IND/IMPD and NDA/MAA filing
  • Ability to communicate effectively with vendors and external partners regarding project scope, scientific results, and project updates
  • Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices
  • Knowledge of CMC analytical requirements and author experiences with NDA/MAA filing
  • Strong oral and written communication skills
  • Proven abilities in leadership and personnel management
  • Ability to accommodate as much as 25% travel

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
careers

Director, Analytical Development

Apply Now