Senior Director, Head of CMC

Full-TimeCalcilytixSan Francisco, CAManufacturing

Apply Now

About Calcilytix & BridgeBio Pharma

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing CLTX-305 (encaleret), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (a genetic cause of hypoparathyroidism due to gain-of-function mutations in CaSR). Encaleret is currently being evaluated in a Phase 2 clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://calcilytix.com/ | https://bridgebio.com

Who You Are:

Calcilytix seeks an experienced, hands-on process chemist to join our rapidly expanding team in the role of Senior Director, Head CMC. This position is directed toward manufacturing and commercializing an existing small molecule drug candidate and reports to Calcilytix’s Chief Scientific Officer. 
Responsibilities:
  • Oversee production activities at CMOs and provide technical support and troubleshooting
  • Author and/or review batch records, change controls, and other technical documents
  • Provide technical expertise that results in sustained manufacturing consistency, robustness, scalability, improved efficiency, and reduced costs
  • Participate in late-stage process development, validation, and preparation of regulatory documents; hands-on NDA filing experience a plus
  • Design, Direct CMOs in Risk Assessments, Multivariate Experiments as necessary
  • Participate in the design of optimization experiments, including multistep syntheses, isolation, and purification of small molecule drugs
  • Contribute to project team meetings with CMOs to ensure manufacturing timelines and forecasts are met
  • Work closely with manufacturing and GMP operations to coordinate project related equipment and activities
  • Provide required support to the Quality/Regulatory functions to establish, implement, maintain, and appropriately document product-related process development, tech transfer, and GMP manufacturing activities
  • Prepare technical reports in support of planned regulatory submissions and future process development work
  • Generate and/or review Process Validation documentation, including Product Validation Master Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols

  • No matter your role at BridgeBio, successful team members are:
  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive towards practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed
Education, Experience & Skills Requirements:
  • Degree (MS or Ph.D.) in chemistry or chemical engineering
  • 10+ years of pharmaceutical small molecule manufacturing/process chemistry experience
  • Strong technical background in small molecule large-scale manufacturing, late-stage process development, and commercialization of APIs
  • Familiarity with state-of-the-art technology development and implementation to improve manufacturing processes and analytical methodologies
  • Fundamental understanding of GMPs, quality, and regulatory requirements
  • Proven ability to manage CMO’s to achieve goals on aggressive timelines
  • Thorough understanding of broad CMC aspects concerning the development, manufacturing, and analysis of small molecule therapeutics
  • Experience with reviewing master batch records, executed batch records, manufacturing deviations, and investigations
  • Excellent working knowledge of process safety, QbD, PAT, and DOE
  • Experienced in the use of systematic investigation techniques to identify causes of process deviations, e.g., root cause analysis
  • Well-versed in the preparation of FMEAs
  • Comfortable using statistical software and techniques to define experimental plans and interpret results (e.g., JUMP, StatEase).  Six Sigma certification is a plus
  • Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential 
  • Strong initiative and desire to work in a fast-paced, team-oriented, dynamic environment
  • Proficiency with Microsoft software (Word / Excel / PowerPoint)
  • Position requires to travel up to 10 - 15% 
What We Offer:
  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn 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
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

Senior Director, Head of CMC

Full-TimeCalcilytixSan Francisco, CAManufacturing

Apply Now