Senior Director, Head of CMC

Full-TimeCalcilytixSan Francisco, CAManufacturing

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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 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.

To learn more, visit us at 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
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 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.
careers

Senior Director, Head of CMC

Full-TimeCalcilytixSan Francisco, CAManufacturing

Apply Now