Associate Director/Director, Drug Substance Development & Manufacturing

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

The Associate Director/Director, Drug Substance Development & Manufacturing will oversee critical scientific, regulatory, and business functions pertaining to process chemistry for the organization. Responsibilities include oversight of late development/launch preparation activities, including (but not limited to): contributing to the overall strategy and authoring of Module 3 drug substance sections of Calcilytix regulatory submissions by the provision of required scientific data and document review, development of chemical processes for active pharmaceutical ingredients (APIs), process scale-up, technology transfer, and validation of chemical processes. Effective management of CROs and CMOs will be a crucial strategy and activity required to accomplish the functions mentioned.

Responsibilities

• Proven leadership experience in managing drug substance development teams at various experience levels internally (direct report mgmt.) and externally (CRO/CMO mgmt.)
• Writing, reviewing, and responding to queries on all Module 3 drug substance development sections of Calcilytix CTD. Expected to contribute to the overall regulatory strategy for the encaleret program (responsible for DS and consulted for DP strategy)
• Preference will be given to candidates with prior NDA/MAA authoring experience; previous NCE filing experience a plus
• Manage multiple CMOs/CROs to deliver final bulk active drug substance (incl. intermediates) of sufficient quality and quantity to meet corporate and regulatory requirements
• Create and disseminate technical transfer information and documents required by CROs/CMOs to develop and scale up chemical processes and develop analytical methods for APIs
• Establish and maintain business relationships with CROs and CMOs appropriate for performing the process development requirements for Company API candidates
• Compose key terms for/review/execute contracts with, and manage the activities of CROs/CMOs required to deliver process development tasks on time and within established budgets
• Maintain in-depth knowledge of chemical steps, manufacturing processes, and quality controls
• Ensure that CRO/CMO activities and other process development activities address drug substance needs for pharmaceutical formulation development, toxicology testing, clinical trials, and commercial launch
• Ensure that all chemical processes are developed to deliver on company targets of cost, quality, safety, environmental, and operability needs
• Maintain a working knowledge of manufacturers and suppliers of chemical raw materials, reagents, and intermediates capable of addressing the process requirements of the company in a timely and economical manner
• Identify and lead key process problem resolution activities and process improvement initiatives
• Lead scale-up, process development, process engineering, and finalization (validation) of the process for commercial-scale manufacturing
• Extract scientific data and provide appropriate document review to support regulatory filings and commercialization promptly
• Lead and develop a process development team as appropriate
• Create a culture of continuous improvement and high-performance teamwork
• Continually seek and implement process development best-practice methodologies
• Work closely with Company QA unit to develop and operate to proper CMC procedures and to ensure the product meets established quality standards
• Up to 20% travel may be required
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

• Minimum of Ph.D. (ideally chemistry, chemical engineering) with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
• Demonstrated experience in managing API chemical development, process validation, and manufacturing in support of NDA marketing applications and commercial production
• Demonstrated track record of delivering candidate(s) into chemical manufacturing and commercialization
• Demonstrated chemistry development at an industrial scale
• Significant project leadership experience
• Strong aptitude and demonstrated experience in synthetic organic chemistry
• Working knowledge of modern analytical separations techniques on the separation/purification of organic compounds
• Working knowledge of analytical methods development and validation
• Familiarity with FDA and ICH guidelines for INDs/NDAs/MAAs and cGMPs
• This position will also require a thorough understanding of cGMP, quality, and regulatory requirements, including preparing and writing critical sections of regulatory documents (such as NDAs, MAAs, and INDs); this individual should possess combined with exceptional project leadership, organization, and communication skills.
• Experience in managing CMOs, scientific collaborations, and contracted R&D
• Ability to effectively manage highly skilled internal staff (direct reports)
• Training and education in organic synthesis
• Working knowledge of process economics
• Ability to work independently as well as in a team; ability to build good work relationships
• Strong attention to detail and time management skills
• Excellent oral and written communication skills

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

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