Sr. Manager/Associate Director, Drug Substance Development - San Francisco, CA, United States - BridgeBio Pharma, Inc.

Description

About Calcilytix & BridgeBio Pharma

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluated in a Phase 3 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, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at |

Who You Are

The Senior Manager/Associate Director, Drug Substance Development and Manufacturing will oversee key 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): the development of chemical processes for active pharmaceutical ingredients (APIs) and regulatory starting materials (RSMs), process scale-up, technology transfer, and validation of chemical processes. Effective management of CROs and CMOs will be a key strategy and activity required to accomplish the functions mentioned. The position will also contribute to overall strategy and authoring of Module 3 drug substance sections of regulatory submissions by provision of required scientific data and document review.

Responsibilities

Proven leadership experience in managing drug substance development teams at various experience levels internally (direct report mgmt.) and externally (CRO/CMO mgmt.)

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

Establish and maintain business relationships with CROs and CMOs appropriate for performing process development requirements

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 process for commercial-scale manufacturing

Extract scientific data and provide appropriate document review to support regulatory filings and commercialization in a timely manner

Create a culture of continuous improvement and high-performance teamwork

Continually seek and implement process development best practice methodologies

Work closely with QA function to develop and operate to appropriate CMC procedures, and to ensure the product meets established quality standards

Support authorship, review, and response to queries on all Module 3 drug substance development sections of 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. Prior NCE filing experience a plus

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 toward 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 drug substance 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 separation techniques pertaining to 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 the preparation and writing of key sections of regulatory documents (such as NDAs, MAAs, and INDs)

Experience in managing CMOs, scientific collaborations, and contracted R&D

Ability to effectively interface with and/or manage highly skilled internal staff

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