Head of Technical Operations, CMC

Full-TimePhoenixAny Office LocationManufacturing

Apply Now

About Phoenix Tissue Repair & BridgeBio Pharma

Phoenix Tissue Repair, an affiliate of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on advancing a novel systemic treatment for recessive dystrophic epidermolysis bullosa (RDEB) a rare genetic disease affecting the skin and other organs. Our dedicated team of industry veterans is working to develop BBP-589, an investigational protein replacement therapy that uses a recombinant collagen type VII (rC7) to treat RDEB. BBP-589 represents the only potentially disease-modifying treatment in development that may solve the systemic manifestations of RDEB and the more visible skin-related aspects of this devastating disease.

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 phoenixtissuerepair.com | https://bridgebio.com

Who You Are:

The Head of Technical Operations, CMC at Phoenix Tissue Repair is responsible for driving the CMC strategy for our existing biologic drug candidate, BBP-589, an investigational protein replacement therapy that uses a recombinant collagen type VII (rC7) to treat RDEB. This senior level leader will provide oversight to ensure the timely delivery and consistent quality of clinical and commercial global supply.

This drug manufacturing expert will leverage their breadth of experience in process development and expertise in protein purification/protein biochemistry to ensure CMC goals are met and drive the success of the BBP-589 program. Reporting directly into the Executive Chairman, the Head of Technical Operations, CMC will also operate within the broader BridgeBio organization to provide updates around CMC activities and program implications.
Responsibilities:
  • Own all CMC-related activities for Phoenix’s lead late-stage clinical program, BBP-589, also known as recombinant collagen 7 (rC7)
  • Lead operational and strategic activities associated with development and manufacturing of BBP-589 such as process development and characterization, process performance qualification, analytical development and characterization, manufacture, release testing, and stability assessment of BBP-589 drug substance and drug product
  • Drug substance and drug product-related activities, including management of external contract development and manufacturing organizations (CDMOs) necessary to develop and supply clinical trial materials and to establish long term strategies for commercial manufacturing supply objectives
  • Author CMC sections for regulatory submissions and represent CMC during health authority interactions
  • Monitor and forecast CMC budgets

  • 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:
  • Must have strong leadership skills and substantial experience with the development and commercialization of late-stage biotherapeutics
  • A Ph.D. or equivalent in Biochemical Engineering, Biochemistry, or a related field and a minimum of 8 years of experience in a senior management role in process development of biotherapeutics
  • Evidence of depth in protein purification or protein biochemistry development along with breadth of experience in process development and manufacturing is essential
  • Experience with a technical transfer of process from development into cGMP manufacturing setting is essential
  • Experience with process characterization and process performance qualification and all associated activities is required
  • Experience with the preparation of regulatory submissions (CMC section) is also required
  • Evidence of effective direct supervisory skills in process development and contract manufacturing is required, as is cross-functional CMC team and program management skills and experience
  • Effective oral and written communication skills are essential
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.
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Head of Technical Operations, CMC

Full-TimePhoenixAny Office LocationManufacturing

Apply Now