Sr. Scientist / Associate Director, Drug Substance, Development & Manufacturing San Francisco, CA[...]

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on. In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries and empower people to solve problems. If you’re someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we’ll ask “why not?” and help reengineer the future of biopharma.

Affiliate Overview

Calcilytix Therapeutics, an affiliate within BridgeBio Pharma, is developing encaleret, 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 Designation from the US FDA, EMA, and PMDA as well as Fast Track Designation from the US FDA. Results from the Phase 2b clinical study of encaleret in patients in ADH1 were published in the New England Journal of Medicine.

What You’ll Do

Sr. Scientist / Associate Director, Drug Substance Development and Manufacturing will support Calcilytix Therapeutics, a subsidiary of BridgeBio Pharma. This position will be responsible for managing outsourced drug substance manufacturing activities at contract suppliers, including process validation, manufacture of raw materials and drug substance for commercial launch, and tech transfer to new vendors to build and maintain the commercial supply chain throughout the product lifecycle. The position will also support submission of global marketing authorization applications and responses to health agency queries.

Responsibilities

• Manage multiple CMOs and CROs to deliver bulk starting materials, intermediates, and drug substance of sufficient quality and quantity to meet corporate and regulatory requirements. Maintain in-depth knowledge of chemical steps, manufacturing processes, and quality controls
• Establish and maintain business relationships with CROs and CMOs that are appropriate for performing process validation and commercial supply requirements
• Lead late-stage drug substance process finalization, validation, and commercial-scale manufacturing
• Identify and lead key process problem resolution activities and process improvement initiatives
• Work closely with Quality Assurance function to develop and operate appropriate CMC procedures, and to ensure product meets established quality standards
• Create and disseminate technical transfer information required by CROs and CMOs to develop and scale up chemical processes and develop and validate analytical methods
• Support authorship, review, and response to queries on all Module 3 drug substance development sections of CTD. Contribute to the overall regulatory control strategy
• Support a culture of continuous improvement and high-performance teamwork

Where You’ll Work

This hybrid role requires in-office collaboration 2-3x per week in our San Francisco Office.

Who You Are

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

Skill Development & Career Paths :

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

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