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.

Calcilytix Therapeutics, an affiliate within Bridge Bio 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.

Sr. Scientist/Associate Director, Drug Substance Development and Manufacturing will support Calcilytix Therapeutics, a subsidiary of Bridge Bio 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.

• 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

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

• Minimum of a PhD (ideally chemistry or chemical engineering) with 7+ years relevant experience, or a BS/MS with 10+ years relevant experience
• Demonstrated chemistry development at an industrial scale
• Demonstrated experience in managing drug substance chemical development, process validation, and manufacturing in support of marketing applications and commercial production
• Strong aptitude and demonstrated experience in synthetic organic chemistry
• Working knowledge of analytical method development and validation
• Familiarity with FDA and ICH guidelines for INDs/NDAs/MAAs. Thorough understanding of cGMP, quality, and regulatory requirements for drug substance manufacturing
• Ability to effectively interface with and/or manage highly skilled internal…