Sr. Manager​/Associate Director, Drug Substance; Hypopara

Mavericks Wanted

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 re‑engineer the future of biopharma. At Bridge Bio, we value curiosity and experimentation‑including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Senior 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 process development and manufacturing activities at contract suppliers, including manufacture of raw materials and drug substance for clinical studies, process validation, commercial launch, and tech transfer to new vendors to build and maintain the commercial supply chain throughout 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 appropriate for performing process validation and commercial supply requirements.
• Lead early to mid‑stage process development and manufacturing to support clinical studies.
• Lead 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 cGMP 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 is a hybrid role and requires in‑office collaboration 2–3 × per week in our San Francisco Office. Fully remote could be considered for the right candidate.

• Minimum of PhD (ideally chemistry or chemical engineering) with 7+ years relevant experience, or BS/MS with 10+ years relevant experience.
• Demonstrated chemical development at 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 staff.
• 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.
• Up to 20% travel may be required.

We have high…