Sr. Scientist/Associate Director, Drug Substance, Development & Manufacturing

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 reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.          

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

• 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 staff
• Ability to work independently and 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
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies         

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. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

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