Sr. Manager / Associate Director, Drug Substance; Hypopara

Senior 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 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.

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  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.

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  Establish and maintain business relationships with CROs and CMOs appropriate for performing process validation and commercial supply requirements.

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  Lead early to mid-stage process development and manufacturing to support clinical studies.

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  Lead validation and commercial-scale manufacturing.

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  Identify and lead key process problem resolution activities and process improvement initiatives.

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  Work closely with Quality Assurance function to develop and operate appropriate cGMP procedures, and to ensure product meets established quality standards.

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  Create and disseminate technical transfer information required by CROs and CMOs to develop and scale up chemical processes and develop and validate analytical methods.

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  Support authorship, review, and response to queries on all Module 3 drug substance development sections of CTD. Contribute to the overall regulatory control strategy.

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  Support a culture of continuous improvement and high-performance teamwork.

This is a hybrid role and requires in-office collaboration 2-3x 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 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