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

Role Summary

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

Qualifications

• 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

Skills

• Industrial-scale chemistry development
• Drug substance chemical development, process validation, and manufacturing
• Synthetic organic chemistry
• Analytical method development and validation
• CMC procedures and regulatory documentation (CTD Module 3)
• Technical transfer and collaboration with CROs/CMOs

Education

• PhD in chemistry or chemical engineering preferred; alternative: BS/MS with substantial relevant experience

Additional Requirements

• Hybrid work model; in-office collaboration 2‚Äì3x per week in San Francisco