BridgeBio
Sr. Scientist/Associate Director, Drug Substance, Development & Manufacturing
BridgeBio, San Francisco, California, United States, 94199
Sr. Scientist/Associate Director, Drug Substance, Development & Manufacturing
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Sr. Scientist/Associate Director, Drug Substance, Development & Manufacturing
role at
BridgeBio . Base pay range $160,000.00/yr - $200,000.00/yr 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 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 Where You'll Work
This hybrid role requires in-office collaboration 2-3x per week in our San Francisco Office. About BridgeBio
BridgeBio is a biotechnology company focused on developing medicines for genetic diseases with high unmet need.
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Join to apply for the
Sr. Scientist/Associate Director, Drug Substance, Development & Manufacturing
role at
BridgeBio . Base pay range $160,000.00/yr - $200,000.00/yr 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 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 Where You'll Work
This hybrid role requires in-office collaboration 2-3x per week in our San Francisco Office. About BridgeBio
BridgeBio is a biotechnology company focused on developing medicines for genetic diseases with high unmet need.
#J-18808-Ljbffr