Senior Manager, CMC Analytical Development Remote - USA
BridgeBio Inc., California, MO, United States
Senior Manager, CMC Analytical Development
Remote - USA
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.
Who You Are
The Senior Manager of Analytical Development will join the Analytical Development Team within Chemistry and Manufacturing and Controls (CMC) and report to a Director of Analytical Development. This role will work closely with the entire CMC team to execute late‑stage development activities in support of Phase III clinical trials through commercial activities. Candidates for this position will be required to work independently and have experience managing outsourced analytical activities at contract manufacturing sites and testing labs.
Where You'll Work
This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
Responsibilities
Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP)
Manage analytical documentation (i.e., CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS)
Support and author analytical content for CMC regulatory content for U.S. and Rest of World dossiers
Manage GMP stability studies and provide trend analysis in support of retest and shelf‑life extension
Development and approval of specifications for raw materials, intermediates, and finished product and knowledge of regulatory requirements in the setting of specifications
Development and validation of analytical methods and verification of compendial methods
Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
Provide analytical support for API and drug product process development
Authoring of development reports, protocols, and methods
Support quality audits as a technical representative and contribute to authoring of audit reports
Education, Experience & Skills Requirements
At least 7 years of experience in analytical development in a pharmaceutical setting
Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.)
Independently proficient in a variety of analytical techniques and regulatory areas including, but not limited to HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase appropriate analytical method validation
Knowledge and direct experience with CMC analytical regulatory requirements and authoring of IND/IMPD filings and response to regulatory inquiries; experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy
Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals
The position will require an ability to adapt to changes in priorities on short notice and will also need an ability to make decisions, independently, under tight timelines
Travel up to 20%
At BridgeBio, we strive to provide a market‑competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi‑state employer, and this salary range may not reflect positions based in other states.
$148,800 - $177,400 USD
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For USA based roles:
Market‑leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre‑tax commuter benefits
(transit and parking)
Referral bonus
for hired candidates
Subsidized lunch and parking
on in‑office days
100% employer‑paid medical, dental, and vision premiums
for you
and
your dependents
Health Savings Account (HSA)
with annual employer contributions, plus
Flexible Spending Accounts (FSA)
Fertility & family‑forming benefits
Expanded mental health support
(therapy and coaching resources)
Hybrid work model
with flexibility
Flexible, “take‑what‑you‑need” paid time off
and company‑paid holidays
Comprehensive paid medical and parental leave
to care for yourself and your family
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, & BetterUp Coaching
We celebrate strong performance with financial rewards, peer‑to‑peer recognition, and growth opportunities
U.S. Standard Demographic Questions We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.
How would you describe your gender identity? (mark all that apply)
How would you describe your racial/ethnic background? (mark all that apply)
How would you describe your sexual orientation? (mark all that apply)
Do you identify as transgender? (select one)
Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and learning? (select one)
Are you a veteran or active member of the United States Armed Forces? (select one)
We use Greenhouse’s AI‑powered Talent Matching tool to compare your application against our job requirements.
#J-18808-Ljbffr
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.
Who You Are
The Senior Manager of Analytical Development will join the Analytical Development Team within Chemistry and Manufacturing and Controls (CMC) and report to a Director of Analytical Development. This role will work closely with the entire CMC team to execute late‑stage development activities in support of Phase III clinical trials through commercial activities. Candidates for this position will be required to work independently and have experience managing outsourced analytical activities at contract manufacturing sites and testing labs.
Where You'll Work
This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
Responsibilities
Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP)
Manage analytical documentation (i.e., CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS)
Support and author analytical content for CMC regulatory content for U.S. and Rest of World dossiers
Manage GMP stability studies and provide trend analysis in support of retest and shelf‑life extension
Development and approval of specifications for raw materials, intermediates, and finished product and knowledge of regulatory requirements in the setting of specifications
Development and validation of analytical methods and verification of compendial methods
Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
Provide analytical support for API and drug product process development
Authoring of development reports, protocols, and methods
Support quality audits as a technical representative and contribute to authoring of audit reports
Education, Experience & Skills Requirements
At least 7 years of experience in analytical development in a pharmaceutical setting
Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.)
Independently proficient in a variety of analytical techniques and regulatory areas including, but not limited to HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase appropriate analytical method validation
Knowledge and direct experience with CMC analytical regulatory requirements and authoring of IND/IMPD filings and response to regulatory inquiries; experience applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy
Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals
The position will require an ability to adapt to changes in priorities on short notice and will also need an ability to make decisions, independently, under tight timelines
Travel up to 20%
At BridgeBio, we strive to provide a market‑competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi‑state employer, and this salary range may not reflect positions based in other states.
$148,800 - $177,400 USD
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For USA based roles:
Market‑leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre‑tax commuter benefits
(transit and parking)
Referral bonus
for hired candidates
Subsidized lunch and parking
on in‑office days
100% employer‑paid medical, dental, and vision premiums
for you
and
your dependents
Health Savings Account (HSA)
with annual employer contributions, plus
Flexible Spending Accounts (FSA)
Fertility & family‑forming benefits
Expanded mental health support
(therapy and coaching resources)
Hybrid work model
with flexibility
Flexible, “take‑what‑you‑need” paid time off
and company‑paid holidays
Comprehensive paid medical and parental leave
to care for yourself and your family
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, & BetterUp Coaching
We celebrate strong performance with financial rewards, peer‑to‑peer recognition, and growth opportunities
U.S. Standard Demographic Questions We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.
How would you describe your gender identity? (mark all that apply)
How would you describe your racial/ethnic background? (mark all that apply)
How would you describe your sexual orientation? (mark all that apply)
Do you identify as transgender? (select one)
Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and learning? (select one)
Are you a veteran or active member of the United States Armed Forces? (select one)
We use Greenhouse’s AI‑powered Talent Matching tool to compare your application against our job requirements.
#J-18808-Ljbffr