BridgeBio
Sr. Manager/Associate Director, Drug Product
BridgeBio, San Francisco, California, United States, 94199
Sr. Manager/Associate Director, Drug Product
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding. Overview 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. We\'ll ask "why not?" and help reengineer the future of biopharma.
Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
What You\'ll Do You will be responsible for the oversight of commercial drug product manufacturing at contract manufacturing organizations while facilitating global commercial drug product disposition. You will also work with colleagues in CMC, Supply Chain Operations, Quality Assurance, and CMC-regulatory Affairs, while serving as an important point of technical contact between Eidos and contract manufacturing organizations.
Responsibilities
Person-in-plant oversight of the commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms)
Perform activities related to batch review & release
Participate & provide input to root-cause analysis and CAPA plans
Participate in process confirmations, change controls, & quality oversight
Coordinate investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results
Perform trend analysis of testing and process data for commercial drug products and participate in continuous improvement projects
Generate batch genealogy for commercial materials
Where You\'ll Work This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.
Who You Are
BA/BS degree in Life Sciences, Engineering, or related field required
Minimum of eight (8) years of experience within the pharmaceutical industry required
Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations.
Experience with cGMP quality oversight and on-floor production support required
An understanding of Quality Management Systems is required
Prior experience as a liaison with solid oral dosage form contract manufacturing organizations is required
Ability to periodically travel within the EU and to the United States (up to 40% at times)
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.
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Referral program with $2,500 award for hired referrals
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
BridgeBio strives to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Salary range for California candidates: $160,000 - $200,000 USD. Final offer depends on experience, education, location, and interview performance.
If you are interested in building your career at BridgeBio Pharma, consider creating a Job Alert and applying to this role.
#J-18808-Ljbffr
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding. Overview 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. We\'ll ask "why not?" and help reengineer the future of biopharma.
Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).
What You\'ll Do You will be responsible for the oversight of commercial drug product manufacturing at contract manufacturing organizations while facilitating global commercial drug product disposition. You will also work with colleagues in CMC, Supply Chain Operations, Quality Assurance, and CMC-regulatory Affairs, while serving as an important point of technical contact between Eidos and contract manufacturing organizations.
Responsibilities
Person-in-plant oversight of the commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms)
Perform activities related to batch review & release
Participate & provide input to root-cause analysis and CAPA plans
Participate in process confirmations, change controls, & quality oversight
Coordinate investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results
Perform trend analysis of testing and process data for commercial drug products and participate in continuous improvement projects
Generate batch genealogy for commercial materials
Where You\'ll Work This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.
Who You Are
BA/BS degree in Life Sciences, Engineering, or related field required
Minimum of eight (8) years of experience within the pharmaceutical industry required
Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations.
Experience with cGMP quality oversight and on-floor production support required
An understanding of Quality Management Systems is required
Prior experience as a liaison with solid oral dosage form contract manufacturing organizations is required
Ability to periodically travel within the EU and to the United States (up to 40% at times)
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.
Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Referral program with $2,500 award for hired referrals
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
BridgeBio strives to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Salary range for California candidates: $160,000 - $200,000 USD. Final offer depends on experience, education, location, and interview performance.
If you are interested in building your career at BridgeBio Pharma, consider creating a Job Alert and applying to this role.
#J-18808-Ljbffr