[Hiring] Manager/Sr. Manager, QC @BridgeBio Pharma
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Role Description
The Quality Control Manager at Bridge Bio will be an important part of our Quality Control group supporting BridgeBio subsidiaries (Calcilytix, MLBio, and Eidos). The Quality Control Manager is responsible for ensuring that all activities conducted at the analytical Contract Manufacturing Organizations (CMO) laboratories are conducted in compliance with Current Good Manufacturing Practices (cGMP).
• Review of analytical data for release, stability, and in-process testing at the contract manufacturing organizations in a timely manner.
• Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results.
• Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages.
• Submitting test packages to QA for their review and loading all data into the electronic storage program.
• Review of analytical data related to reference standard qualification, method validation and method transfer activities.
• Travel, when necessary, to analytical testing sites or other sites.
Qualifications
• M.S./B.S. in life sciences, ideally Chemistry, Analytical Chemistry preferred.
• 5+ years’ experience in Quality Control in a pharmaceutical setting with solid knowledge of Good Manufacturing Practices (cGMP) and 2+ years management experience.
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines with excellent organizational and planning skills and high attention to detail.
• Sophisticated understanding how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities.
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates.
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.
• 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.
• 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.
Salary
$129,200 — $159,700 USD
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Role Description
The Quality Control Manager at Bridge Bio will be an important part of our Quality Control group supporting BridgeBio subsidiaries (Calcilytix, MLBio, and Eidos). The Quality Control Manager is responsible for ensuring that all activities conducted at the analytical Contract Manufacturing Organizations (CMO) laboratories are conducted in compliance with Current Good Manufacturing Practices (cGMP).
• Review of analytical data for release, stability, and in-process testing at the contract manufacturing organizations in a timely manner.
• Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results.
• Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages.
• Submitting test packages to QA for their review and loading all data into the electronic storage program.
• Review of analytical data related to reference standard qualification, method validation and method transfer activities.
• Travel, when necessary, to analytical testing sites or other sites.
Qualifications
• M.S./B.S. in life sciences, ideally Chemistry, Analytical Chemistry preferred.
• 5+ years’ experience in Quality Control in a pharmaceutical setting with solid knowledge of Good Manufacturing Practices (cGMP) and 2+ years management experience.
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines with excellent organizational and planning skills and high attention to detail.
• Sophisticated understanding how and when to appropriately apply the cGMP requirements; ability to distinguish regulated and non-regulated activities.
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates.
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.
• 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.
• 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.
Salary
$129,200 — $159,700 USD
Apply tot his job
Apply To this Job