BridgeBio · 6 hours ago
Manager/Sr. Manager, Drug Product (Solid-Oral Dose) Commercial Manufacturing Operations
United States
Full-time
Remote
Mid, Senior Level
$129K/yr - $177K/yr
5+ years expBridgeBio is a pioneering biotech company focused on developing life-changing medicines for patients with unmet needs. The role involves overseeing day-to-day manufacturing activities at contract manufacturing organizations (CMOs) for drug product manufacturing and ensuring the timely delivery of drug product batches while collaborating with various CMC functions.
BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
Responsibilities
Day-to-day activity oversight of commercial DP CMOs for small molecule solid-oral dose manufacturing and release of bulk DP, in collaboration with various CMC functions
Holds teleconferences with CMO and suppliers; takes meeting minutes, tracks action items, creates workflows for complex and interdisciplinary CMC procedure and processes. Ensures delivery of DP batches on time and in full in accordance to supply plans
Leads or supports documentation review and approval (MBRs, specs, methods), change controls and documentation for batch disposition
Oversees investigations related to deviations and complaints, with proper evaluation of impact to product and processes. Manages the close out of the investigations in a timely manner with the proper root cause analysis and establishment of appropriate CAPAs
Identifies and leads key process problem resolution activities and process improvement initiatives, resolves issues. Candidate must have technical (formulation/chemical engineering) background of small molecule tablet manufacturing on commercial, large scale production (process, equipment, analytical etc)
Create and disseminate technical transfer information and documents required by CMOs for feasibility, transfer, validation and routine manufacturing
Partner with CMC/QA/QC/RA CMC functions to develop and operate appropriate CMC procedures, ensure product meets established quality standards, adheres to established approved parameters filed in various regions. Works closely with supply chain group to design production schedules while maximizing production and cost efficiencies
Qualification
Required
BS/MS (Life Sciences, Engineering) with at least 5-7 years relevant experience in commercial bulk DP manufacturing (preferably solid oral dose of small molecule) and analytical activities required in commercial DP manufacturing
CMO management or experience within manufacturing plant (experience in commercial manufacturing; engineering knowledge at industrial scale)
Experience in formulation development, process validation and tech transfer in support of marketing applications
Working knowledge of modern analytical methods pertaining to small molecule DP
Project leadership experience with cross-functional CMC experience
Ability to effectively interface with highly skilled internal staff, ability to build good work relationships while being able to work independently
Familiarity with FDA and ICH guidelines, such as 21CFR210 and 211, and thorough understanding of cGMP, quality and regulatory requirements, including the preparation and writing of key sections of regulatory documents (such as NDAs, MAAs and INDs)
Understanding of supplier performance management (KPI, quality metrics, adherence to supply and quality agreements etc) as well as metric selection, measurement and analysis
Self-motivated individual with strong attention to detail and time management skills with excellent oral and written communication skills
Up to 25% travel may be required; may function as a technical person in plant during production and during tech transfer activities
Benefits
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
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
Company
BridgeBio
BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.
201-500 employees
H1B Sponsorship
BridgeBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$4.9BKey Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2026-01-16Post Ipo Debt· $550M
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
BioWorld Financial Watch
2026-01-17
Company data provided by crunchbase