Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Target Resume Now
Tailor your resume to this Associate Director / Senior Manager role.
Rezi rewrites your resume against BridgeBio Pharma's job description. Free.
Tailor your resume to this Associate Director / Senior Manager role.
Rezi rewrites your resume against BridgeBio Pharma's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Associate Director / Senior Manager posting at BridgeBio Pharma — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Associate Director / Senior Manager posting at BridgeBio Pharma — free, in seconds.
About the Role
BridgeBio pioneers a "moneyball for biotech" approach, pooling early-stage research to reduce risk and unleash innovation. We build bridges to groundbreaking advancements in rare disease and develop life-changing medicines for patients with unmet needs. We empower people to solve problems and reengineer the future of biopharma, valuing curiosity, experimentation, and the ethical use of AI.
Responsibilities
- Oversight of manufacturing activities as the technical and operational lead for BridgeBio’s Ecaleret program.
- Manage commercial routine manufacturing, technical transfer, process validation, documentation review, and batch disposition.
- Serve as a key technical contact between Calcilytix and CMOs.
- Oversee day-to-day activities of commercial Drug Product (DP) Contract Manufacturing Organizations (CMOs) for small molecule solid-oral dose manufacturing and release.
- Conduct teleconferences with CMOs and suppliers, track action items, and create workflows for CMC procedures.
- Ensure timely delivery of DP batches in accordance with supply plans.
- Lead or support documentation review and approval, change controls, and batch disposition documentation.
- Oversee investigations related to deviations and complaints, evaluating product and process impact.
- Manage the timely close-out of investigations with root cause analysis and CAPAs.
- Identify and lead process problem resolution and improvement initiatives.
- Create and disseminate technical transfer information and documents for CMOs.
- Partner with CMC/QA/QC/RA CMC functions to develop and operate CMC procedures.
- Ensure product meets quality standards and adheres to approved parameters.
- Collaborate with the supply chain group to design production schedules for efficiency.
Requirements
- BS/MS (Life Sciences, Engineering) with at least 5-7 years of relevant experience in commercial bulk DP manufacturing (preferably solid oral dose of small molecule) and analytical activities.
- CMO management or experience within a manufacturing plant (commercial manufacturing; industrial-scale engineering knowledge).
- Experience in formulation development, process validation, and tech transfer for marketing applications.
- Working knowledge of modern analytical methods for small molecule DP.
- Project leadership experience with cross-functional CMC experience.
- Ability to effectively interface with skilled internal staff and build good work relationships while working independently.
- Familiarity with FDA and ICH guidelines (e.g., 21 CFR 210 and 211) and thorough understanding of cGMP, quality, and regulatory requirements.
- Experience in preparing and writing key sections of regulatory documents (NDAs, MAAs, INDs).
- Understanding of supplier performance management (KPIs, quality metrics, supply/quality agreements).
- Self-motivated with strong attention to detail and time management skills.
- Excellent oral and written communication skills.
- Up to 25% travel may be required.
- May function as a technical person in-plant during production and tech transfer activities.
Skills
- Drug product manufacturing
- CMO management
- Technical transfer
- Process validation
- Documentation review
- Batch disposition
- Quality event support
- Formulation
- Chemical engineering
- Small molecule tablet manufacturing
- Process problem resolution
- Process improvement
- Analytical methods
- Project leadership
- Cross-functional CMC
- Regulatory documentation
- Supplier performance management
- Attention to detail
- Time management
- Communication skills
Location
- San Francisco Bay Area (hybrid)
- US-remote (with quarterly visits to San Francisco office)
Work Type
- Hybrid
- Remote
- Full-time
Experience Level
- 5-7 years relevant experience
Education Level
- BS/MS (Life Sciences, Engineering)
Salary/Compensations
- $173,100—$215,000 USD
Benefits
- Market-leading compensation
- Annual performance bonus
- Company equity
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits
- Referral bonus
- Subsidized lunch and parking on in-office days
- 100% employer-paid medical, dental, and vision premiums for employee and dependents
- Health Savings Account (HSA) with annual employer contributions
- Flexible Spending Accounts (FSA)
- Fertility & family-forming benefits
- Expanded mental health support
- Flexible, take-what-you-need paid time off
- Company-paid holidays
- Comprehensive paid medical and parental leave
- Career pathing
- Continuous education
- Professional development programs (LinkedIn Learning, LifeLabs, BetterUp Coaching)
- Financial rewards for strong performance
- Peer-to-peer recognition
About the Company
- Founded in 2015, BridgeBio pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia under one financial umbrella to reduce risk and unleash innovation.
- The company builds bridges to groundbreaking advancements in rare disease and develops life-changing medicines for patients with unmet needs.
- BridgeBio empowers people to solve problems and reengineer the future of biopharma.
- The company values curiosity and experimentation, including the ethical and thoughtful use of AI.