Commercial Manufacturing Ops Lead, CMO Partnerships

BridgeBio Pharma; Owens (OH); Hybrid; USD 173,000 - 215,000; Full time

Benefits offered by this job

Hybrid work model

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Referral bonus

Job summary

BridgeBio Pharma is seeking a key account manager for drug product manufacturing at CMOs for the Ecaleret program (Calcilytix Therapeutics). The role leads manufacturing activities, transfer, batch disposition, and QA/CMC collaboration to ensure quality and timely DP production.

You will work with DP Formulation/CMC, Analytical Operations, Supply Chain, Quality Assurance, QA/QC, RA CMC and act as a technical contact between Calcilytix and CMOs, supporting commercial manufacturing at scale.

Qualifications

• BS/MS (Life Sciences, Engineering) with at least 5-7 years relevant experience in commercial bulk DP manufacturing.
• CMO management or experience within manufacturing plant.
• Experience in formulation development, process validation and tech transfer in support of marketing applications.
• Project leadership experience with cross-functional CMC experience.
• Knowledge of FDA/ICH guidelines and cGMP requirements.
• Understanding of supplier performance management and KPI metrics.
• Strong communication and time management skills.
• Willingness to travel up to 25%.

Responsibilities

• Oversee day-to-day activity of commercial DP CMOs for small molecule solid-oral dose manufacturing and release.
• Hold teleconferences with CMO and suppliers; track action items and create workflows for complex CMC procedures.
• Lead or support documentation review and approval (MBRs, specs, methods), and changes controls.
• Oversee investigations related to deviations and complaints with root cause analysis and CAPA.
• Collaborate with CMC/QA/QC/RA CMC functions to develop and operate CMC procedures.
• Work with supply chain to design production schedules maximizing efficiency.

Skills

5-7 years experience

CMO management experience

Formulation development

Project leadership

FDA/ICH knowledge

Supplier performance management

Communication skills

Time management

Travel willingness

Education

BS/MS in Life Sciences or Engineering

Job description

BridgeBio Pharma is seeking a key account manager for drug product manufacturing at CMOs for the Ecaleret program (Calcilytix Therapeutics). The role leads manufacturing activities, transfer, batch disposition, and QA/CMC collaboration to ensure quality and timely DP production.

You will work with DP Formulation/CMC, Analytical Operations, Supply Chain, Quality Assurance, QA/QC, RA CMC and act as a technical contact between Calcilytix and CMOs, supporting commercial manufacturing at scale.