CMC Project Lead: API Delivery & Client Impact

Bachem

Torrance (CA)

On-site

USD 109,000 - 149,000

Full time

14 days+
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Benefits offered by this job

Annual bonus
Medical/Dental/Vision coverage
401(k) with employer contribution
Paid vacation and sick days

Job summary

Bachem Americas is seeking a CMC Project Leader to coordinate API manufacturing campaigns for biotech and pharmaceutical clients. You will lead cross-functional teams, negotiate contracts, forecast, and ensure timely delivery while maintaining compliance and maintaining strong client relationships.

The role requires deep knowledge of CMC, GMP, and regulatory filings, with a focus on driving project success and expanding business opportunities.

Qualifications

  • Bachelor's Degree in Science (Chemistry, Biochemistry, Bioengineering or similar) required.
  • Master's Degree in Science (Chemistry, Biochemistry, Bioengineering, or similar) required or MBA/ PMP preferred.
  • PhD in Science (Chemistry, Biochemistry, Bioengineering, or similar) preferred.
  • Minimum 6 years' experience in (bio-)pharma/CDMO/chemical industry with bachelor's degree required or
  • Minimum 4 years' experience in (bio-)pharma/CDMO/chemical industry with master's degree required.
  • Minimum 2 years' experience in customer-facing role or CMC project management required.
  • Basic knowledge of clinical development and GMP; familiarity with drug substances characterization (HPLC, LC-MS, etc.)
  • Experience with different customer types and contract knowledge (NDAs, Supply & Quality Agreements).
  • Certified Project Management Professional (PMP) preferred.

Responsibilities

  • Lead project teams (3-10 internal and additional external members) for customers and R&D operations.
  • Act as business lead in negotiations, proposals and forecasting.
  • Ensure scope adherence and timely deliverables per customer contracts.
  • Be the go-to person for project-related tasks and issues.
  • Structure and monitor activities with the project team using available tools.
  • Represent Bachem to customers' senior/executive leadership.
  • Report accurate project data in CRM and document systems.
  • Partner with senior leadership to secure capacity and support.
  • Create accurate documentation (minutes, plans, actions, summaries).
  • Identify opportunities to expand scope and drive additional business.

Skills

Leadership
Cross-functional collaboration
Communication
Project management
Financial acumen

Education

Bachelor's Degree in Science
Master's Degree in Science/MBA
PhD in Science (preferred)

Tools

Salesforce
MS Office
MS Project
Master Control
SharePoint/ShareFile
SAP

Job description

Bachem Americas is seeking a CMC Project Leader to coordinate API manufacturing campaigns for biotech and pharmaceutical clients. You will lead cross-functional teams, negotiate contracts, forecast, and ensure timely delivery while maintaining compliance and maintaining strong client relationships.

The role requires deep knowledge of CMC, GMP, and regulatory filings, with a focus on driving project success and expanding business opportunities.

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