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Sobi
12d ago

External Manufacturing Manager(m/w/x)

Basel
Full-timeWith Home OfficeSenior

Description

As an External Manufacturing Manager, you will play a vital role in managing relationships with contract manufacturers and laboratories, ensuring the timely delivery of high-quality medicines while collaborating with cross-functional teams to drive operational excellence.

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Requirements

  • University degree in Manufacturing, Supply Chain, or relevant field
  • Minimum 5 years’ experience in pharmaceutical or life science industry
  • At least 2 years’ experience in coordinating roles, including project management
  • Hands-on experience with digital systems and good knowledge of MS Office
  • Previous experience working directly with CMOs, CLOs, or external partners
  • Strong understanding of cGMP manufacturing of biologics and/or small-molecule pharmaceuticals
  • Ability to thrive in a cross-functional, matrixed, and global environment
  • Excellent verbal and written English communication skills
  • Excellent verbal and written Swedish
  • Verbal and written skills in Chinese or Japanese is highly desired
  • Negotiation skills

Education

Bachelor's degree

Work Experience

5 years

Tasks

  • Lead cross-functional Virtual Plant Teams
  • Act as the main point of contact for assigned CMOs and CLOs
  • Drive strategic and operational management of CMOs and CLOs
  • Conduct Business Reviews and Operational Meetings
  • Manage supplier relationships and ensure compliance with supply agreements
  • Oversee change orders and improvements for OTIF delivery
  • Participate in sourcing and evaluating new contract manufacturers
  • Develop supply and quality agreements
  • Contribute to internal activities related to external manufacturing
  • Manage change management and critical deviations
  • Oversee CAPAs and related processes
  • Issue, review, and approve relevant SOPs and manufacturing instructions
  • Review applicable sections of APR and PQR
  • Provide budget input for CMO and CLO-related costs
  • Ensure adherence to budget for external manufacturing activities

Tools & Technologies

MS Office

Languages

EnglishBusiness Fluent

SwedishBusiness Fluent

ChineseBasic

JapaneseBasic

Benefits

Competitive Pay

  • Competitive compensation

Family Support

  • Emphasis on work/life balance

Informal Culture

  • Collaborative and team-oriented environment

Career Advancement

  • Opportunities for professional growth

Other Benefits

  • Diversity and Inclusion

Purpose-Driven Work

  • Positive impact on ultra-rare disease patients
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