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SOSobi

External Manufacturing Manager(m/w/x)

Basel
Full-timeWith Home OfficeSenior

Leading virtual plant teams, managing contract manufacturing and lab partners for rare disease biopharmaceuticals. 5 years pharma/life science industry experience, direct CMO/CLO management required. Work in specialized rare disease biopharma, leading virtual plant teams.

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

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

Work Experience

  • 5 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • SwedishBusiness Fluent
  • ChineseBasic
  • JapaneseBasic

Tools & Technologies

  • MS Office

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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sobi and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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