Technical Operations Program Manager – Associate Director

Program ManagerProgram ManagerFull TimeRemoteSeniorTeam 1,001-5,000Since 1991H1B No SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

31 days ago

Salary

$153K - $211K / year

Seniority

Senior

Postgraduate Degree8 yrs expEnglish

Job Description

Technical Operations Program Manager – Associate Director

Sobi - Swedish Orphan Biovitrum AB (publ)

• Lead an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation supporting an approvable NDA Module 3 and translate technical & regulatory strategies into execution • Project manage all key CMC deliverables, incl underlaying reports, coordinate team interactions ensuring team meetings have structure and purpose, documents clear decisions/actions and communicates them to team members and relevant stakeholders, holds team members accountable for functional delivery of plans • Assure integrated program plans are in place including cross-functional interdependencies • Facilitates the setting and tracking of program objectives and priorities and monitors program progress against approved project plans • Coordinate the identification and mitigation of program issues and risks, assures risk mitigation plans • Build holistic, scientifically sound and relevant scenarios as decision proposal at all governance levels • Coordinate the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.) • Coordinates the preparation for governance and executive management program presentations in close collaboration with the leadership team • Responsible for program budget and long-term projections – budget planning and tracking, and evaluates project resource requirements: highlights resource gaps and works to ensure they are addressed • Follow the invoices and confirm the corresponding work execution to the budget owner

Job Requirements

  • > 8 years of pharmaceutical industry experience
  • Significant hands-on experience in CMC Development and Program/ Project Management roles in complex environments
  • Experience in working with cross-functional teams in the pharmaceutical industry, preferably in a global setting
  • Excellent Project management skills: Decision- and action-oriented to facilitate quick decisions in alignment with all stakeholders
  • Experience in managing detailed program timelines to ensure timely delivery of key milestones and keeping oversight on complex projects budgets
  • Identify and evaluate risks associated with project activities and take appropriate actions to control or mitigate risks
  • Scientific and technical background of CMC development and manufacturing in drug substance small molecule, no-sterile products
  • Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker
  • High level of flexibility and effectiveness in cross-functional, international, and cross-regional environments
  • Proven ability to adapt to an ever-changing business environment
  • Fluent in English, intermediate to full proficiency in Chinese is a plus.

Benefits

  • Competitive compensation for your work
  • Generous time off policy
  • Opportunity to broaden your horizons by attending popular conferences
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment

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