[Remote] CMC / Technical Operations Program Manager - Associate Director

Note: The job is a remote job and is open to candidates in USA. Sobi is a biopharmaceutical company dedicated to developing innovative therapies for rare diseases. They are seeking an Associate Director for the CMC / Technical Operations Program Manager role, responsible for leading cross-functional teams and managing key CMC deliverables to ensure timely and budget-compliant project execution.

Responsibilities

• 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, in particular:
• Facilitates the setting and tracking of program objectives and priorities and monitors program progress against approved project plans (ensures we deliver on time and on budget)
• Coordinates 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
• Other job related tasks

Skills

• 10+ years of pharmaceutical industry experience
• Significant hands-on experience in CMC Development and Program/Project Management roles in complex environments and 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, with ability to organize, prioritize and follow-up
• 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
• Strategy and operational excellence minded with the ability to quickly define key program priorities, risks and issues, and lead teams in focusing on urgencies and solutions of greatest importance
• Outstanding relationship building and communication skills, including ability to navigate throughout the organization and with individuals at all levels both internally and with external partners
• Ability to lead, manage, develop, and motivate others in a matrix organization and in a changing environment
• Structured and analytical

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
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
• This role is eligible for both short-term and long-term bonuses, as outlined in the plan details
• We offer a competitive benefits package, to support the health and happiness of our staff

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