[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.ResponsibilitiesLead 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 executionProject 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 plansAssure 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 plansBuild holistic, scientifically sound and relevant scenarios as decision proposal at all governance levelsCoordinate 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 teamResponsible 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 addressedFollow the invoices and confirm the corresponding work execution to the budget ownerOther job related tasksSkills10+ years of pharmaceutical industry experienceSignificant 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 settingExcellent Project management skills: Decision- and action-oriented to facilitate quick decisions in alignment with all stakeholders, with ability to organize, prioritize and follow-upExperience in managing detailed program timelines to ensure timely delivery of key milestones and keeping oversight on complex projects budgetsIdentify and evaluate risks associated with project activities and take appropriate actions to control or mitigate risksScientific and technical background of CMC development and manufacturing in drug substance small molecule, no-sterile productsDemonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision makerHigh level of flexibility and effectiveness in cross-functional, international, and cross-regional environmentsProven ability to adapt to an ever-changing business environmentFluent in English, intermediate to full proficiency in Chinese is a plusStrategy 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 importanceOutstanding relationship building and communication skills, including ability to navigate throughout the organization and with individuals at all levels both internally and with external partnersAbility to lead, manage, develop, and motivate others in a matrix organization and in a changing environmentStructured and analyticalBenefitsCompetitive compensation for your workGenerous time off policyOpportunity to broaden your horizons by attending popular conferencesEmphasis on work/life balanceCollaborative and team-oriented environmentMaking a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsThis role is eligible for both short-term and long-term bonuses, as outlined in the plan detailsWe offer a competitive benefits package, to support the health and happiness of our staffCompany OverviewSobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. It was founded in 1988, and is headquartered in Solna, Stockholms Lan, SWE, with a workforce of 1001-5000 employees. Its website is http://www.sobi.com/en.