The senior manager (pm) will be responsible for supporting technology transfer teams, on several biologic and/or synthetic drug substance and drug product external manufacturing projects of different clinical phasesHe/she interfaces directly with the tech transfer lead and will be a critical member of the vendor facing joint project team (jpt)He/she works with the project teams’ members to gather standardized information on project, scope, milestone tracking, and riskThe incumbent is a highly organized, detail oriented, highly adaptable individual who represents the broader cmc program management organization in their interaction with internal and external teams and stakeholders at multiple levels of managementThis position will coordinate and manage international external manufacturing projects and validation campaigns for the product development and clinical supply (pdcs) organization and works closely with the overall cmc program manager to ensure best practices and integrate project milestones and deliverables into the integrated cmc program plan.
Principal responsibilities
Creates detailed, tactical, ms project gantt charts that track project deliverables and milestones associated with technology transfer projects and process validation campaigns
Attend and contribute to the cmc execution team, as required, to ensure seamless integration and visibility to project milestones within the broader cmc program timeline
Communicates clearly and effectively to ensure project execution progresses per schedule.
Strives to ensure that all parties understand roles and responsibilities to deliver on project objectives
Collaborates frequently with external partner/cmo project managers and internal multi- discipline subject matter experts.
Supports and drive the tech-transfer teams through the tech-transfer stage-gate process
Utilizes and maintains tracking tools for multiple project milestone and resource allocation modelling.
Updates the project schedules—tasks, resources, percent complete, dependencies, etc.
Updates and maintains internal project status tools, such as a project action logs, risk registers, and contributes relevant data to cmc program & portfolio dashboards
Schedules team meetings and assists with creating meeting agendas, meeting minutes and other facilitation materials
Assists in the development & formatting of project updates and communications
Qualifications
5-10 years experience in the biotech/biopharmaceutical industry working in a matrix environment
Experience working with external partners/contract manufacturing partners
Mastery of microsoft project; knowledge of ms project server a plus
Understanding of pmi’s or similar project management methodologies
High level of proficiency in ms office software including: word, excel, outlook, visio, and powerpoint
Excellent written and oral communication skills
Education
Bachelor’s degree in science or business discipline
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Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change livesAt alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseasesThese patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicinesAs a leader in rare diseases for more than 25 years, alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (achr) antibody-positive generalized myasthenia gravis (gmg) and neuromyelitis optica spectrum disorder (nmosd)Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (hpp) and lysosomal acid lipase deficiency (lal-d) as well as the first and only approved factor xa inhibitor reversal agentIn addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for wilson disease, an anti-neonatal fc receptor (fcrn) antibody for rare immunoglobulin g (igg)-mediated diseases and an oral factor d inhibitor as well as several early-stage therapies, including one for light chain (al) amyloidosis, a second oral factor d inhibitor and a third complement inhibitorAlexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiologyHeadquartered in boston, massachusetts, alexion has offices around the globe and serves patients in more than 50 countriesFurther information about alexion can be found at: www.alexion.com .
