CMC Technical Project Manager
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POST DATE 7/2/2020
END DATE 8/15/2020
Vertex Pharmaceuticals Inc (US)
JOB DESCRIPTIONIn June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat and even cure several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.
VCGT is looking for a Technical Project Manager to join its growing team. The role will be responsible for managing the development plan and CMC department interfaces (internal and external) as part of the CMC Program Management team. The Senior Technical Project Manager will work closely with the Cell, CMC, Clinical, Preclinical, and Quality teams to meet program milestones. The position will be based in Cambridge, MA.
* Work independently and with the team to develop a cross-functional development plan from current stage through product launch.
* Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies.
* Build and sustain robust business processes to support cross-functional clinical trial execution.
* Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
* Facilitate regular project team meetings, issue written minutes, and follow up on action items.
* Maintain overall project dashboard, schedule, budget, project plans, operational plans, and routine reports to sponsors and stakeholders.
* Represent company to external partners groups as required.
* BS in life sciences, bio-engineering, or related discipline with minimum 5 years relevant work experience.
* 2+ years of demonstrated project management and change management experience in a clinical pharma/biotech setting.
* Experience in either preclinical or early clinical phase company with hands on experience in GXP environment.
* Strong interpersonal skills to elicit, synthesize, and manage the cross-functional inputs required for a robust development plan.
* Ability to communicate effectively with a diverse range of scientists, physicians, engineers, regulatory specialists and business professionals.
* Entrepreneurial spirit with a team attitude, demonstrated leadership skills and an ability to integrate across all company projects.
* Experience in cell therapy or gene therapy or combination products.
* PMP certification.
* Regulatory experience.