Rentschler Biopharma Inc.
Associate Director, CMC Project Leadership
Rentschler Biopharma Inc., Milford, Massachusetts, us, 01757
Associate Director, CMC Project Leadership
Apply locations: Milford, MA, United StatesTime type: Full timePosted on: Posted 3 Days AgoJob requisition id: JR1904Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.We are a family-owned company with approximately 1,400 employees from 25 nationalities. What unites us at Rentschler Biopharma is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!Duties and ResponsibilitiesPrincipal Responsibilities:Development and maintenance of strong relationships with our clients, while ensuring successful delivery of our services.Independent, active and hands-on management of multiple client projects with medium to high complexity.Day-to-day key contact for client for all topics related to project; maintain close contact with clients by providing frequent project updates, transmission of project related data, and overall management of client expectations.Lead cross-functional CMC teams with subject matter experts from Process Sciences, MSAT, Manufacturing, QC and QA, Supply Chain and Regulatory as well as corresponding client team members.Develop project strategy and goals with CMC team/client; advise clients on strategic alternatives for project implementation.Develop project schedules, ensuring commitment to project task and milestone deliverables from team members and functional managers.Escalate when timelines are not being met and when barriers and roadblocks occur.Responsible for preparation and maintenance of project plan as well tracking of the overall project plan & budget; follow up on work packages and associated payment milestones.Preparation of project amendments together with business development and proposal management.QualificationsMinimum of bachelor’s degree in science, engineering, or related discipline.5+ years of professional experience in the development and/or manufacturing of biopharmaceuticals with a primary focus on project/program management of CMC related activities.At least 3 years of project management experience; experience in a CDMO environment preferred.Experience in leadership of cross-functional matrix teams driving strategy, planning and project execution in a dynamic environment with rapidly changing priorities.Experience utilizing project management tools and best practices to support CMC activities.Strong communication, problem solving and conflict resolution skills to facilitate development of solutions to complex issues internally and with client.Must have integrated view of business and technical issues.Strong intercultural competence: ability to build sustainable relationships with international business partners.Ability to read and understand project contracts and deliverables.Self-starter and must function well under minimal supervision.
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Apply locations: Milford, MA, United StatesTime type: Full timePosted on: Posted 3 Days AgoJob requisition id: JR1904Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.We are a family-owned company with approximately 1,400 employees from 25 nationalities. What unites us at Rentschler Biopharma is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!Duties and ResponsibilitiesPrincipal Responsibilities:Development and maintenance of strong relationships with our clients, while ensuring successful delivery of our services.Independent, active and hands-on management of multiple client projects with medium to high complexity.Day-to-day key contact for client for all topics related to project; maintain close contact with clients by providing frequent project updates, transmission of project related data, and overall management of client expectations.Lead cross-functional CMC teams with subject matter experts from Process Sciences, MSAT, Manufacturing, QC and QA, Supply Chain and Regulatory as well as corresponding client team members.Develop project strategy and goals with CMC team/client; advise clients on strategic alternatives for project implementation.Develop project schedules, ensuring commitment to project task and milestone deliverables from team members and functional managers.Escalate when timelines are not being met and when barriers and roadblocks occur.Responsible for preparation and maintenance of project plan as well tracking of the overall project plan & budget; follow up on work packages and associated payment milestones.Preparation of project amendments together with business development and proposal management.QualificationsMinimum of bachelor’s degree in science, engineering, or related discipline.5+ years of professional experience in the development and/or manufacturing of biopharmaceuticals with a primary focus on project/program management of CMC related activities.At least 3 years of project management experience; experience in a CDMO environment preferred.Experience in leadership of cross-functional matrix teams driving strategy, planning and project execution in a dynamic environment with rapidly changing priorities.Experience utilizing project management tools and best practices to support CMC activities.Strong communication, problem solving and conflict resolution skills to facilitate development of solutions to complex issues internally and with client.Must have integrated view of business and technical issues.Strong intercultural competence: ability to build sustainable relationships with international business partners.Ability to read and understand project contracts and deliverables.Self-starter and must function well under minimal supervision.
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