CMC Project manager/Senior Project manager - Gaithersburg, MD | Biospace
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CMC Project manager/Senior Project manager

MedImmune, LLC

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                                       Location:Cambridge, England, United Kingdom
Gaithersburg, Maryland, United States
Job reference: R-003695

Posted date: Feb. 14, 2017


   Title: CMC Project Manager / Senior Manager  


   Location: Cambridge, UK or Gaithersburg, USA  

   Title: CMC Project Manager / Senior Manager  

   Salary: Competitive  

   MedImmune is the global biologics research and development arm of AstraZeneca. We work as partners in bringing life changing medicines to patients, sharing and benefiting from each other's strengths.  


   Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities. that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/metabolic disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.  


   The CMC Project Manager works collaboratively with CMC Team Leaders and CMC Teams to ensure Biopharmaceutical Development (BPD) project goals and milestones are achieved by providing project management expertise to CMC Teams ensuring smooth and efficient operational implementation of CMC strategy, and enabling project delivery in line with time, financial and quality requirements. This role also leverages and applies operational management experience where appropriate to support alliances and collaborations and maintains, promotes and influences CMC project information systems and tools. The CMC PM may contribute on behalf of CMC Team Management to operational process development initiatives and may deputize for other managers. This role has a high job complexity and the successful candidate must have a high level of independence to meet requirements outlined above with minimal supervision.  

   In this role you will ensure effective integration of science, business and project objectives. You will manage BPD activities for specified projects at all development stages, interfacing with relevant functional groups, and with external suppliers as necessary, to plan and coordinate the timely execution of CMC activities and contingencies. You will lead and facilitate CMC Team meetings and be responsible for project logistics and documentation. You will also play a lead role, with the CMCTL ,in preparing CMC Teams for key aspects of governance review, with specific accountabilities related to project plans and budget. Where appropriate you will also act as alliance manager, partnering with internal / external partners as required to ensure effective management of the alliance or collaboration.  


   You will be expected to influence, develop, maintain, own and deploy all key project management tools and ensure that tools are used appropriately to enhance project delivery and information dissemination to the business.. You will also work as an interface internally and externally as required in evaluation of clinical and nonclinical material demand and provide appropriate planning, coordination and communication to enable supply of materials and information of the required quality standard. The role requires a high degree of collaboration with BPD functional representatives, harnessing creativity within cross-functional project teams to develop risk mitigation and contingency scenarios for projects.  


   Essential Requirements:  

  •      Bachelor's, Master's, PhD or equivalent industry experience in a relevant technical discipline such as Biochemistry, Molecular Biology, Microbiology, Genetics, Immunology or Chemical Engineering. Relevant training or experience in project management (PMP or equivalent).    
  •      Experience in planning and managing the cross functional aspects of biopharmaceutical product development.In particular, experience in managing CMC teams responsible for development of biopharmaceutical products is required.
  •      Demonstrated knowledge and application of Project Management tools, such as Risk Management.    
  •      Familiarity with Planisware 5 (Opal) or other project & portfolio management system    
  •      To be considered for hire at the Sr. Project Management level, it is expected that the candidate will have had an exceptional track record in a CMC Project Management role for development of a biopharmaceutical

   This position requires a high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations  

   Closing date: March 17th 2017  

   AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.