Sr. Project Manager, Viral & Gene Therapy Manufacturing

Posted 19 Aug 2020

Carlsbad, California - United States

Req Id 209257

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Gene Editing & Novel Modalities (GENM) is one of three Promise Ventures within the Life Science Division of Merck, KGaA Darmstadt Germany. As a Promise Venture our mandate is to think big and reach across verticals to leverage the full capabilities of the Life Science organization. With the agility of startup and the resources of a leading multinational, GENM is applying a portfolio of advanced technologies, cell engineering expertise, cell and gene therapy manufacturing experience, and to transform the way researchers discover, develop, and manufacture novel, life changing gene and cellular therapies.  We seek a self-starting, passionate Sr. Project Manager with the analytical and creative skills needed to execute effective Project Management.

 

Your role:

You will manage business critical projects and business relationships across the GENM organization. You will be the primary contact for our customers who we are providing contract manufacturing and testing projects.  You are responsible for maintaining client satisfaction during the execution phase of the contract and also maintaining clear expectations with internal stakeholders.  You will drive and collaborate with the internal teams including Manufacturing, QA, QC, PD, Testing and Sales to ensure that contractually agreed upon specifications and deliverables are met.  Additionally, you will support the execution of the Virus & Gene Therapy (VGT) Project Management Office (PMO) mission and vision.  Additional responsibilities include:

 

  • Identify and communicate to team when scope of work changes has been identified as necessary and are agreed to by the client.
  • Prepare management reports to report on client satisfaction, success of prior projects in terms of resource allocation, project profitability, and gap analyses for continuous improvement.  Communicate to the Director of Program Management, Business Development and Sr. Management any issues that may affect contract performance and execution.
  • Ensure that billing milestones are forwarded for proper and timely invoicing.
  • Maintain SharePoint system (CorasWorks) with exceptional accuracy.
  • Provide input on prospective contracts for ability to meet deliverables based on projected resource utilization.
  • Participate in integration activities within the Life Science Services Unit including, but not limited to, BioReliance testing

 

Who You Are:

Minimum Qualifications:

  • Bachelors Degree in related Science.
  • 5+ years post-educational working experience in biology, chemistry, engineering or related field.  
  • 7+ years Project Management experience with a focus on global projects in a cGMP regulated environment with a high level of technical complexity.
  • Technical understanding of biological systems including manufacturing, process development, product assays, and testing.
  • Working knowledge of Process Validation of Biomanufacturing systems.
  • Proven experience managing late stage, commercially viable programs.
  • Experience and working knowledge of FDA regulated Quality systems.
  • Experience in Stage Gate Processes (PDP).

 

Preferred Qualifications:

  • PMP® certification
  • Previous exposure to gene editing concepts.
  • Demonstrated ability to manage stakeholders and influence contributors across a variety of levels.
  • Adept at both navigating the complexities of a large organization and within a start-up environment.
  • Previous work experience in international and multidisciplinary project teams.
  • Agility, flexibility, adaptability due to shifting landscape of priorities.
  • Strong verbal and written communication skills with a high level of attention to detail and decision-making skills.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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