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Director Biologics and Vaccines Analytics Job Netherlands,  

MSD (company)


Posted on : 10 April 2017

Project Description


About Us:
  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us. 
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork. 
  • As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


The position
  • Reporting into the Executive Director Biologics and Vaccines Analytics  you will be responsible for analytical implementation at regional commercial testing sites.
  •  You will be responsible for assay robustness and life-cycle initiatives and deep technical support to investigations. 
  • You will have 5-10 direct reports, (Associate) Principal Scientists and analytical leads and so you will be responsible for an organization of approximately 20 -30 employees in total



Other tasks and responsibilities:
Analytical Tech Transfer
  •  Accountable for tech transfer of analytical methods to commercial manufacturing and testing facilities for testing of therapeutic proteins and potentially vaccines;
  •  Interfacing with late stage analytical development (GVBC BVA West Point/Research Labs), technical operations and analytical development peers to ensure efficient and effective transitions.

Technical/scientific leadership
  •  Accountable for providing technical and scientific support to new commercial biologics (e.g. technical support/trouble shooting) in EU area including  facilities, and globally as required;
  • Accountable for successful project management of relevant analytical programs;
  •  Accountable for the scientific quality and on-time delivery of analytical development studies and related documentation.

Compliance
  •  Accountable for the cGMP quality of all BVA deliverables including input in deviations, and change management according to  quality system;
  •  Ensuring full traceability of data and reports in line with current requirements including Technical Knowledge Management;
  •  Accountable for department s compliance (EHS/Q).

Innovation
  •  Creating and stimulating an open culture of high technical quality and innovation in the department;
  •  Accountable for implementing new analytical platforms in cross-functional late stage analytical development and QC teams.

Filing support
  •  Ensuring that  organization delivers high quality support to all filings;
  •  Accountable for Analytical related RtQs from HAs regarding filing content with  accountability

Qualifications

Required
  •  PhD in biological sciences, biochemistry, or biochemical engineering;
  •  At least 5-7 years of relevant experience in managing biotechnological analytical development projects and analytical tech transfer activities;
  •  Relevant experience with cGMPs and involvement with QC analytical activities;
  •  Relevant assay development, validation and protein chemistry experience;
  •  Proven strong scientific and project management skills;
  •  Knowledge of regulatory and quality guidelines;
  •  Full understanding of cGMPs and industry best practices in Quality functions, including method validation, transfer, lifecycle management and global business acumen;
  •  Excellent analytical and technical skills;
  •  Strong direct and indirect people management skills;
  •  Strong team builder and leader with mature and exemplary interpersonal skills;
  •  Demonstrated initiative and innovative process-oriented thinking within a team environment;
  •  Strong communicator and ability to build bridges between groups and global organizations;
  •  Excellent oral and written communication skills in English.


Preferred
  •  Experience in drafting product registration files;
  •  Experience in analytical sciences;
  •  Communiction skills in Dutch.



About Us:
  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us. 
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork. 
  • As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.



A good place to work
  • Our employees are the key to our company s success.
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. 
  • Our company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.



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Locations

Oss NL

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