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Director Biologic and Vaccines Analytics Netherlands,
Posted on : 22 April 2017
- 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.
- Reporting into the Executive Director Biologic 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.
- You will have budget accountability for the BVA organization.
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.
- Accountable for providing technical and scientific support to new commercial biologic (e.g. technical support/trouble shooting) in EU area including company's 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.
- Accountable for the cGMP quality of all BVA deliverables including input in deviations, and change management according to company s quality system;
- Ensuring full tractability of data and reports in line with current requirements including Technical Knowledge Management;
- Accountable for department s compliance (EHS/Q).
- 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.
- Ensuring that BVA organization delivers high quality support to all filings;
- Accountable for Analytical related RtQs from HAs regarding filing content with BVA accountability
- 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.
- Experience in drafting product registration files;
- Experience in analytical sciences;
- Communication skills in Dutch.
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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