Drug Substance Working Group Lead (Principal Scientist) - Netherlands
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- Our company is a global healthcare 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 Global Vaccines and Biologics Commercialization organization (GVBC) supports commercialization of vaccines and biologics.
- Furthermore, GVBC has a crucial role in supporting corresponding Lines of Business (LoB), Global Technical Operations (GTO), and the Quality organizations.
- These teams are regionally responsible for introducing new processes (BPDC) and analytical methods (ADV) into the commercial operations space and for support to LoB, GTO, and Quality.
- Reporting into the BPDC Director the Drug Substance Working Group Lead (Principal Scientist) is responsible for successful, on budget and on time management of pipeline Drug Substance program activities such as process tech transfer), process implementation at manufacturing scale, process performance qualification (PPQ) and filing support at regional commercial manufacturing sites.
- The position will have no direct reports, but functional reporting lines by DS team.
Roles and responsibilities:
- Leads a multidisciplinary team (members of e.g. BPDC, Technical Operations, Quality, analytics, and Regulatory) to manage successful Tech Transfer and process qualification (PPQ) at manufacturing scale; including complex investigations;
- Responsible for pro-active communication and reporting of program (e.g. progress, risks, mitigation) to stakeholders (e.g. functional management and global project teams);
- Responsible for alignment between stakeholders regarding program related discussions;
- Responsible for detailed project plan, estimated FTEs requirements, estimate of CRO costs, raw material costs, including milestones (project metrics) of activities;
- Participates in strategy meetings to guard end-to-end product focus;
- Coordination and review of technical reports, CMC modules and responses to questions from authorities;
- Participates, as subject matter expert, in regulatory inspections and is experienced with the cGMP and regulatory guidelines.
PhD in biological sciences, biochemistry, or biochemical engineering highly preferred; Bachelor's Degree required;
- At least 10 years of relevant experience in managing biotechnological development projects (after PhD);
- Experience in people management is a strong plus;
- Relevant cell culture, purification development and protein chemistry experience preferred;
- In-depth understanding of the product development trajectory (including cross-functional relationships);
- Demonstrated initiative, and innovative process-oriented thinking within a team environment;
- Knowledge of regulatory and quality guidelines, and knowledge on CTD format for IND/ BLA/ MAA submissions preferred;
- Experience in manufacturing sciences preferred;
- Strong communicator and ability to build bridges between groups and organizations;
- Excellent oral and written communication skills in English;
- Flexible attitude of problem solving and conflict avoidance.
- Our company is working to help the world be well.
- Through our medicines, vaccines, biologic therapies and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals.
- We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them.
- Our company has a workforce of almost 4500 in the Netherlands at three main sites.
- Our company Animal Health develops and produces vaccines and pharmaceutical specialties for livestock, companion animals and fish.
- We have offices in more than 50 countries, sell our products in over 140 markets and operate in a network of manufacturing sites and research and development facilities around the world.
- We are always seeking innovative talents that focus on constant improvement of our products and the way we work. We’re looking for new colleagues who are entrepreneurs and result driven.
- But not only results matter; how you achieve these results is crucial to be successful within company Animal Health as well.
- Our company Animal Health leads the way in veterinary pharmaceuticals.
- 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.
A good place to work
- Our company is an attractive employer offering interesting opportunities in Research & Development, production and staff departments for an enormous range of disciplines such as biologists, chemists, process engineers, technicians, mechatronic engineers, pharmacists and operators.
- Our company always seeks ‘best-in-class’ employees at all levels.
- We expect a lot from our people and company has a lot to offer them as well.
- Team spirit, entrepreneurship, integrity, leadership and cross-border communication skills are what company values and rewards most.
- If you enjoy being challenged, over and over again, our company will be a good place for you to work.
- We have an excellent fringe benefit program, and we invest heavily in the development of our people.
- Our company gives you plenty of opportunities for individual initiative and responsibility.
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