Drug Substance Working Group Lead (Principal Scientist) - Netherlands
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- 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 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. For pipeline Biologics, the BPDC organization is responsible for tech transfer, implementation and validation (PPQ) of the process at regional commercial manufacturing sites.
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.
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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