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Drug Substance Working Group Lead (Principal Scientist) Netherlands,  


Posted on : 10 April 2017

Project Description

Drug Substance Working Group Lead (Principal Scientist) - Biotech-PRO014568DescriptionFor our GVBC/ BPDC (Biologics Process Development & Commercialization) organization in Oss we are currently looking for a:Drug Substance Working Group Lead (Principal Scientist) - BiotechAbout MSDMSD 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.MSD. Be well. For more information, visit our website: www.werkenbijmsd.nlThe departmentThe 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. As part of the GVBC organization, analytical and process Centers of Excellence are located in the US and Oss, the Netherlands. 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 Oss BPDC organization is responsible for tech transfer, implementation and validation (PPQ) of the process at regional commercial manufacturing sites (including MSD-Oss and CMOs located in Europe). In addition, BPDC Oss is responsible for deep scientific support to investigations (trouble shooting and process improvements).The positionReporting 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 (including MSD-Oss and CMOs located in Europe). 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.Qualifications* 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 workOur employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable reward 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 livesInformationFor more information about this position you can contact Wout van Grunsven, Director Engineering Biotech BPDC, by phone: 0412-661251.ApplicationIf you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.Recruitment Agency / Search Firm representatives please note:MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.Job: Process Engineering Job Title:Drug Substance Working Group LeadPrimary Location: EMEA-Netherlands-NB-OssEmployee Status: RegularTravel: NoNumber of Openings: 1Company Trade Name:MSD Job Segment: Biotech, Chemistry, Biochemistry, Law, Scientific, Science, Legal, Engineering

Locations

Oss NL

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