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Chengdu, Sichuan, China · On-site
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Guaduas, Cundinamarca, Colombia · Hybrid
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Directs technology and process development for the Large Molecule vaccine portfolio, focusing on discovery, pre-development, and transfer to manufacturing. Leads multiple projects involving scale-up, commercialization, and the implementation of new platform technologies.
Requires a Master's degree or higher in a relevant biological or engineering field with at least 3 years of experience in biopharmaceutical process development. Must have hands-on expertise in upstream process technology and familiarity with aseptic manufacturing and statistical analysis.
Job Description
Responsible for directing technology development, process development, and process improvement of the Large Molecule (LM) vaccine portfolio for all species. Activities are carried out in local projects with high complexity covering the discovery, pre-development, and development phase as well as transfer from R&D to Manufacturing, licensing, and implementation .
Independently setting up and executing a project, focusing on processes for the development of new products, improvement of existing products, or solving problems in the production of existing products.
Works together with Quality departments, Manufacturing LM site, R&D species teams, Discovery & Technology, Product stewards, Regulatory Affairs, Procurement, Supply Chain, and Network strategy to achieve our company AH business goals.
Fulfilling research project management skills, research design, reporting, and presenting project (progress) reports.
Interacting closely with fellow scientists within and other departments
Leads or co-leads at least a minimum of 2 projects at any given time, including the pre-development, pilot scale-up, transfer & commercialization, and provides technical support on the site.
Is responsible for independent planning and executing a project/experiment. Can provide coordinating and substantive guidance on projects.
Ensure regular, adequate, and complete reporting of the research carried out.
Drives research on all used platform technology (e.g., bioreactor technology, RB, egg-based, RP, and Perfusion, formulations, emulsion, and Freeze-drying technology, etc.). This comprises the development of serum-free media, in vitro test development, improved downstream processes, new hardware for USP and DSP, single-use component technology, etc.
Executes and owns regulatory documents such as study reports, OOP, batch records, SOPs, and MMIs for new drug applications, production departments, and Quality.
Leads or members of transfer teams responsible for the transfer of production processes from site to site, and R&D to Manufacturing.
Conducts literature study in connection with current or future projects.
Communication and exchange of know-how between global BTS departments and Global R&D and Manufacturing to benefit from synergies and optimize utilization of knowledge and technology.
Operational responsibility for the development of improved processes (upstream and downstream) and resolving manufacturing and supply issues of our vaccine portfolio according to the needs of Manufacturing.
Co-leads or supports major Method development projects with a high degree of independence, in cooperation with R&D and Quality partners as appropriate
Drives identification, feasibility assessment, and supports implementation of new technologies in cooperation with R&D and Quality partners
Performs co-development/Single POC activities with a high degree of independence
Master's degree or above in a relevant field (e.g., Biology, Virology, Veterinary sciences, Biotechnology, Bacteriology, Bio-Engineering, and Molecular biology, etc.) with a minimum of 3 years of work experience in research institutes, universities, or the biopharmaceutical industry involving LM process development, assay development, method validation, technology transferring, etc.
Practical knowledge and hands-on expertise regarding LM upstream process technology for biopharmaceuticals at laboratory and manufacturing scale, e.g., cell/viral culture, bioreactor, filtration, and/or purification process.
Familiar with aseptic biopharmaceutical manufacturing process technologies, including any pilot scale, scale up/down, Design of Experiments (DoE), and statistical analysis to support the decision-making.
Well-versed with good documentation practice and technical writing.
Good interpersonal, collaborative, and verbal/written communication skills, well organized, and able to work independently and make decisions in a team environment.
Good conceptual, analytical, problem-solving, and critical thinking skills.
Self-motivated and value-driven.
Quality management and GMP knowledge in the biopharmaceutical industry (preferred).
English Language skills, verbal and written (preferred).
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
