Scientist, Downstream – Biologics Drug Substance Commercialization

Job Description

We aspire to be the premier research-intensive biopharmaceutical company. Our manufacturing division is at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases. We are seeking a motivated scientist/engineer to join our Bioprocess Drug Substance Commercialization (BDSC) group. This role offers an exciting opportunity to work on late-stage process development, technology transfer, and in-line support of biologics.

• Lead the execution of hands-on experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and process scale-up/scale-down model development.
• Collaborate with commercial manufacturing teams as a process sciences representative to support facility start-up and in-line support activities, including on-the-floor support for drug substance manufacturing as needed.
• Author and/or review technical documents to support Process Performance Qualification (PPQ) and licensure.

Required

• Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline.
• 2+ years of experience with downstream processing of monoclonal antibody (mAb) products or similar products in a laboratory or manufacturing setting, including unit operations such as membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance.
• Mechanistic understanding of downstream processing separation sciences.
• Ability to execute experiments independently in a manner that meets quality and timeline expectations.
• Well-developed communication, organizational, and problem-solving skills, with an attention to detail.

Preferred

• Large molecule drug substance technology transfer experience.
• Collaboration with analytical teams, pilot-scale, and/or manufacturing environments.
• Experience authoring technical documentation in support of the following: process description, process characterization, process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.
• Current Good Manufacturing Practice (cGMP) awareness or experience. #Vet Jobs #EBRG's

Analytical Chemistry, Analytical Chemistry, Antibodies, Biologics, Biology, Biomolecular Chemistry, Bioreactors, Biotechnology, Biotechnology Manufacturing, Cell Culture Techniques, Chemistry, Clinical Manufacturing, Data Analysis, Design of Experiments (DOE), Detail-Oriented, Downstream Process Development, Downstream Processing, Experimentation, Good Manufacturing Practices (GMP), High-Throughput Screening, Interdisciplinary Collaboration, Maintenance Supervision, Medication Safety, Monoclonal Antibodies, Pharmaceutical Process Development {+ 8 more}

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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…