- Merck & Co. (Rahway, NJ)
- …productsLead capacity and utilization modeling across internal and external nodes, including Drug Substance (DS), Drug Product (DP), packaging, and storage.Drive ... on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other… more
- Merck & Co. (Rahway, NJ)
- …Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP). - Act as subject ... on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other… more
- Merck & Co. (Rahway, NJ)
- …data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes ... stakeholdersPosition Specific Required Skills and Experience: US and/or worldwide drug or vaccine regulatory application submission experience including the… more
- Merck & Co. (Rahway, NJ)
- …specific role will be responsible for advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible ... risks worthy of escalation versus typical uncertainty associated with drug development, commercialization, and/or supply. Productive Communication :--Plans and… more
- Merck & Co. (Rahway, NJ)
- …Quality.As part of Our Company's Manufacturing Division, within the Biologics Drug Substance Commercialization (BDSC) organization, the upstream process science and ... and biologics. The group supports various cell bank and upstream drug substance process commercialization activities and second generation process development… more
- Merck & Co. (Rahway, NJ)
- …compliance gaps are identified, assist designing solutions and implement enhancements.Manage the Drug Substance Drug Product (DSDP) tool and the VCP and ... on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other… more
- Merck & Co. (South San Francisco, CA)
- …leading cross-functional research initiatives.Understanding of regulatory requirements in drug development.Exposure to emerging AI techniques, such as reinforcement ... on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other… more
- Merck & Co. (North Wales, PA)
- …: This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of one or ... (SOPs) and software development life-cycle (SDLC) US and/or worldwide drug or vaccine regulatory application submission experience including the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and data capture to support CDx regulatory submission or associated drug regulatory submissions. Contributes to CDx Partner evaluation and selection activities ... IHC, PCR etc requiredAn understanding of how diagnostic development can shape drug development and commercialization is a plus. Competencies:Ability to work in a… more
- Merck & Co. (Rahway, NJ)
- …of actions.Experience in analysis of various Biologic modalities (eg, mAb, antibody- drug conjugate, fusion protein).Knowledge and experience in Antibody Drug ... on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other… more