- Eisai, Inc (Raleigh, NC)
- …the drug development process.Significant experience with manufacturing operations, biologics , and aseptic manufacturing.Experience with highly automated parenteral ... manufacturing processes, including isolators, automated inspection, Manufacturing Execution Systems and electronic batch release.Competent in analyzing complex products, production, and testing issues.Demonstrated scientific problem-solving capabilities.Direct… more
- Eisai, Inc (Raleigh, NC)
- …you. Essential Functions Provides technical and administrative management oversight for the Biologics division within Tech Ops for US based staff and operations. ... Works to establish and implement appropriate business plans with the Tech Ops Director , Unit Sr. Director and/or Unit Head.Proactively promotes and coordinates… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations… more
- Merck & Co. (Rahway, NJ)
- …as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the ... of formulationsThe Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving… more
- BioAgilytix (San Diego, CA)
- …to the patients who need them.Join our esteemed team at BioAgilytix as the Director , Business Development, where you will play a pivotal role in driving our ... Working knowledge of selling GMP CMC analytical development and testing services for biologics and cell and gene therapies is preferred.As the Director of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... advisory letters, enforcement letters and policy issues affecting the pharmaceutical/ biologics industry. Communicate significant changes in FDA perspective to… more
- Tris Pharma (Monmouth Junction, NJ)
- Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc. ... Junction, NJ headquarters has an immediate need for an experienced Associate Director / Director , Analytical Research & Development. Job Title commensurate with… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate ... Director .This position will have overall responsibility for oversight and...of the Senior Leadership Team for the Millsboro, DE biologics manufacturing site.Lead numerous projects including process improvement and… more
- Merck & Co. (Rahway, NJ)
- Job Description Director -QP2-IO We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology ... (QP2-IO) team in the role of Director . QP2-IO team is part of the Global Clinical...understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs), and local country ... with the PSL(s) to plan and prioritize activities for Biologics License Applications (BLAs)/Marketing Authorisation Applications (MAAs), and local country… more
- Genmab (Plainsboro, NJ)
- …fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development of ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member ... required Demonstrated knowledge of global regulatory requirements for drugs and biologics Proven ability to develop robust regulatory strategies required Experience… more
- Merck & Co. (North Wales, PA)
- …and Technical Skills:People change management experienceTechnical experience with vaccines, biologics , and / or cell gene therapy productsTechnical Operations, ... Quality operations and/or compliance experienceDemonstrated effective leadership, communication, interpersonal and negotiating skills, in particular with cross functional partnersAbility to learn and understand technical aspects of new processes to ensure… more
- Merck & Co. (Rahway, NJ)
- …understanding of regulatory agency regulations and requirementsExperience in Biologics and/or Vaccine method development, characterization, technology transfer, and ... releaseStrong scientific/ technical expertise, perspective and judgment in the selected subject matter area coupled with the ability to interact with scientific subject matter experts on various product initiativesAbility to independently interact with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience within a global pharmaceutical company with expertise in: oncology, biologics or vaccines.Must have proven expertise within Quality Assurance Research to ... support Global Research QA including activities under GLP, GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA functionMust have proven ability to lead and influence others within a global/matrix… more
- Merck & Co. (Rahway, NJ)
- …and commercial drug substance manufacturing processes for vaccines and biologics .-- BDSC supports second generation process development and various commercialization ... of regulatory submissions. -Under the general scientific and administrative direction of Director in BSS, this individual will support late stage and commercial… more
- Merck & Co. (Rahway, NJ)
- …pipeline and post-market commercial manufacturing processes for vaccines and biologics . CCFS supports various commercialization activities, second generation process ... of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and… more
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