- Novo Nordisk Inc. (Boulder, CO)
- …is seeking a highly experienced and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of ... Drug Product Manufacturing is accountable for clinical phase 1...pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and maintaining ... procedures, and all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug product release… more
- Tris Pharma (Monmouth Junction, NJ)
- …projects. The incumbent ensures thorough characterization of formulations and drug delivery technologies under development and builds in-house analytical ... and regulatory packages per International Council for Harmonization (ICH)/Food and Drug Administration (FDA) guidance and provides technical guidance within and… more
- Merck & Co. (North Wales, PA)
- …worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.Provides ... compounds or marketed products throughout the entire life cycle of the drug .Provides leadership as head of the Global Regulatory Team, which coordinates… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient ... drug discovery/development and/or regulatory decisions. The Pharmacometrics group within...more novel quantitative approaches that seek to improve cycle time , cost/size, number of trials, clinical trial design and… more
- Merck & Co. (Rahway, NJ)
- …solving complex problems. Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or ... is desirable. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and...members are assigned to the program with the right time commitment, raising resource concerns in real- time … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …We are currently seeking a Biostatistics Intern for summer 2025. This full time position works for approximately 37.5 hours per week. The program will provide ... opportunities interns to understand the drug development, learn about statistical applications in clinical trials,...their further professional and career development. At the same time of their training exercise, the intern students can… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …domestic and foreign regulatory requirement but may seek support on such items from time to time .Has sufficient knowledge to identify critical issues or problems ... and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross...discussions to identify risks and ongoing study support.Ensures on time site shipments for subject and patient dosing, and… more
- Genmab (Plainsboro, NJ)
- …innovation.This is a hybrid role that requires being onsite 60% of the time in Princeton, NJ.ResponsibilitiesBuilds, leads and oversees the productivity of the US ... role within the pharmaceutical or biotechnology industry.Deep knowledge of drug development and a strong track record of success...experience is a plus.Willingness to travel 25-30% of the time , both global & domestic.For US based candidates, the… more
- Merck & Co. (Rahway, NJ)
- …of generating early clinical development plan and Investigational New Drug applications.Developing of clinical development strategies for investigational or marketed ... to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… more
- Aequor (MA)
- …Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical ... auditors, and consultants. Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive… more
- Merck & Co. (Rahway, NJ)
- …of generating early clinical development plan and Investigational new drug applications Developing clinical development strategies for investigational or marketed ... decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and Participating...and Travel on company business about 20% of the time to manage future or ongoing clinical research projects.… more
- Merck & Co. (Rahway, NJ)
- …(eg, GCP and ICH)Manage multiple competing priorities with good planning, time management and prioritization skillsAdvanced analytical skills with the ability to ... and presentation skills.Education/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceOR Master's… more
- Aequor (Waltham, MA)
- …auditors, and consultants. Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive ... and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use… more
- BioAgilytix (San Diego, CA)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... a strong focus on supporting a CRO, CMO, or drug development organization. Working knowledge of selling GMP CMC...Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid… more
- Legend Biotech USA, Inc. (Raleigh, NC)
- …in a timely manner, submitting expenses, etc.Reports adverse events to Legend's Drug Safety department and other internal departments as appropriate per required ... driver's license.Agility in multi-tasking.Able to travel 75% of the time .Proven track record of attaining organizational objectives.Exceptional organizational and … more
- Aequor (Thousand Oaks, CA)
- 100% remote Can sit anywhere in the US - any time zone Shift/Schedule: 8 5 pm, Monday - Friday Ideal Candidate: Leading the team, comfortable reaching out to people. ... if the focus is on API, or Formulation and Drug Product manufacturing experience if the focus is on...Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will help drive improvements in the Release to Promise turnaround time commitment to our patients and treatment centers, coordinate among key stakeholders ... Responsibilities Oversee the efficient and timely release of patient-specific, finished drug product batches by collaborating with all functions (including Quality… more
- Merck & Co. (North Wales, PA)
- …GCP and ICH)Ability to manage multiple competing priorities with good planning, time management and prioritization skillsStrong analytical skills with the ability to ... skills Education/Experience Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceOR Master's… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- ... and autoinjector assembly. This team produces clinical and development drug product batches in a GMP piloting facility supporting...will start on days for an initial period of time for training and onboarding before the team flips… more
