- Merck & Co. (Rahway, NJ)
- …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 ... (separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities include, but are not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of ... Lead development and implementation of robust non-GMP characterization methods, using quality by design principles and with focus on comprehensive life-cycle… more
- Organon & Co. (Jersey City, NJ)
- …oversight thereof while ensuring the scientific and data integrity, rigor and quality thereof. The director may represent the Clinical Pharmacology function ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
- Catalent Pharma Solutions (Kansas City, MO)
- ** Director , Quality , BioAnalytical ** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to ... to resolve quality concerns as appropriate. The Quality Director is the business partner to...and QC and strategic responsibility as part of the Quality Leadership Team for BioAnalytical . Leadership of… more
- CSL Behring (Waltham, MA)
- …Participate in external due diligence and provide expert advice on bioanalytical and biomarker assays, data quality , regulatory expectations, clinic/submission ... a meaningful difference worldwide. Could you be our next Director Clinical Assay Strategy? The job is in our...high level expertise and leadership capacity in area of bioanalytical and biomarker assays to support nonclinical and clinical… more
- CSL Behring (Waltham, MA)
- …Participate in external due diligence and provide expert advice on bioanalytical and biomarker assays, data quality , regulatory expectations, clinic/submission ... three days a week. You will report to the Director of Clinical Assay. **Position Description Summary:** You will...level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical… more
- CSL Behring (Waltham, MA)
- …Participate in external due diligence and provide expert advice on bioanalytical and biomarker assays, data quality , regulatory expectations, clinic/submission ... three days a week. You will report to the Director of Clinical Assay. **Position Description Summary:** You will...and provide high level expertise in the area of bioanalytical and biomarker assays to support nonclinical and clinical… more
- Gilead Sciences, Inc. (Frederick, MD)
- …We are seeking a highly motivated individual to join us as an Associate Director , to lead Quality Control Analytical Tech Services group, reporting to the ... Senior Director , Quality Control in Frederick, MD. In...or pharmaceutical industry + Well versed and experienced in bioanalytical methods working under GMP conditions. + Deep experience… more
- CSL Behring (Waltham, MA)
- …hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. You will part of a specialized non-laboratory based team and ... expert advice on vaccine serology and biomarker assays , data quality , regulatory expectations, clinic/submission readiness and associated risks. Research and… more
- Lilly (Indianapolis, IN)
- …motivated scientist to join the Laboratory for Experimental Medicine (LEM) as Scientific Director . This role is a part of a multi-disciplinary group of scientists ... relationship with third-party organization including management of the vendor quality system agreement, master service agreement, periodic inspections/audits and… more
- Boehringer Ingelheim (Fulton, MO)
- …High Performance Liquid Chromatography, plasma and tissue sample preparation, bioanalytical method development and validation. Conducts residue analysis for ... products. Contributes to project and task force teams and functions as Study Director or Sponsor Representative for BIAH studies. Responsible for the generation and… more
- Charles River Laboratories (Shrewsbury, MA)
- …Maintain the scientific, safety, and regulatory compliance integrity of the entire bioanalytical process. o Provide hands on technical leadership to staff from ... we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science...years. We're committed to providing benefits that elevate your quality of life. Based on your position these may… more
- Lilly (Indianapolis, IN)
- …to solve complex technical challenges. + Develops and maintains a robust quality system and business processes for reference standards and stability programs. + ... with key stakeholders **Basic Qualifications:** + A Ph.D. in analytical chemistry, bioanalytical chemistry, or a related discipline with at least 10 years of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …all clinical biomarker assays with BST and ensure high scientific quality of target engagement/pharmacodynamics, prognostic and predictive biomarker data to drive ... efforts from academic institutions, competitor biopharmaceutical companies, and fee-for-service bioanalytical CROs for translational biomarker research. + Responsible for… more
- Merck (Rahway, NJ)
- …include, but are not limited to:** + Work closely with the group Director to shape and execute strategy for biological characterization in all stages of ... Lead development and implementation of robust non-GMP characterization methods, using quality by design principles and with focus on comprehensive life-cycle… more
- Merck (Rahway, NJ)
- …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 ... (separation-based and residuals) and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics… more
