- Amgen (Cambridge, MA)
- …stability testing. + Familiarity with USP monographs and chapters, and ICH/ FDA guidance documents related to analytical method transfer and validation, impurities, ... mutagenic impurities, etc. + Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner. + Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage… more
- Cole-Parmer (Franklin, MA)
- …markets preferably in diagnostics & molecular control markets. + Understanding of FDA and international regulated markets and how such regulations impact product ... design, labeling, manufacture, and testing. + A high level of initiative, creativity, and work with little supervision. Ability to build strong executive and peer relationships. + Ability to travel up to 25%, including some international. + Willing to take… more
- Charles River Laboratories (Shrewsbury, MA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
- J&J Family of Companies (Danvers, MA)
- …internationally ~5% of the time. **Strongly Preferred Qualifications** : + Experience in FDA Class II and III medical devices preferred. + Experience in equipment ... and tooling design, fabrication, process development, and validation. + Hands on experience in prototyping in pilot manufacturing and rapid prototyping; basic machine shop equipment preferred + Experience in Solidworks 3D modeling, 2D drawing applying GD&T,… more
- Evolent (Boston, MA)
- …for Medicare & Medicaid Services (CMS), Food and Drug Administration ( FDA ), and various prior authorization lists, facilitating timely decision-making for clinical ... and business review teams. + Demonstrate strong analytical abilities, with a proven track record of deriving valuable insights from both quantitative and qualitative data. + Collaborate with internal teams to define, measure, and report key performance metrics… more
- Wolters Kluwer (Waltham, MA)
- …regulatory published drug information and policy data sources (CMS, FDA , etc.) covering drug control/compliance programs, covered programs (Medicare/Medicaid) and ... other government drug-related policy and program information. * Have an in-depth understanding of drug classification systems, drug packaging attributes, drug clinical attributes, pricing and reimbursement data, and regulatory classifications-and how these… more
- Children's Hospital Boston (Boston, MA)
- …as well as regulatory and accreditation standards (Joint Commission, DPH, FDA , CMS). + Maintains professional skills and knowledge through educational programming, ... conference attendance, and leadership in professional organizations. Qualifications: + Minimum of a Bachelor's degree in Nutrition & Dietetics or a closely related field is required; Master's degree preferred. + A minimum of four years of progressive… more
- Biomat USA, Inc. (Worcester, MA)
- …organizational and problem-solving abilities. Ability to understand and assess FDA regulations. Strong integrity and commitment to quality and compliance. ... Full command of mathematics. Legible handwriting. High level of proficiency with computers. Proficient in root cause analysis and corrective/preventative actions. Ability to balance multiple competing priorities. Strong time management abilities. Proven… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV. ... + Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). + Excellent communication, collaboration, and influencing skills. + Ability to work effectively in a fast-paced, virtual environment. **Travel… more
- Charles River Laboratories (Wilmington, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more