- SOFIE (Miami Lakes, FL)
- …adhering to SOFIE's quality management system and maintain a state of cGMP control at the site. Ensure aseptic operations follow internal procedures ... end-of-day reports and daily dose management reports. Perform the duties associated with synthesis, quality control , and quality assurance of FDG and NaF,… more
- Amgen SA (Thousand Oaks, CA)
- …PQL has responsibility for working with PQ staff and executive leadership, International Quality , Quality Control , Contract Manufacturing Quality , ... and regulatory requirements Knowledge of analytical techniques used for synthetic product quality control Understanding of drug substance and drug product… more
- SOFIE (Totowa, NJ)
- …on existing or new equipment. Collaborate with other production radiochemists and quality control chemists as required to ensure successful protocol development ... to reality-ensuring every process meets the highest standards of quality and regulatory compliance (21 CFR 211 and 212)....of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. o It is expected that the development… more
- Gilead Sciences, Inc. (Foster City, CA)
- … quality oversight for GMP activities within Analytical Development Operations and Quality Control at Gilead Foster City site, Contract Testing Laboratories, ... teams in a biotech or pharmaceutical development environment and strong knowledge of cGMP quality systems and have extensive experience in managing contract… more
- Vaisala (Boston, MA)
- …budgets and maintain calculations and related documentation. Perform and analyze quality control checks. Review calibration certificates for accuracy and ... Service Quality and Metrology Manager Location Boston, US Vaisala...and audits. Understanding of pharmaceutical requirements such as FDA, cGMP , USP, and MHRA. OSHA 10‑hour construction certification (required… more
- Cresilon, Inc (New York, NY)
- …and execute test methods to aid in exploratory research, product development, and quality control ; conduct chemical and mechanical property evaluation tests to ... disclosures. Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control...experience in new product research and development in a cGMP ‑regulated industry is required (work experience in the Medical… more
- Cresilon, Inc (New York, NY)
- …towards FDA/regulated authority submissions, Act as research liaison between R&D and Quality Control to define product specifications. Maintain active dialogue ... polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation… more
- Cresilon, Inc (New York, NY)
- …of testing methods to aid in exploratory research, product/process development, and quality control ; conduct chemical and mechanical property evaluation tests to ... product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that… more
- MSD Malaysia (Boston, MA)
- …protocol design.* Strong understanding of radiopharmaceutical development, radiochemistry, and quality control ; proven ability designing quantitative PET studies ... early-phase clinical trials (Phase I), ensuring robust study design and high- quality PET data collection.* **Regulatory support**: Familiarity with regulatory and … more
- Gilead Sciences, Inc. (Foster City, CA)
- … QC , validations, and transfers, life-cycle management Developing analytical control strategies for drug substance and drug product, ensuring patient-centric ... product. Additionally, they will be accountable for ensuring that product quality targets and specifications are established based on robust patient-centric… more
