- ThermoFisher Scientific (Boston, MA)
- …of the role. **Knowledge, Skills and Abilities:** **Must Have** + Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concepts + ... individual career goals while taking science a step beyond through research , development and delivery of life-changing therapies. With clinical trials conducted… more
- Lilly (Boston, MA)
- …next leader in cardiovascular and renal diseases. We are looking for a clinical research scientist (CRS) to provide clinical development support to a rapidly ... experience in Health-related field with 10+ years' industry experience + Clinical Research Scientist experience + Ability to **travel domestically and… more
- ThermoFisher Scientific (Boston, MA)
- …Demonstrated experience in developing and designing method transfer and validation studies per ICH and FDA guidelines is highly desired. + Prior experience with ... individual career goals while taking science a step beyond through research , development and delivery of life-changing therapies. With clinical trials conducted… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in drug products and drug substances, design studies according to the ICH guidelines to quantitatively evaluate the linearity, intermediate and repeatability ... the following job opportunity: **JOB LOCATION:** Lexington, MA **POSITION** : Scientist **POSITION DESCRIPTION** : Takeda Development Center Americas, Inc. is… more
- ThermoFisher Scientific (Boston, MA)
- …(LIMS, CDS, ELN) required. + Full understanding of laboratory requirements, client SOPs, ICH guidelines , USP requirements and FDA guidance + Proven problem ... individual career goals while taking science a step beyond through research , development and delivery of life-changing therapies. With clinical trials conducted… more
- ThermoFisher Scientific (Devens, MA)
- …Abilities:** + Knowledge of applicable regulatory authority, compendia, and ICH guidelines + Have experience in pharmaceutical research and development or in ... coat, ear plugs etc.) **Job Description** Thermo Fisher's clinical research business is a leading global contract research...knowledge, skills, and abilities to perform the job: + Scientist : With a bachelor's degree comparable to 2+ years… more
- ThermoFisher Scientific (Boston, MA)
- …is a plus + Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines , USP requirements and FDA guidance + Ability to utilize Microsoft ... Manufacturing Practices (GMP) Safety Standards **Job Description** Thermo Fisher's clinical research business is a leading global contract research organization… more
- Pfizer (Cambridge, MA)
- …Drug Development especially in Early Development + Strong knowledge of clinical procedures, ICH guidelines , GCP and familiarity with FDA, EMA, and global ... (OESD) is represented as need within clinical study teams (eg Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).… more
- Cambrex High Point (Waltham, MA)
- …and tech transfer of peptide APIs. + Strong understanding of regulatory guidelines ( ICH Q8/Q9/Q11, FDA/EMA expectations) and process validation. + Familiarity ... intensification technologies. Our company is catalyzing the transformation of research , development, and manufacturing across the pharmaceutical and fine chemical… more
- Sumitomo Pharma (Boston, MA)
- …strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ ICH safety guidelines for investigational and marketed products. The base ... diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research , and development to bring novel therapies to patients sooner. For more… more