Regulatory Affairs Project Manager (Americas Region) sought by Fine Americas Inc. in Walnut Creek, CA to work with the Fine group management team to ensure that regulatory submissions/ authorizations are on track to meet the commercial priorities. Min req: requires a Bachelor of Science degree or foreign equivalent degree and 3 years experience in a similar multi-national agricultural or chemical company. Working knowledge of federal regulatory agencies in the Americas (EPA, PMRA, SAG, etc.), as well as California DPR, is a must-have. Also full functional knowledge of EU plant protection product regulatory requirements. Proven ability to manage complex project. Outstanding written/verbal communication skills, excellent interpersonal skills. Ability to interface with people at all levels effectively with internal and external customers at high level. Multi language skills strongly preferred. Up to 50% domestic and international travel. Must travel to the east coast to visit regulatory agencies in short notice. May require travel and/or relocation to various unanticipated locations throughout the U.S. Send resume to alisond@fine-americas.com. Ref# Regulatory Affairs Project Manager (Americas Region).

Principal Pharmacokineticists. Evaluate novel small molecules, drug linkers, & therapeutic proteins. Reqs: PhD* in chemistry, biology, pharmaceutical sciences, or rel fld or for deg equiv & 6 yrs exp. *In lieu of PhD, will accept Master’s degree in chemistry, biology, pharmaceutical sciences, or a related field or foreign degree equivalent and 4 years of experience. FT position with Seattle Genetics, Inc. in South San Francisco, CA. Send resumes to: Seattle Genetics, Inc., Attn: Kelly Lane, 21823 30th Drive SE, Bothell, WA 98021

Horizon Therapeutics USA Inc. Seeks a Director, Analytical Chemistry in South San Francisco, CA to provide strategic leadership, technical expertise, and specialized knowledge in analytical method development for release and stability testing of drug substances, raw materials, intermediates, and drug product. Oversee analytical activities at CMOS and contracting testing laboratories (CTOS), including the review and approval of test records, forms, methods, protocols and reports for development products. Prepare and deliver technical reports, documents, batch analyses, analytical methods, reference standard, etc. for regulatory submissions. Set up and perform experiments in the laboratory in support of pre-formulation, analytical method development, manufacturing process development, and troubleshooting. Expert in theory and handling of HPLC, GC, LCMS, GCMS serves as SME for areas of responsibility during regulatory inspections. Keep up to date with regulatory requirements including those of the FDA and various international regulatory governmental bodies. Direct, train, and supervise the development chemists and analytical scientists' work. Travel required 20% of the time to Horizon Therapeutics USA, Inc’s U.S. and Europe offices. To apply ref. Job# 0656861 & send resume to talent@horizonpharma.com.

Thermo Fisher Scientific Inc., seeks a Sr. Staff Scientist, Bioinformatics in South San Francisco, CA willing to travel nationally up to 10% of the time to develop and validate software algorithms and tools to support various applications (Oncology, Immuno Oncology, Reproseq, CarrierSeq). MS + 5 yrs. of exp. See full req’s & apply online: http://careersat.thermofisher.com. Req#11851BR.

Technical Regulatory Business Analyst for Genentech Inc., South San Francisco, CA. Support dvpt, delivery+ maintenance of tech. projects/ systems in pharma regulatory dept. Req: Master's in Mgmnt Info Sys, Comp Sci, Biotech, Pharma Sci, or rltd + 1 yr exp. Apply: http://applygene.com/202003-108234 (Job ID: 202003-108234)