{"schemaVersion":"jobsearcher.job.v1","id":"5a6f18d6e1a36cd7fa8ff50e","url":"https://jobsearcher.com/jobs/5a6f18d6e1a36cd7fa8ff50e","canonicalUrl":"https://jobsearcher.com/jobs/5a6f18d6e1a36cd7fa8ff50e","title":"Director, Formulation Development (Job Code: FD)","description":"Lead drug product formulation development for generics as well as innovative\nLead all aspects of formulation development team at Primera including staff hiring and development, daily operation and compliance, budget and expense tracking, regulatory strategy, submission management and client interaction as well as team development\nProvide scientific and related regulatory expertise regarding formulation development ranging from generics reformulation, preclinical to clinical research phase as well as other late-phase formulation development NDA/ANDA/505b(2) to seek regulatory approval\nExercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results\nInteract closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements\nWrite and review relevant reports for ANDA/IND/NDA applications\nSupport business expansion with existing customers and broaden the customer basis by participating strategy development and business development activities (with respective business units)\n\nRequirements:\nPhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 years’ experience in pharmaceutical industries\n3+ year experience in leading generics reformulation especially modified/extended release dosage forms with demonstrated successful ANDA or 505b(2) filing\nInnovative small molecule formulation development with demonstrated successful IND or NDA application filing highly desirable\nExcellent communication skills (oral, written, presentation), strong project management, team management and demonstrated problem solving skills\nGood knowledge of cGMPs, ICH guidelines, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, EMA/FDA CMC guidance documents will be an advantage\nAbility to work in a fast-paced, dynamic, environment","company":"Primeraanalyticalsolutions","rawCompany":"primeraanalyticalsolutions","city":"Princeton","state":"NJ","isRemote":false,"isActive":false,"createdAt":"2026-08-12T13:27:49.367Z","occupations":[{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"},{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"},{"code":"29-1051.00","title":"Pharmacists","slug":"pharmacists"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Director, Formulation Development (Job Code: FD)","description":"Lead drug product formulation development for generics as well as innovative\nLead all aspects of formulation development team at Primera including staff hiring and development, daily operation and compliance, budget and expense tracking, regulatory strategy, submission management and client interaction as well as team development\nProvide scientific and related regulatory expertise regarding formulation development ranging from generics reformulation, preclinical to clinical research phase as well as other late-phase formulation development NDA/ANDA/505b(2) to seek regulatory approval\nExercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results\nInteract closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements\nWrite and review relevant reports for ANDA/IND/NDA applications\nSupport business expansion with existing customers and broaden the customer basis by participating strategy development and business development activities (with respective business units)\n\nRequirements:\nPhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 years’ experience in pharmaceutical industries\n3+ year experience in leading generics reformulation especially modified/extended release dosage forms with demonstrated successful ANDA or 505b(2) filing\nInnovative small molecule formulation development with demonstrated successful IND or NDA application filing highly desirable\nExcellent communication skills (oral, written, presentation), strong project management, team management and demonstrated problem solving skills\nGood knowledge of cGMPs, ICH guidelines, CMC authorization, regulatory audit and inspection experiences are preferred. Familiar with government regulations, EMA/FDA CMC guidance documents will be an advantage\nAbility to work in a fast-paced, dynamic, environment","datePosted":"2026-08-12T13:27:49.367Z","dateModified":"2026-08-12T13:27:49.367Z","hiringOrganization":{"@type":"Organization","name":"Primeraanalyticalsolutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Princeton","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"5a6f18d6e1a36cd7fa8ff50e"},"url":"https://jobsearcher.com/jobs/5a6f18d6e1a36cd7fa8ff50e"}}