Job posting - SAPA-NE

Location: Suzhou, China
o Lead multiple formulation/process/scale up development projects at various stages
for solid, or semisolid, or parental dosage forms.
o Perform literature/patent search for innovation product development and generic
product development in supporting of regulatory submissions of INDs, NDAs, and
ANDAs or patent filings.
o Apply Quality-by-Design (QbD) principles to product development.
o Review analytical data, draft GMP manufacturing batch records/protocols, and
product development reports.
o Lead manufacturing investigations as required.
o Prepare project updates to group and sponsor in a timely manner.
o Provide documents in eCTD format to support regulatory filing.
o Collaborate with team members (formulators, analytical chemists, quality
assurance and manufacturing technicians) to ensure assigned projects to meet
agreed timelines.
o Ph.D. in Pharmaceutics, Chemistry, Chemical Engineering (or closely related
scientific disciplines) with 2-6 years work experience; or MS degree in
Pharmaceutics with 5-10 years work experience.
o Hands on experience in Pharmaceutical product development and GMP
manufacturing preferably ANDA development and filing experience. Familiarity and
working knowledge of manufacturing processes and equipment set up, operation
and troubleshooting for various pharmaceutical dosage forms.
o Strong written and oral communication skills
o Good team player r to work with groups
o CRO experience would be a plus
Qualified candidates should forward their resume to Please
reference the job title in the subject line.
Frontage Laboratories, Inc.
700 Pennsylvania Drive
Exton, PA 19341
Tel 610.232.0100
Fax 610.232-0101