This position will be responsible for overseeing all microbiological aspects
of in-process, bulk and drug product manufacturing and testing at multiple
contract sites as well as authoring the sterility assurance section of the
NDA. Review sterility, endotoxin, and bioburden testing, environmental
monitoring programs, and water testing programs. Develop protocols and
procedures for the establishment, maintenance, and stability of master and
working cell banks, and lab certification plans. Qualified candidates will
have a minimum 8 years relevant quality control management experience in
pharmaceuticals. Must have extensive experience in asceptic processing and
sterility assurance. International and domestic travel is a requirement
(15-25%).
Some of our outstanding benefits include: 100% vesting in our 401K plan,
choice of HMO/PPO medical plan, employee stock purchase program, dental,
life and disability insurance, tuition reimbursement, flexible spending
accounts and 3 weeks vacation. In addition, we have unique extras such as:
on-site massage therapy, free parking and public transportation, 11
holidays, 5 of which are floating holidays, EAP benefit focusing on work
life balance issues and frequent celebratory parties!
Please contact Eric at scientificresources.com
Scientific Resources Inc.
214 Garden Street
Needham, MA 02492
781-449-3004 fax
www.scientificresources.com