Reference: #1064: We are seeking a Ph.D senior level scientist/manager to become the head of our biopharm client company's Stability Dept. He/She will have the primary responsibility to manage the GMP compliant stability program to support Phase I/II clinical testing. This will entail designing stability protocols for pre-clinical formulation studies and monitoring stability of clinical materials.
Principle Duties:
a.. Manage a GMP compliant stability program to support Phase I/II clinical testing.
b.. Design stability protocols for pre-clinical formulation studies and monitor stability of clinical materials.
c.. Responsible for summarizing stability data and writing reports for regulatory submissions including INDs and BLAs.
d.. Document the protocols and coordinate the execution of the studies.
e.. Will compile stability data into an Access database to generate reports on product stability at any time.
f.. Oversee the internal auditing program for GMP compliance and issue compliance reports.
g.. Will assist with the design of validation studies and completion of batch production records.
h.. Will have multi-departmental responsibility for coordinating and tracking contract services.
Requirements:
a.. Ph.D. in Chemistry, Biochemistry, or related discipline, with at least 8 years of industry experience.
b.. Supervisory experience a plus.
c.. Good written and oral communication skills, and computer proficiency, including Access databases.
Our client has therapeutics and vaccines in the market and a strong pipeline of products in various stages of development and clinical trials.
If you have an interest in this or other opportunities, please email your resume as an attached file or mail/FAX your CV/resume to RS&A to the attention of Ann G. Rathbun, Managing Director. All correspondence is held in strict confidence.
Rathbun, Sapir & Associates
P.O. Box 2337
Sedona, AZ 86339-2337
(520) 203-0074 Tel
(520) 203-0075 FAX
rathbun@sedona.net EMail
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