We have been engaged to find a PhD-level Scientist for the Quality Control
Dept of our client biopharmaceutical company. Our client has therapeutics
and vaccines in the market and a strong pipeline of products in various
stages of development and clinical trials. This person will be responsible
for assay transfer, trouble-shooting of existing QC methods, stability and
LIMS. He/She will ensure the thorough training of staff, the performance
of assays and the overall support of QC testing. Other responsibilities
include: Insure all testing meets cGMP standards, Direct and perform
assay qualification and validation, Interact with R&D, Clinical,
Development, and Quality Control staff, and Work both at the bench and in
an administrative capacity.
A qualified candidate will be knowledgeable and proficient in the methods
necessary to develop and perform assays for QC. He or she must be
knowledgeable in stability programs and LIMS systems and must be familiar
with cGMP regulations and the QC process.
Major Duties and Responsibilities:
1. Oversee the following: Assay transfer in to QC and transfer to outside
laboratories. Implementation and use of LIMS. Troubleshoot existing assays.
2. Ensure that the stability program for commercial and Phase 3 products is
developed and followed.
3. Review of data produced by QC Dept.
4. Assure that deadlines as related to the department are met.
5. Interact with the other depts and outside contractors to insure that
their needs are met and properly communicated to other staff.
6. Oversee junior staff. Perform reviews and career development of junior
staff.
7. Insure testing meets both Company and cGMP guidelines.
Requirements/Qualifications:
Ph.D degree in biological or chemical science or equivalent experience and
must have five or more years postdoctoral experience in assay development
in the biotech field.
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 * USA *
(520) 203-0074 Office (520) 203-0075 FAX
E-mail: rathbun@sedona.net