ISTA Pharmaceuticals is a specialty pharmaceutical company focused on the development and
commercialization of unique and uniquely improved ophthalmic products for serious conditions
of the eye.
ISTA has two approved products, IstalolTM (for the treatment of glaucoma) and Vitrase® (for
use as a 'spreading agent'). We launched IstalolTM in July 2004 and are currently launching
Vitrase®. We have two pending NDAs with the FDA: Vitrase® (for the treatment of vitreous
hemorrhage) and XibromTM (for the treatment of ocular inflammation, eye pain and photophobia
following cataract surgery). We have other prescription products under development, including
ecabet sodium, for the treatment of dry eye, and Caprogel® for the treatment of hyphema.
In order to further build our pipeline as a specialty pharmaceutical company, we expect to
acquire complementary products in ophthalmology, either already marketed or in late-stage
development. ISTA has been well financed, and our management team has extensive experience in
the development and commercialization of ophthalmic pharmaceuticals.
We are currently seeking a Biopharmaceutical Production / Pilot Lab Manager.
Overall Responsibility: Manages the scale-up and on-going operation of a small-scale
biopharmaceutical production facility.
Duties & Responsibilities:
1. Manages the installation and validation of biopharmaceutical manufacturing equipment.
2. Manages the technology transfer and validation of the manufacturing process for a
biopharmaceutical (protein) active ingredient.
3. Supervises two or three technicians in the on-going commercial manufacture of a protein
4. Ensures that the facility and processes are operated in a manner compliant with cGMPs.
Assists with writing of manufacturing procedures, validation protocols and reports. Acts as an
advisor to subordinates to meet schedules and/or resolve technical problems. Works with R&D, QC
and QA in resolution of manufacturing issues. As needed, works in other departments to assist
with scale-up or development of new products.
Bachelor's degree in one of the chemical or biological sciences (Biochemistry, Chemistry,
Chemical Engineering, Biology, or Molecular Biology)
Prior experience required in the supervision or management of a pharmaceutical or biological
manufacturing operation. This may involve GMP pilot production, GMP clinical production or GMP
commercial production. Prior experience working in a pharmaceutical R&D or QC laboratory is a
plus. Applicable experience could include oversight of protein purification operations or
pharmaceutical compounding and blending operations. Previous experience managing scale-up or
manufacturing projects is also a plus.
Knowledge & Abilities
• Thorough knowledge of cGMPs is required.
• Experience with large scale chromatography and filtration operations, while not required,
would be a plus.
Physical Demands and Work Environment
This is a light manufacturing work environment requiring frequent gowning and clean-room
No outside agencies will be used.