|About the Job
Hi-Tech Pharmacal is a speciality pharmaceutical company that develops, manufactures and markets generic and branded prescription and OTC products. We specialize in difficult to manufacture liquid and semi solid dosage forms and offer a wide range of sterile opthamalic, otic and inhalation products.
We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work and diversity. Our competitve compensation and benefit programs reflect Hi-Tech Pharmacal's high regard for our employees. We are currently seeking an experienced Senior Formulation Scientist to work in our Research and Development Department.
Design and execute formulation experiments for sterile dosage forms such as ophthalmic suspensions, ointments, etc.
Coordinate sterilzation validation of equipment, components, actives, filter validation studies, etc. as per the requirements of aseptic processing of new products.
Develop manufacturing process for R&D formulations so that the technical transfer to sterile production area is successful.
Coordinate sourcing of API's, excipients, packaging components for new products to meet regulatory requirements.
Write master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocol/reports, Product Development reports, etc.
Prepare specification for drug products and packaging components, etc.
Coordinate the manufacturing of exhibit/submission batches per regulatory requirements.
Perform technology transfer for manufacturing processes from laboratory scale to the production scale
Provide technical support during process validation and cleaning validation studies
Coordinate with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA.
Assure that all formulation and process development activities are documented as per cGLPs.
Education and Skills:
MS/Ph.D in Pharmaceutical Sciences or related field with 4 - 10 years of experience in generic pharmaceutical environment. Experience in development of sterile products is essential.
Hands on experience in formulating ophthalmic dosage forms is a must.
Hands on experience in manufacturing of scale-up batches for liquid, semi-solids, sterile dosage forms, etc is essential.
A sound knowledge of regulatory requirements for product development and cGMP's is necessary.
Should have excellent planning, project management, verbal and written skills.
|Hi Tech Pharmacal|
State or Province