Solid orals & Injectables (Technology Transfer) - Senior Executive

Cronus Pharma one among the top 5 largest in the world, is a fully integrated R&D, manufacturing, and marketing animal health pharmaceutical company headquartered in East Brunswick, NJ. Dedicated to providing quality and cost-effective pharmaceuticals to the U.S. animal health market, our companion, equine and production animal products are accessible to all veterinarians and pet owners through national and regional distributors. Our team of seasoned industry professionals have been intimately involved in the establishment, and growth of several pharmaceutical manufacturing, and distribution firms in both the animal health and human pharmaceutical industries.

Through our in-house R&D and licensing, Cronus brings several differentiated generic products serving the companion, equine and production animal markets.

We have a growing portfolio of 76 approved products of which 26 are currently marketed.

We are dedicated to investing in Research & Development and have an extensive team of scientists developing innovative products. Several products are under development as well as pending FDA approval.

Licensed in all 50 states to distribute pharmaceutical products, our products are accessible to all veterinarians and pet owners nationwide at national and regional distributors.

Our passionate team is committed to growing our business and being among the leading veterinary pharmaceutical companies in the country.

Novel approach to drug development: We are dedicated to investing in Research & Development and have an extensive team of scientists developing innovative products. Several products are under development as well as pending FDA approval. Generic drugs from Cronus are safe and effective products that have been approved by FDA after meeting all the stringent requirements on quality, efficacy and are bio equivalent to brand name drugs. Products are manufactured at our FDA approved facility and select CMOs adhereing to current Good Manufacturing Practices.

Job description

ü Dosage forms experience: Solid Oral & Injectable experience in TTD/PDL/MS&T.

ü Perform formulation development activities on differentiated formulations and innovative technologies as part of product development in R&D and in Pilot/Manufacturing Site.

ü Follow good laboratory practices, good documentation practices (LNB writing) and maintain the logbooks and forms for equipment/instruments.

v Dedicate Experience in technology transfer of product(s) under development activities from scale up, exhibit batches.

v To lead and support the site transfer products from scale up to product launch.

v To prepare, review and hand-over the Technology Transfer Dossier to plant and communicating effectively to CFT team :-

§ MFR, MPR, BMR, BPR,

§ Preliminary Risk assessment (as per QbD)

§ Risk Assessment of before going to Scaleup

§ Risk Assessment of before going to Exhibit batches

§ Scaleup Protocol & reports

§ Scaleup Sampling and Exhibit batch sampling Plan

§ Exhibit batch reports

§ Control Strategy (Qbd) before Scaleup, Exhibit batches

§ Risk assessment of CPP over CQAs and etc.

And not limited to.

v To provide the technical inputs for initiation of Scale up batches.

v To provide the technical presentation on new product initiation to Cross functional team.

v To monitoring and execution of Scale up batches for site transfer products as well as in-house developed products.

v To co-ordinate with cross functional teams for smooth technology transfer.

v To review the exhibit batch documents, intended documents for filing purpose.

Qualifications

• M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 4 to 9 years in technology transfer solid oral formulations and injectable products.

Skills Required
injectable , Risk Assessment