Work as Assistant Scientist - FRD in Perrigo API India

Perrigo, headquartered in Ireland is One of the World’s leading Pharmaceuticals Manufacturers, a global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription (Rx) pharmaceuticals, nutritional products, and active pharmaceutical ingredients (API), as well as receives royalties from Multiple Sclerosis drug Tysabri®. Nearly 13,000 Perrigo employees around the world commit themselves each day to the important mission of making Quality Affordable Healthcare Products. Over 3,000 unique formulations with over 18,000 SKUs, 50 Billion Oral solid and liquid/cream doses every year.

Post: Assistant Scientist - FRD - Process Developmnet & Technoclogy Transfer

No.of Post: 01

Job Description
Development and commercialization of new or reformulated products designing and documenting formulations which meet the company’s First-to-File and First-to-Market strategy.
Conducts process development and scale-up of new oral dosage product (in partnership with Product Development scientists) to facilitate manufacture of pilot bio lots in the Product Development Pilot Plant.
Participate in the manufacture of Pilot GMP lots in the Pilot Plant. Acts as internal/external Subject Matter Expert (SME) for process related technical issues and provides technical support to Technical Operations, Manufacturing, Quality and to third party contractors.
Ensure compliance with current Drug Enforcement Administration (DEA), current Good Manufacturing Practices (cGMP),Perrigo policies and Quality Systems, and all applicable regulatory agencies. Manages, coaches and subordinate supervisor, pilot plant mechanics and technicians and product development technicians.

Candidate Profile
The candidate should have hand on experience & understanding of various process technologies like wet granulation with Rapid mixer Granulator & Fluid Bed Process, Dry Granulation with Roller compacter, Direct compression process, various milling and drying processes, Pelletization, Tablets coating (Film coating, Sugar coating, Enteric coating etc), Pellets coating with wourster process etc.
The candidate should have knowledge as well as application & data interpretation skills with respect to QBD,DOE, various ICH guidelines , stability study , related substances, Polymorphism, BA/BE study etc
Well versed with various quality documents (SOPs/SWI, Guidelines, specification, Installation, Qualification report & training etc)
Technology transfer documents preparation, review and implementation like Formula card, scale up report, Proces Optmization and Validation protocol, stability protocol, BMR, BPR etc
Good at interpersonal skills & communication.

Additional Information:
Experience: 6-8 years
Qualification: M.Pharm
Location: Ambernath
Industry Type: Process Development & Technology Transfer
Functional Area: FRD
End Date: 25^thJanuary, 2017