Require for the Assistant Manager - Upstream Manufacturing

Job Description

Designation: Assistant Manager Upstream Manufacturing Job Location: Bangalore Department: Biopharmaceutical OperationsAbout Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.Key Responsibilities: Batch planning in accordance with BMP4 plant occupancy matrix. Supervise micro batch schedule and shift planning for day-to-day activities. Represent upstream in internal PRM s and participate in technical discussions with MSAT and client. Supervise the upstream activity from inoculum preparation to transfer of harvest to downstream processing. Raise purchase requisition (PR) for capex items. GMP compliance in all the manufacturing activities and closure of executed documentation. Facilitate and monitor that deviations and CAPA are addressed right the first time and maintain required standards of manufacturing quality systems. Perform GEMBA and safety walks for function specific suites as well as common area of bmp4. Responsible for handling (receiving, tracking, and providing response) the IPQA observation sheets issued to manufacturing. Perform review of the upstream related master batch records and executed batch records. Perform review of protocols (study protocols, equipment qualification protocols etc.). Review the executed protocols and provide adequate support for timely closure of the same. Collaboratively work with MSAT team to provide input for improvement of products/process. Work with maintenance and engineering to troubleshoot process problems and identify solutions that reduce the equipment downtime in a cost-effective manner. Facilitate and monitor that the QUOTIF deliverables related to USP are fulfilled as per the defined timeline. Participate in SQDECC meetings and drive the assigned element. Audit readiness of facility Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted companyEducational Qualification: M. Sc BiotechnologyTechnical/functional Skills: Candidate shall plan and manage the work related to upstreamExperience: 8-12 years of experience in upstream manufacturing (microbial cell culture)Behavioral Skills: Should have the capability to work in a team and ability to handle demonstrate a good team spirit. While possessing a good ability to follow instruction should also demonstrate innovative in his/her approach, good communication skills Should be proactive on while working on allotted responsibilityEqual Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
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