Needs for Downstream Manufacturing (Cell Culture)- Executive

Job Description

Designation: TraineeJob Location: BangaloreDepartment: Biopharmaceutical OperationsAbout SyngeneIncorporated 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.Job PurposePurpose of this role is supervisor at downstream manufacturing process at Syngenes manufacturing facility for Cell culture products 100L,500L and 2KL scale respectivelyKey Responsibilities: Execution and Supervision of downstream manufacturing activities (Chromatography, filtration systems and preparation of downstream accessories).Manage the team and plan daily downstream execution activities.Active trouble shooting to minimize the various risks prior to execution and during execution.Planning of raw material /consumables management for production campaign.Maintenance of Operations equipment in coordination with Maintenance Department.Monitoring of process efficiencies.Reporting of non-conformities and implementation of corrective/preventive actions in specific areas of operation.Adherence to pollution control and safety requirements.Issue, Checking and Review of Operations documents.Meet training requirements.Preparation, revision and review of Batch Manufacturing Records.Preparation of general validation protocols and report, Performance qualification documents.Review of Quality Department Protocols related to Operations.Reporting Deviations and Change controls from Operations to QA.Investigation of Batch failures in Operations.Review of written Batch records, checklists and associated written documents in Operations.Preparation and review of Operations related documents.Process equipment commissioning & qualifications.Candidate should be ready to work in shifts.Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safetyAttend training on environment, health, and safety (EHS) measures imparted companyEducational Qualification: Master s Degree in Biotechnology/Biochemistry/Chemical EngineeringTechnical/functional Skills:Expertise in downstream unit operations.Strong Hands on experience with Chromatography and filtration.Exposure to handle of recombinant proteins and biotheraputics projects in cGMP area.Sound knowledge and awareness of GMP controls,Quality systems and regulatory aspects.Experience on the Equipment Qualification and commissioning aspectsExperience:FreshersBehavioral 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 while working on allotted responsibility.Equal 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 :
equal employment opportunityanimal health