Job Description

Executive, Biopharmaceutical Operations

Job Location: Bengaluru, India

Reporting to: Assisstant Manager, Biopharmaceutical Operations

Job Grade: 9

Operating Unit : Biopharmaceutical

Department: Biopharmaceutical Operations

The Company

Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene\'s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

The Role

Purpose of this role is responsible to execute fundamental unit operations in Upstream manufacturing related to the manufacturing of bulk drug substance in the Microbial facility.

Key Result Areas

Role-specific:

• Execution of fundamental tasks CIP,SIP of Manufacturing process Equipments, media, buffer preparation vessels and close monitoring of batch performance data.
• Planning of Raw materials/consumables management for Manufacturing Campaign.
• Coordination with Cross functional departments for the activities like preventive, breakdown, maintenance, sample submission ,raw material & consumables readiness ,closure of documentation.
• Documents work according to cGMP and cGDP, adhere to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in timely and accurate manner, maintain facility areas according to predefined standards like SOPs,EOPs, Contribute to investigations and area Walk-throughs.
• Adheres to Syngene safety standards and identifies unsafe situations/habits and escalates appropriately.
• Perform Upstream activities under limited supervision and according to standard operating and manufacturing procedures.

Education and Experience

Education

M.Sc

Experience

3-6 years

Functional or Technical skills Required

• Expertise in upstream Unit operations (E.coli & Yeast), hands on experience in microbial process at manufacturing scale through automated SS fermenters and associated controls.
• Exposure to handle Bio-similar proteins handling in cGMP area, sound knowledge and awareness of GMP controls, Quality standards and regulatory aspects.
• Good in Quality Management systems & risk assessment tools.
• Experience in Equipment Qualification and commission aspects

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.

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Syngene International