Job Description

Junior Manager/Assistant Manager, Biopharmaceutical Operations

Job Location: Bengaluru, India

Reporting to: Deputy Manager, Biopharmaceutical Operations

Job Grade: 8

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 to perform downstream manufacturing process at Syngene\'s manufacturing facility for Cell culture products 100L,500L and 2KL scale respectively

Key Result Areas

Role-specific:

• 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
• Ability to work in a team and willingness to work in shifts including night shiftsPossess the knowledge and exposure to Environment, Health, Safety, and Sustainability (EHSS) practices.
• Follow Environment, Health, Safety, and Sustainability (EHSS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on Environment, Health, Safety, and Sustainability (EHSS)

Education and Experience

Education

Master\'s in Biotechnology

Experience

6-9 years

Functional or Technical skills Required

• 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 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