Upstream Cell Culture Manufacturing- Senior Executive Job in Syngene International

Designation: Upstream Cell Culture Manufacturing- Senior Executive

Job Location: Bangalore

Department: Biopharmaceutical Operations

About 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.

Job Purpose

To execute and Operate Upstream manufacturing batch activities. To operate Process equipment like Single use Bioreactor, mixing systems, Filtration systems, Stainless steel preparation vessels, Cleaning in place vessels etc.

Key Responsibilities:

Execute all upstream manufacturing activities in the 2KL cell culture facility with disposable bioreactors.

Execute batch in shake flask, Wave bioreactor, 100 L SUB, 500 L SUB and 2 KL SUB.

Planning of raw material /consumables management for production campaign.

Monitor batch process operation /unit operation (including CIP, SIP, media preparation, and upstream process accessories preparation)

Monitoring of batch performance and data.

Follow and practice on-line documentation all the time.

Follow cGMP practices during the manufacturing activity and operations associated activities with QA, QC and EAM.

Attend the training session of EHSS, cGMP and HRD.

Follow environment, health, and safety (EHS) requirements always in the workplace ensuring individual and lab/plant safety

Attend training on environment, health, and safety (EHS) measures imparted company

Educational Qualification:

Masters degree in Biotechnology

Technical/functional Skills:

Expertise in Upstream unit operations (CHO based mammalian expression systems).

Handle mAb process for multiple products.

Strong hands on experience with Single use bioreactor (up to 2000 L scale)

Exposure of handling Bio-similar proteins and mAb projects in cGMP area.

Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects.

Experience on the Equipment Qualification and commission aspects

Must have basic information related to safety compliance (usage of PPEs etc.)

Experience:

3-6 years post qualification

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 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.