Title: Executive
JOB DESCRIPTION
Designation: Executive
Job Location: Bangalore
Job Grade: 9
The Company
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and 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 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
Key Result Areas
Role-specific:
- Active involvement in all upstream manufacturing activities.
- Perform error free operation by eliminating operational gaps in advance.
- Active trouble shooting to minimize the various risks prior to execution and during execution.
- Initiate and process upstream deviations /investigations and closure.
- Pre -execution activity: Area and equipment readiness.
- Issuance of raw material /consumables and issuance batch records.
- Upstream process execution: Batch process operation /unit operation (including CIP, SIP and preparation upstream accessories), close 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 EHS, cGMP and HRD.
- Ensure process equipment's/instruments are in Qualified in state.
- Verify PM, check the log books and ensure the clean room requirements in order to get line clearance from QA for batch execution.
- Active coordination with inter-depts. for sample submission, closure of documentation and timely execution and contribution for the assigned tasks.
- Perform on-line documentation, cGMP compliance in all the manufacturing activity, and timely closure of executed documents and batch records.
- Ensure the Quality system is followed in day today upstream operations. Identify the gaps in the system to improve.
- Active involvement in all upstream manufacturing activities.
- Perform error free operation by eliminating operational gaps in advance.
- Active trouble shooting to minimize the various risks prior to execution and during execution.
- Initiate and process upstream deviations /investigations and closure.
TECHNICAL /FUNCTIONAL SKILL:
- Expertise in Upstream unit operations (CHO based mammalian expression systems).
- Strong Hands on experience with SUB (Up to 2000 L scale)
- Exposure to handle of Bio-similar proteins and Mabs projects in cGMP area.
- Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects
- Experience on risk assessment tools and change management.
- Experience on the Equipment Qualification and commission aspects
Education and Experience
Education
Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.
Industry Experience
- Minimum 0-4 years of relevant practical experience in Upstream Manufacturing for biopharmaceuticals, specifically with CHO cell lines for monoclonal antibodies, fusion proteins, etc.
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.
Pls visit us at https://syngeneintl.com/ to know more about us and what we do.