Associate

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives, and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization.

Roles & Responsibilities

1. To monitor the compliance with the requirements of Good Manufacturing Practice.
2. To ensure the instructions relating to production operations are strictly followed.
3. To update the real time data entry in BMR's, CKL, LS, ECC and other documents in DSP2.
4. To execute equipment qualification protocols and validation protocols.
5. To perform and document operations in accordance with cGMP.
6. Maintenance of Production equipment in coordination with maintenance department.
7. To comply with EHS policies and procedures.
8. Responsible for OTIF execution of all the activities related to Downstream Purification-2.
9. Data owner for process equipment used in day-to-day activity.
10. To gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.
11. Employee who are involved in GMP activities should undergo mandatory cGMP Training.
12. Frequency of mandatory training is once in a year.
13. All employees that involving with GxP environment should undergo a mandatory basic microbiology training.
14. To provides information guidance and recommendations to facilitate compliance with DI, GDP in documentation.
15. To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).

Required Skills & Competencies

• Bachelor's degree in biotechnology, Chemical Engineering, or equivalent field.
• 1 - 4 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations

Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.