Senior Research Associate

Business: PPL Digwal

Department: PTS

Location: Digwal

Job Overview: To perform AR&D actives as per GMP & Safety

Travel Requirements: NA

Reporting Structure:

Reports to Research Scientist - AR&D (Service)

Key Stakeholders:

Internal: QC, QA, SCM & Safety

External: NA

Experience:

• 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements.

Responsibilities for Internal Candidates

Key Roles & Responsibilities

1. Capable to handle independent projects

2. Analytical testing support to PDG synthetic group.

3. Coordinate with QA regarding method transfer, CCF and investigation reports.

4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments.

5. API Stability knowledge.

6. Capable to handle analytical method development, Implementation, Validation as per requirement.

7. Should have experience of Analytical method transfer to QC.

8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc.

9. Should aware about GLP practices and 21 CFR part-11.

10. Keep the work area clean and the laboratory under controlled temperature.

11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs.

12. Understand the safety and environmental aspect.

13. Maintain the reagents and standardize the volumetric solutions as per schedule.

14. Maintain the laboratory journals and instrument log books online.

15. Ensure compliance to Hazardous waste and chemical management.

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.