Formulation Scientist
3 weeks ago
**Job Title: Formulation Research and Development Scientist**
**Location**: Karkapatla
**Department**: Research and Development
**Reports To**:Plant Head
**Job Type**:Full-time
**Summary**:
We are seeking a dynamic Formulation Research and Development (FR&D)
Scientist to contribute to the advancement of our pharmaceutical products. The ideal
forms for global markets.
Key Responsibilities:
1. Formulation Development:
- Lead the development of solid oral dosage forms for the US, EU, and
ROW markets, ensuring compliance with regional regulatory
requirements.
- Utilize hands-on experience in RMG, Blender, Coaters and Fluid Bed
Processor (top and bottom spray) technologies to optimize formulation
processes.
2. QbD Concepts and Risk Management:
(QTPP), Critical Quality Attributes (CQA), Critical Material Attributes
(CMA), and Critical Process Parameters (CPP) for formulations.
- Identify risks associated with formulation and manufacturing processes,
implementing strategies for risk reduction and control.
**3. Technology Transfer**:
- Manage activities related to technology transfers, ensuring seamless
transition of processes between development and manufacturing teams.
- Prepare comprehensive technology transfer documents and execute
transfer protocols.
**4. Batch Execution and Compliance**:
- Execute exhibit and commercial batches, ensuring product consistency
and compliance with regulatory standards.
- Address deficiencies and inquiries from regulatory authorities, including
the FDA, WHO, Health Canada, and the EMA.
**5. Documentation and Reporting**:
- Maintain accurate and detailed laboratory notebooks in compliance
with company policies and regulatory requirements.
- Prepare comprehensive reports and documentation for internal and
external stakeholders.
**6. Collaboration and Communication**:
- Collaborate with cross-functional teams, presenting findings and insights in team meetings.
- Interact with regulatory agencies to address queries and facilitate
approvals.
**Qualifications**:
- Ph.D. in [Relevant Field] or equivalent experience.
- 2-4 years of experience in formulation research and development for solid oral dosage forms.
- Hands-on experience with RMG, Blenders, Coaters ,Fluid Bed Processor (top
and bottom spray), compression & encapsulation.
- Expertise in QbD concepts, risk management, and technology transfer.
- Proven track record of executing exhibit and commercial batches and
addressing regulatory deficiencies.
**Salary**: ₹20,000.00 - ₹40,000.00 per month
Schedule:
- Day shift
**Education**:
- Doctorate (preferred)
**Experience**:
- Formulation Research: 2 years (preferred)
- Research & development: 2 years (preferred)
- Encapsulation: 2 years (preferred)
Work Location: In person
**Speak with the employer**
+91 8520802095