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37 Intas Pharmaceuticals Jobs

PDL OSD (Executive)

1-5 years

₹ 2.75 - 7L/yr (AmbitionBox estimate)

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This is an estimate of the average salary range for this position. It has not been reviewed by the company, and the actual salary may differ.

Ahmedabad

1 vacancy

PDL OSD (Executive)

Intas Pharmaceuticals

posted 1d ago

Job Description

Work Experience

The Product Development Leader (PDL) for Oral Solid Dosage (OSD) will play a pivotal role in leading the development of oral solid dosage forms (tablets, capsules, etc.) from early-stage formulation to commercialization. This position requires strong leadership in overseeing product development strategies, managing cross-functional teams, ensuring timely project execution, and ensuring compliance with regulatory requirements. The PDL will work closely with various internal departments such as formulation development, analytical services, regulatory affairs, and manufacturing.

Role & Responsibilities:

Formulation Development and Optimization:

Lead the formulation development for OSD products, including immediate-release, sustained-release, and controlled-release formulations.

Design, develop, and optimize drug formulations based on pre-formulation studies, physicochemical properties, and therapeutic needs.

Troubleshoot formulation issues and implement innovative solutions to improve product quality and performance.

Project Leadership and Management:

Manage product development projects, ensuring adherence to timelines, budgets, and resources.

Provide technical guidance and oversight to formulation development teams.

Lead cross-functional teams to drive development from laboratory scale to pilot and commercial scale.

Monitor and report on project progress, adjusting plans as needed to meet milestones.

Regulatory Compliance:

Ensure formulations and development processes comply with regulatory requirements (e.g., FDA, EMA, ICH, GMP).

Prepare and review technical documentation, including IND, NDA submissions, stability studies, and other regulatory documents.

Interface with regulatory bodies as required and support the preparation of regulatory filings.

Technology Transfer:

Oversee technology transfer activities from R&D to manufacturing, ensuring smooth transition and scale-up.

Work closely with manufacturing teams to resolve technical issues and ensure consistency during scale-up.

Collaboration & Cross-functional Interaction:

Collaborate with analytical development teams to establish appropriate testing methods and specifications.

Work closely with quality assurance and manufacturing to ensure compliance with SOPs and GMP standards.

Collaborate with clinical and regulatory teams to develop and submit data for clinical trials and regulatory filings.

Innovation and Process Improvement:

Stay current with industry trends, emerging technologies, and best practices related to OSD formulations and NDDS.

Identify opportunities for process improvements, cost reductions, and product innovation.

Stability & Product Performance:

Oversee stability studies and product performance evaluation to determine shelf-life, formulation stability, and product quality. Analyse and interpret data from stability studies and recommend formulation adjustments as needed.

Desired Experience & Expertise:

At least 1-5 years of experience in product development, with a focus on oral solid dosage (OSD) forms.

Strong knowledge of formulation development techniques, including granulation, compression, coating, and packaging.

Experience with advanced drug delivery systems (NDDS) is a plus.

Demonstrated experience in project management, regulatory submissions, and technology transfer.

Key Skills:

Strong understanding of pharmaceutical formulation, pre-formulation studies, and drug delivery systems.

Expertise in developing controlled release, extended release, and immediate-release formulations.

In-depth knowledge of ICH, GMP, and regulatory guidelines.

Qualification : M. Pharm with relevant function experience


Employment Type: Full Time, Permanent

Read full job description

Intas Pharmaceuticals Interview Questions & Tips

Prepare for Intas Pharmaceuticals Executive roles with real interview advice

Top Intas Pharmaceuticals Executive Interview Questions

Q1. How to use excell and basics of advance excellent
Q2. Generally Which type of glass use is pharmaceutical industries for parenteral packing????
Q3. What are trablashooting and system suitability? System suitability to check the system parofmence and analysis performance, trablashooting t ... read more
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What people at Intas Pharmaceuticals are saying

3.9
 Rating based on 233 Executive reviews

Likes

No work life balance salary also pay lesser then you work done

Dislikes

Food is too bad, tea is like hot water with sugar management is messed up, security person have more power the manager.

  • Salary - Poor
  • +4 more
Read 233 Executive reviews

Executive salary at Intas Pharmaceuticals

reported by 1.5k employees with 1-13 years exp.
₹2.3 L/yr - ₹9.6 L/yr
37% more than the average Executive Salary in India
View more details

What Intas Pharmaceuticals employees are saying about work life

based on 3.4k employees
50%
60%
47%
95%
Flexible timing
Monday to Saturday
No travel
Day Shift
View more insights

Intas Pharmaceuticals Benefits

Submitted by Company
Free Transport
Job Training
Soft Skill Training
Health Insurance
Submitted by Employees
Health Insurance
Free Transport
Job Training
Soft Skill Training
Cafeteria
Team Outings +6 more
View more benefits

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Intas Pharmaceuticals Ahmedabad Office Location

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Ahmedabad, Gujarat Office
Headquarter
Intas Pharmaceuticals Ltd. Corporate House, Near Sola Bridge, S. G. Highway, Thaltej, Ahmedabad – 380054. Gujarat. India. Ahmedabad, Gujarat
380054

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