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Home
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Jobs in palghar
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Pelltech Healthcare
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Senior Executive, R&D- Formulation & Development

Senior Executive, R&D- Formulation & Development

Pelltech Healthcare

5 - 8 years

7 - 10 Lacs

palghar

Posted:1 day ago| Platform:

Apply

Skills Required

process design data analysis process optimization pharmaceutics analytical pharma risk assessment packaging glp troubleshooting

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Summary:

We are looking for a highly competent and experienced

Senior Formulation & Development (F&D) Chemist

with

extensive hands-on exposure in the development of solid oral dosage forms

, specifically

tablets and pellets

. The candidate must possess in-depth knowledge of formulation strategies, process optimization, and regulatory documentation, with a

strong command over the preparation of Product Development Reports (PDRs)

in line with global regulatory expectations.

Key Responsibilities:

Formulation Development (Tablets & Pellets Focus):

Develop robust and scalable formulations for
immediate-release (IR), modified-release (MR), and delayed-release (DR) tablets
as well as
multi-particulate pellet formulations (coated or uncoated)
.
Conduct
pre-formulation studies
, API characterization, excipient screening, and compatibility studies.
Design and execute
lab-scale, exhibit, and validation batches
of tablets and pellets using QbD principles.
Optimize critical formulation and process parameters for
wet granulation, dry granulation, direct compression
, extrusion spheronization, layering, and
pellet coating
processes.
Conduct process optimization and scale-up in coordination with manufacturing or pilot plant teams.

PDR Preparation & Documentation:

Independently
prepare comprehensive and compliant Product Development Reports (PDRs)
, including:
Justification for formulation approach and component selection
Process design, optimization, and scalability strategy
Risk assessment (FMEA) and control strategy
Compatibility, stability, and in-process data interpretation
Troubleshooting and change justifications (if applicable)
Prepare supporting documentation such as
MFR, FPSs.
Ensure all documentation complies with
ICH, USFDA, EU, and other applicable regulatory
guidelines.

Regulatory & Quality Compliance:

Ensure all development and documentation activities are conducted in accordance with
cGMP
,
GLP
, and
global regulatory expectations
.
Collaborate with QA and Regulatory Affairs during internal and external audits, as well as during regulatory filings.
Contribute to dossier preparation by providing required CMC data and responding to technical queries.

Cross-Functional Collaboration:

Work closely with Analytical R&D, Packaging, QA, Regulatory, and Manufacturing departments to ensure project alignment and successful execution.
Support technology transfer to commercial production teams with detailed technical input and documentation.

Team Leadership & Mentoring:

Guide junior scientists and trainees in conducting formulation trials, data analysis, and documentation practices.
Train team members on best practices for tablets and pellets formulation and PDR preparation.

Qualifications & Experience:

Education:
M.Pharm (Pharmaceutics) or B.Pharm
Experience:
5 8 years in pharmaceutical F&D, with
specific hands-on experience in tablets and pellets formulation
Must-Have Skills:
Deep understanding of
granulation techniques
, compression, coating, and pelletization processes
Strong expertise in
scientific writing and PDR preparation
Experience in formulation development for
regulated markets (e.g. EU, ROW, Russia, Chille and other regulated Market)
Preferred:
Exposure to
QbD
and
regulatory filing

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