Athena Drug Delivery Solutions
Website:
athenapharmaceutiques.com
Job details:
Job Summary
We are seeking an experienced Formulation Development Executive with a strong
background in Liquid Orals and Nasal dosage forms to join our R&D team. The ideal
candidate will have hands-on experience in developing formulations for regulated
markets such as the EU and Brazil (ANVISA), and will be responsible for driving product
development from concept through technology transfer, ensuring compliance with
applicable regulatory guidelines.
Key Responsibilities
• Design, develop, and optimize formulations for Liquid Oral and Nasal dosage
forms in line with target product profiles (TPP) and Quality Target Product Profiles
(QTPP).
• Conduct pre-formulation studies, including drug-excipient compatibility,
solubility, and stability assessments.
• Execute formulation trials at lab scale and scale-up batches, ensuring
reproducibility and robustness of the process.
• Prepare and review Batch Manufacturing Records (BMRs), development reports,
and technology transfer documents.
• Ensure formulations comply with EU (EMA) and Brazil (ANVISA) regulatory
requirements, including relevant guidelines on excipients, container closure
systems, and impurity profiles.
• Coordinate with Analytical Development (AR&D), Regulatory Affairs, Quality
Assurance, and Packaging Development teams for seamless product
development.
• Support technology transfer to manufacturing sites, including process validation
and scale-up activities.
• Handle stability studies (accelerated and long-term) as per ICH guidelines and
review stability data for regulatory submissions.
• Troubleshoot formulation and process-related issues during development and
manufacturing scale-up.
• Maintain proper documentation as per GLP/GMP and data integrity
requirements.
• Stay updated with regulatory guidelines, compendial requirements (USP/EP/BP),
and industry trends relevant to liquid orals and nasal products.
• Support preparation of regulatory dossiers (CTD/eCTD format) with technical
inputs for EU and Brazil submissions.
Required Qualifications & Skills
• Education: M.Pharm (Pharmaceutics or related field)
• Experience: Minimum 5 years of hands-on formulation development experience
in Liquid Orals and Nasal dosage forms, specifically for regulated markets (EU /
Brazil).
• Strong understanding of dosage form-specific challenges — preservative
efficacy (liquid orals), and device compatibility (nasal sprays/pumps).
• Working knowledge of regulatory requirements for EU (EMA) and Brazil (ANVISA)
markets.
• Good understanding of ICH stability guidelines, QbD principles, and risk
assessment tools (FMEA).
• Strong documentation, analytical thinking, and problem-solving skills.
• Good communication and cross-functional collaboration skills.
Click on Apply to know more.
