Formulation And Development Manager

Job Title:

Senior Manager Formulation Development (Generic Finished Formulations)

Department:

Research & Development (R&D) Formulation Development

Reports To:

Head – Formulation Development / Vice President – R&D

Job Purpose:

To lead and manage the development of generic pharmaceutical finished dosage forms (oral solids, liquids, injectables, topical, etc.) from concept through scale-up, technology transfer, and regulatory submission. Responsible for ensuring robust, cost-effective, and regulatory-compliant formulations aligned with company strategy and market requirements.

Key Responsibilities:

• Formulation Development & Optimization

• Lead the design and development of generic formulations for multiple dosage forms.

• Ensure development of stable, bioequivalent, and patient-friendly products.

• Drive pre-formulation studies, excipient compatibility, and optimization of manufacturing processes.

• Regulatory & Compliance

• Oversee preparation of product development reports, QbD documents, and regulatory submission modules (CTD/ANDA dossiers).

• Ensure compliance with CDSCO, USFDA, EMA, Health Canada, ENVISA and other global regulatory requirements.

• Provide technical support during regulatory audits and queries.

• Technology Transfer & Scale-up

• Lead pilot scale and exhibit batch manufacturing.

• Oversee technology transfer to manufacturing sites and ensure successful scale-up.

• Collaborate with Production, QA, and QC for smooth handover of products.

• Team Leadership & Project Management

• Manage and mentor formulation scientists and technical staff.

• Allocate resources, monitor project timelines, and ensure delivery as per business goals.

• Foster cross-functional collaboration with Analytical R&D, RA, Supply Chain, and BD teams.

• Innovation & Cost Optimization

• Identify and evaluate novel excipients, technologies, and platforms for product differentiation.

• Drive cost-effective formulation strategies without compromising quality and compliance.
• Monitor market trends, competitor products, and technological advancements.

Key Skills & Competencies:

• Strong technical expertise in formulation science (solid oral dosage forms essential; additional knowledge of liquids, injectables preferred).
• Deep understanding of QbD, ICH guidelines, and global regulatory expectations.
• Proven experience in bioequivalence-oriented development.
• Strong leadership, people management, and project management skills.
• Excellent problem-solving, analytical, and decision-making abilities.
• Effective communication skills (written & verbal) for cross-functional and regulatory interactions.

Education & Experience:

• M.Pharm / Ph.D. in Pharmaceutics / Pharmaceutical Technology.
• Minimum 10–15 years of experience in formulation development of generic finished dosage forms.
• Hands-on experience in developing products for regulated markets (US, EU, Canada).
• Proven track record of successful ANDA/NDA/MA submissions and approvals.

Work Location:

Ahmedabad, Gujarat

Company Profile:

Alpine Pharma Research is a group company of Alpine Health in USA which is a licensed pharmaceutical distributor based in Secaucus, New Jersey, USA that serves independent pharmacies across the US. Alpine Health offers a full range of generics, OTC's, diabetic supplies, vials and pharmacy supplies.

Alpine Pharma Research in India is focused on developing high quality products for regulated and no-regulated healthcare markets including USA, India and ROW region. Based in Ahmedabad the company has its own manufacturing facility of medical plastics and is also developing OTC formulations for worldwide market. The company aims to have a portfolio of products that cater to pharmaceutical and healthcare industry across the globe.