Sr. Executive/Assistant Manager New Product Development

Getz Pharma; Karachi Division; On-site; PKR 1,800,000 - 3,200,000; Full time

Job summary

Getz Pharma in Karachi seeks a dedicated product development professional to evaluate, design, plan, and monitor new product development projects while optimizing formulation and process parameters. The role focuses on ensuring CQAs and regulatory requirements are met throughout development.

Responsibilities include reviewing development documentation, supporting registration and commercialization, and coordinating technology transfer from R&D to manufacturing for scalable, compliant production.

Qualifications

• 3–5 years of relevant experience in a reputable pharmaceutical company.
• Hands-on experience with product development, technology transfer and commercialization.
• Experience in handling regulatory and GMP related documents.

Responsibilities

• Design and develop pharmaceutical products in compliance with QTPP and regulatory requirements.
• Plan development strategies for formulation, process, packaging, and stability studies.
• Coordinate technology transfer activities from R&D to manufacturing for commercial production.
• Conduct feasibility assessments, literature reviews, and risk assessments for new projects.
• Ensure cGMP, ICH guidelines, pharmacopoeia, and internal quality systems are followed.
• Review and control development documentation to support product registration.
• Lead cross-functional teams to meet product development milestones.

Skills

Pharmaceutical development

QbD & Risk Assessment

Process development

Technology transfer

Regulatory compliance

cGMP knowledge

Education

Bachelor's/Master's in Pharmacy (Pharm-D, M. Pharm)

Job description

Evaluate, Design, Plan and monitor new product development projects to ensure timely achievement of product development milestones, while design and execute optimization of formulation composition, manufacturing process parameters, and critical quality attributes (CQAs). Also responsible for reviewing, maintaining, and controlling all product development documentation in compliance with regulatory requirements, and support all relevant activities of successful product registration and commercialization.

Job Responsibilities:

• Design and develop pharmaceutical products in compliance with Quality Target Product Profile (QTPP), regulatory requirements.
• Conduct product feasibility assessments, literature reviews, innovator product evaluations, and technical risk assessments for new product development projects
• Prepare and implement development strategies for formulation, process, packaging, and stability studies.
• Plan and execute pre-formulation, formulation optimization, process optimization, and scale-up activities.
• Perform root cause analysis for development challenges and implement corrective measures to achieve desired product quality attributes
• Coordinate technology transfer activities from R&D to manufacturing for commercial production.
• Ensure compliance with cGMP, ICH guidelines, Pharmacopoeia requirements, and internal quality systems during all development activities.
• Coordinate and support comprehensive project plans for new product development (NPD) activities from concept initiation through commercialization

Requirements:

• Master's or Bachelor's degree in Pharmacy (Pharm-D, M. Pharm)
• Understanding of pharmaceutical product development principles for dosage forms
• Understanding of Quality by Design (QbD), Risk Assessment, and Process Development concepts
• Knowledge of excipient functionality, API characteristics, compatibility studies, and formulation strategies.
• Knowledge of pharmaceutical manufacturing processes and understanding of scale-up principles and commercial manufacturing requirements.
• Thorough knowledge of relevant ICH Guidelines, cGMP requirements, FDA, EMA, WHO, and other international regulatory expectations and Pharmacopoeia requirements

Eligibility Criteria:

• 3-5 years of relevant experience in a reputable pharmaceutical company.
• Hands-on experience / knowledge of product development, technology transfer and commercialization of pharmaceutical products.
• Experience in handling regulatory and GMP related documents.