Senior Executive-Technology Transfer

As a Senior Executive Technology Transfer at Bluefish Pharmaceuticals, you will contribute to the Technology Transfer Department function objectives. Reporting to the Senior Manager-Formulation Development, your responsibilities will include executing technology transfer, site transfer, alternate vendor development, and troubleshooting activities for tablets, capsules, and pellets. You will evaluate technical queries, address issues faced during commercial batches, and ensure regulatory compliance. Key Responsibilities: - Execute technology transfer, site transfer, alternate vendor development, life cycle management, and troubleshooting activities for tablets, capsules, and pellets. - Evaluate technical queries such as batch sizes, alternative sources for API & raw materials, and transfer site suitability. - Address technical queries from manufacturers and support Contract Manufacturing Organizations (CMOs) in troubleshooting issues during commercial batches, feasibility trials, or analytical feasibilities. - Demonstrate prior experience in technology transfer of generic drug products for regulatory markets, preferably the EU. - Possess strong technical skills in technology transfer and troubleshooting. - Exhibit effective communication skills and willingness to travel. - Prepare system and quality-related Standard Operating Procedures (SOPs). - Have knowledge of quality requirements for site transfers, documentation, and analytical practices. - Understand tooling, change parts, and their approvals. - Conduct project requirement assessments for execution. - Adhere to in-house systems and procedures to ensure current Good Manufacturing Practices (cGMP) and regulatory compliance. Qualifications Required: - Master's degree in pharmacy (Pharmaceutics/Industrial pharmacy) with at least 6 years of experience in technology transfer activities for Regulatory markets, specifically for solid oral dosage forms. - Excellent computer skills, including proficiency in Microsoft Word and Excel in a Microsoft Windows environment. - Excellent interpersonal skills. - Good communication skills. - Focus on the safety of the workforce. - Commitment to personal development through self-learning.,