Bluefish Pharmaceuticals

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.,

Bluefish is looking for profiles to fill the position of Senior Manager – Supply Chain, contributing to the accomplishment of the Supply Chain function objectives. The position will report to Head – Supply Chain. The role would be involved in the below mentioned areas: Manage Supply Chain day to day operations. (Run monthly MRP cycle, Master Production Schedule (MRP) and monthly S&OP and Review meeting ) Leading order management process – Ensure Pos are generated as per the demand and shared with suppliers, order confirmations are received from suppliers on the delivery timelines. Conduct weekly and adhoc supplier meetings together with respective planners and share Minutes of the Meeting. Follow-up with suppliers for timely manufacturing and delivery of orders and ensure suppliers meet delivery timelines as per contract. Cross functional collaboration for aws, deviation, root cause and CAPA management. Coordination with International EU marketing team on supply feasibility, critical products. Coordination with internal logistics team & manufacturers for dispatch planning. Escalations handling as a point of contact. Monthly KPI reporting. Reporting Suppliers monthly performance on their deliverables Price negotiation with suppliers for substantial Sales and Tender volumes Inventory management Supply Agreement and Supply Addendum management. Facilitating Re-packing activity for opportunity sales or country specific requirements Co-ordination with CFT on Second Sourcing & Bulk Strategies Coordination with MKS team for batch size fulfilment & MOQ issues. Following up for monthly Mfg & packing plan with suppliers. Share critical SKUs to suppliers and coordinate to expedite packing plan. Share forecast to supplier on monthly/quarterly basis to suppliers. Coordinating for packing materials inventory with supplier for SKUs where AW’s revisions are applicable along QA & manufacturers for effective utilization of existing packing material. Co-ordination with RA for nearing MA country to proceed on Launch activity. Plan for New molecules launch as per patent off timelines. Timely AW’s implementation to avoid packing material destruction cost. Escalation on delay in supply due print proof /AW’s changes implications to next level for action planning. Supplier performance monitoring DIFOT reporting and share to suppliers on quarterly basis to improve their performance. Monthly MIS reporting. Candidate Specifications Education and Experience Master’s Degree and Supply Chain related certification, with at least 15 years of relevant experience in the area of Supply Chain Excellent computer skills, including Word and Excel in a Microsoft Windows environment Excellent interpersonal skills Skills in database management and record keeping Skills & Abilities Requirements Must have thorough knowledge of systems, processes and procedures related to supply chain Must have good communication skills Safety of the workforce Personal development thru’ self-learning About Bluefish Pharmaceuticals: Founded in Sweden, with its long tradition of industrial entrepreneurship, Bluefish Pharmaceuticals has become one of the most progressive generics pharmaceuticals companies. At Bluefish, we strive to make quality medicines accessible to more people. We create value in the full pharmaceutical value chain from developing to manufacturing and successfully marketing generic pharmaceuticals and we take pride in doing this in an innovative, responsible and cost-efficient way.