4 Technical Transfer Jobs

You will be responsible for the development of new products and optimization of existing formulas across different product lines such as solid dosage products (tablets, capsules) and other delivery forms (liquids, powders) for regulated markets including the US, Europe, and ROW. Your tasks will involve formulation and process development of oral dosage forms, troubleshooting unresolved formula issues, designing formulation trials, and evaluating stability data to finalize composition. Additionally, you will develop manufacturing processes for R&D formulations to ensure successful technical transfer for large-scale batches. In this role, you will write and review various documents such as master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, and QOS. Collaboration with other departments like Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, and Inventory Control will be essential to expedite the development and approval of new products by the FDA. Practical experience in development, technology transfer, and ANDA submissions for solid/liquid oral dosage forms (solutions, suspensions, tablets, capsules) for regulated and semi-regulated markets like the US, Europe, and ROW is a key requirement. The ideal candidate for this position should hold a minimum Master's Degree in Pharmaceutical Sciences and possess at least 1 year of relevant experience.,

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products to serve underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline by leveraging integrated capabilities and a vast partner network. The company's patient-centric offerings span various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a team of talented individuals committed to enhancing patient lives through a combination of cutting-edge science and unwavering dedication to quality. The company values highly motivated individuals with integrity, dedication, and creativity to thrive within its organization. The Technical Operations department at Azurity is responsible for overseeing technical process strategy, managing contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), and delivering product objectives in line with company policies and client requirements. This role involves leading teams, collaborating cross-functionally, and achieving project milestones to support process scale-ups, validation, technical transfers, post-approval changes, and investigations for commercial products. **Principal Responsibilities:** - Manage the planning and execution of manufacturing activities, including qualification and validation for both development and commercial products. - Coordinate with contract facilities to review, approve, and execute controlled documentation related to late-stage development, qualification, validation, and manufacturing activities. - Direct tasks associated with late-stage product/process development, product transfers, equipment qualifications, and validation to ensure alignment with company objectives. - Support or lead product launch and commercialization efforts. - Establish and maintain policies, SOPs, and documentation to support validation practices per regulatory requirements and industry guidance. - Assist in Management Review and Compliance activities, preparing metrics and summaries for senior management communication. - Support Due Diligence activities related to product development, technical transfer, manufacturing, and commercial launch. - Collaborate with cross-functional team members from Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs. **Qualifications And Education Requirements:** - Bachelor's degree in Life Sciences (Master's degree preferred) or related field. - Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry. - Expertise in cGMPs, ICH, and Validation related requirements. - Proficiency in technical transfer of multiple dosage forms, various validation disciplines, and regulatory agency inspections. - Ability to work strategically, tactically, and hands-on. - Proficient in Microsoft Word, Excel, and Powerpoint. By applying for this role, you confirm your capability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may impact your ability to perform the job, please inform HR in advance.,

Job Title: Head Formulation & Development (F&D) Department: R&D / Plant Operations Location: Noida Job Purpose: To lead the Formulation & Development (F&D) team for plant operations, driving innovation, efficiency, and compliance in the development of nutraceutical products. This role is responsible for new product development, process optimization, scale-up, and technical transfer from lab to commercial manufacturing. Key Responsibilities: Formulation & Product Development: Lead end-to-end product development for powders, tablets, capsules, gummies, and liquid nutraceuticals. Design and optimize formulations based on scientific research, market trends, and regulatory requirements. Collaborate with marketing and regulatory teams to align product concepts with market needs and compliance. Scale-Up & Technical Transfer: Oversee successful scale-up of lab-scale formulations to pilot and commercial-scale batches. Manage technology transfer from R&D to manufacturing, ensuring consistency and quality. Work closely with plant and QA/QC teams to ensure process validation and documentation. Innovation & Process Optimization: Identify new ingredients, delivery formats, and technologies to enhance product efficacy and differentiation. Optimize formulation processes to improve efficiency, cost, and stability. Lead troubleshooting for manufacturing issues related to formulation or process. Regulatory & Quality Compliance: Ensure formulations meet regulatory standards (FSSAI, AYUSH, USFDA, etc.). Maintain detailed documentation, including specifications, MBRs, SOPs, and technical dossiers. Support audits and product registrations as needed. Team Leadership & Collaboration: Manage and mentor the F&D team, fostering innovation and technical excellence. Liaise with procurement, production, quality, and marketing departments for cross-functional alignment. Build partnerships with external vendors, CROs, and research institutions. Qualifications & Experience: M.Pharm / M.Sc / PhD in Pharmaceutics, Food Science, Biotechnology, or related field. 10+ years of experience in formulation development within nutraceutical, pharmaceutical, or functional food sectors. Proven expertise in product development, tech transfer, and manufacturing scale-up. Strong knowledge of GMP, FSSAI, and international regulatory guidelines. Excellent leadership, problem-solving, and communication skills. Desirable Attributes: Passion for innovation in nutrition and wellness. Hands-on experience with sports nutrition and performance-based products. Familiarity with international market requirements (e.g., NSF, Informed Choice, etc.). Strategic thinking with attention to operational detail.

Key Responsibilities: Manage day-to-day operations of the pilot plant, including planning and execution of experimental batches. Collaborate with R&D and Process Engineering teams to develop, validate, and scale up new processes. Ensure compliance with safety standards, SOPs, and regulatory requirements. Oversee equipment maintenance, calibration, and readiness for trials. Supervise a team of technicians and operators, providing technical guidance and training. Analyze process data and prepare detailed technical reports on trial outcomes. Identify and resolve process-related issues during scale-up or optimization. Ensure proper documentation of experiments, deviations, and process improvements. Coordinate raw material and utility requirements for pilot batches. Drive continuous improvement initiatives related to productivity, safety, and cost-efficiency. Required Qualifications & Skills: B.E./B.Tech or M.E./M.Tech in Chemical Engineering. 812 years of experience in pilot plant operations in a chemical or API manufacturing environment. Strong understanding of chemical processes, scale-up principles, and process safety. Hands-on experience with distillation, crystallization, filtration, reaction operations, etc. Working knowledge of process instrumentation and automation is an advantage. Proficient in data analysis and technical reporting. Strong interpersonal and team leadership skills. Familiarity with HAZOP, PSSR, and other process safety tools is preferred.