Role & responsibilities 1.Machinery Breakdown Management. 2. Operation and Preventive Maintenance. 3. SOP Preparation and Documentation. 4.Training and Development. 5.Equipment Qualifications. 6.Documentation and Data Management. 7.Material Coordination. Description: Attend or delegate personnel to attend machinery breakdowns promptly Monitor and verify the operation, preventive maintenance, and troubleshooting of process equipment. Responsible for qualifications (IQ, OQ, PQ), requalification, and revalidations of process equipment.
a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must.
Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.
Role & responsibilities Sourcing and procurement of APIs and their impurities, and developing new or alternative vendors. API indents and planning as per the monthly production or PD schedule, coordinating with the PPIC Team and Warehouse team. Conducting due diligence audits of API facilities. Coordinating with the Regulatory and Quality Teams to arrange responses from vendors for queries and investigations. Experience in making monthly purchase statements, generating purchase orders, and work orders, as well as generating purchase performance reports on a bimonthly basis. Evaluating CDMOs for the synthesis of new APIs. Sound knowledge in vendor qualification and 21 CFR compliance, as well as licenses related to API vendors. Hands-on experience in drafting and negotiating agreements with API vendors.
Job Responsibilities : Develop and validate IVIVC and PBPK models to predict in vivo drug performance from in vitro data. Conduct in vitro experiments such as solubility, dissolution, and permeability studies using biorelevant media. Collaborate with formulation, analytical, and clinical teams to optimize drug product development. Analyze bioequivalence (BE) study data and support regulatory submissions with modeling insights. Prepare and review technical reports, protocols, and regulatory documentation . Preferred candidate profile & Qualifications: Should be well versed with IVIVC concepts,preferably 5-10 years of experience. Should have excellent knowledge on product development and clinical studies. Should have hands on experience on operating various simulation tools necessary for IVIVC. Excellent communication skills are must. Strong knowledge of oral solid dosage forms (OSDs) and excipient functionality. Experience with regulatory guidelines (e.g., USFDA, EMA) related to IVIVC and BE studies. M.Pharm or Ph.D. in Pharmaceutics, Biopharmaceutics, or Pharmaceutical Sciences.
Role & responsibilities Product Strategy & Planning Define development strategy for injectable formulations (solutions, suspensions, emulsions, lyophilized products) Align product pipeline with regulatory and market needs (US/EU/ROW) Formulation & Process Development Lead pre-formulation studies, excipient compatibility, and prototype development Oversee scale-up, optimization, and validation of manufacturing processes Cross-Functional Leadership Collaborate with R&D, QA/QC, Regulatory Affairs, and Manufacturing teams Manage technology transfer to commercial sites or CROs Regulatory & Compliance Ensure documentation for ANDA/NDA submissions is complete and compliant Support audits and inspections with technical and regulatory expertise Project Management Develop timelines, allocate resources, and monitor progress across multiple projects Mitigate risks and troubleshoot formulation or analytical challenges Innovation & Market Intelligence Stay updated on novel delivery systems (e.g., liposomes, microspheres, depot injections) Benchmark competitors and identify opportunities for differentiation Preferred candidate profile Essential Skills & Competencies -Deep knowledge of injectable dosage forms, aseptic processing, and formulation science -Familiarity with FDA, EMA, ICH guidelines and dossier preparation -Ability to lead cross-functional teams and manage timelines effectively -Skilled in preparing MFRs, BMRs, SOPs, and handling change controls -Capacity to explore new technologies and delivery platforms -Strong verbal and written skills for internal coordination and external presentations -13-18 years of experience in pharmaceutical industry with expertise in injectables product development. -M.Pharma degree or equivalent qualification (e.g., Ph.D./Doctorate). -Proven track record of successfully leading complex projects from ideation to execution. -Strong understanding of global regulations governing pharmaceuticals (e.g., FDA, EMA).
Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.
Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.
Role & responsibilities 1. Sourcing and procurement of APIs and their impurities, and developing new or alternative vendors. 2. API indents and planning as per the monthly production or PD schedule, coordinating with the PPIC Team and Warehouse team. 3. Conducting due diligence audits of API facilities. 4. C oordinating with the Regulatory and Quality Teams to arrange responses from vendors for queries and investigations. 5. E xperience in making monthly purchase statements, generating purchase orders, and work orders, as well as generating purchase performance reports on a bimonthly basis. 6. Evaluating CDMOs for the synthesis of new APIs. 7. Sound knowledge in vendor qualification and 21 CFR compliance, as well as licenses related to API vendors. 8. Hands-on experience in drafting and negotiating agreements with API vendors.
Role & responsibilities Lead formulation strategy for new product development and lifecycle management. Drive end-to-end launch readiness: exhibit batches, scale-up, tech transfer, and validation. Collaborate with cross-functional teams (RA, QA, BD, SCM, PMO) to ensure launch timelines are met. Manage documentation for regulatory submissions (ANDA, CTD, etc.). Oversee equipment readiness, raw material planning, and pilot batch execution. Participate in project review meetings and provide technical updates to leadership. Identify risks and implement mitigation strategies during formulation and launch phases. Mentor and guide junior scientists and technical staff. Preferred candidate profile M.Pharm / M.Sc in Pharmaceutics or related field. 10-15 years of experience in formulation development and commercial launch. Strong knowledge of cGMP, ICH guidelines, and regulatory expectations (USFDA, EU, ROW). Proven experience in handling oral solid dosage forms (OSD), injectables, or complex generics. Excellent project management, communication, and leadership skills.
Role & responsibilities 1. Sourcing and procurement of APIs and their impurities, and developing new or alternative vendors. 2. API indents and planning as per the monthly production or PD schedule, coordinating with the PPIC Team and Warehouse team. 3. Conducting due diligence audits of API facilities. 4. Coordinating with the Regulatory and Quality Teams to arrange responses from vendors for queries and investigations. 5. Experience in making monthly purchase statements, generating purchase orders, and work orders, as well as generating purchase performance reports on a bimonthly basis. 6. Evaluating CDMOs for the synthesis of new APIs. 7.Deep understanding of vendor qualification, 21 CFR compliance, and licensing, ensuring regulatory alignment and sustainable development. 8.Hands-on experience in drafting and negotiating vendor agreements. Desired Skills: Any Post Graduate preferably from Pharmacy/Life Sciences Atleast 8 years experience in API sourcing role Interested candidates may send their updated CVs to: farzana.m@tiefenbacher.com
Role & responsibilities Position: General Manager- Product Development Laboratory (PDL) Location: AET Laboratories, Hyderabad, Telangana, India Reporting to: Managing Director & COO Role Overview AET Laboratories is seeking a visionary and results-driven leader to head its Product Development Laboratory (PDL). This strategic role involves leading pharmaceutical product development, driving innovation, ensuring regulatory compliance, and building a high-performance team to support the companys growth and global ambitions. Key Responsibilities Strategic Leadership & Innovation Define and lead the product development strategy, including patent landscape analysis and formulation methodologies. Drive innovation across all development projects, ensuring alignment with business goals and market needs. Lead technology scouting and adoption of advanced tools and techniques to enhance development capabilities. Operational Excellence Oversee departmental budgeting, infrastructure upgrades, system enhancements, and documentation processes. Ensure seamless technology transfer and robust training programs throughout the product lifecycle. Maintain the development laboratory at world-class quality and compliance standards. Project & Resource Management Manage all PDL activities, ensuring timely execution of projects within defined timelines and budgets. Monitor key milestones and proactively address risks to ensure successful project delivery. Allocate resources effectively based on project priorities and strategic objectives. Cross-functional Collaboration Partner with cross-functional teams including Analytical Development, Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing to ensure cohesive execution. Provide technical support and guidance to internal stakeholders and external partners. Talent Development & Team Building Lead recruitment, performance management, mentoring,and career development of the PD team. Foster a collaborative and innovative culture through on-the-job training and structured development programs. Implement Individual Development Plans (IDPs) to build a future-ready, high-performing team. Regulatory & Technical Oversight Ensure all formulations and processes are cost-effective, scalable, stable, and compliant with international regulatory standards. Review and approve technical documentation, including licensing and regulatory submissions. Collaborate with IVIVC and clinical teams to ensure timely and successful completion of bioequivalence studies. Reporting & Communication Provide regular updates to senior management on project progress, challenges, and strategic opportunities. Preferred candidate profile Qualifications & Experience M. Pharmacy (Pharmaceutics) and/or PhD preferred. Minimum 15 years of experience in pharmaceutical product development across solid oral, liquid, and sterile dosage forms. Proven leadership in managing innovative and differentiated product pipelines. Strong understanding of global regulatory frameworks and experience working with international clients. Excellent communication, documentation, and stakeholder management skills. Desired Skills Deep expertise in IVIVC concepts and clinical study design. Strong grasp of regulatory guidelines and pharmaceutical development fundamentals. Exceptional problem-solving, analytical thinking, and project management capabilities. Ability to inspire and lead high-performing scientific teams. Demonstrated courage, integrity, and passion in leading innovation with ethical and purpose-driven decision-making. Proven ability to cultivate a collaborative, curious, and improvement-focused team culture that embraces change and challenges convention. Strong commitment to advancing global health outcomes and driving sustainable pharmaceutical development initiatives. Interested candidates may send their updated CVs to: farzana.m@tiefenbacher.com