JOB DESCRIPTION Department : Quality Control Chemical Designation : Manager – Stability Reporting To : Head – Quality Control Educational Qualification : M. Pharma / M.Sc. (Chemistry/Pharmaceutical Sciences) Job Responsibilities 1.Responsible for preparation and review of Stability Study Protocols, Stability Study Reports, and Stability Summary Sheets for all products (General Injectables and OSD). 2 Responsible for initiation, monitoring, and timely execution of stability studies for registration batches, validation batches, and commercial batches as per ICH guidelines. 3 Responsible for managing stability chambers, their qualification, calibration, and monitoring as per regulatory and internal guidelines. 4 Responsible for monitoring pull-out schedules, analysis of stability samples, and ensuring timely reporting. 5 Responsible for statistical analysis, trending, and evaluation of stability data, including identification and investigation of Out of Trend (OOT) and Out of Specification (OOS) results. 6 Responsible for preparation, review, and approval of analytical reports for Finished Products, In-process materials, Raw Materials, Packaging Materials, Water and Steam (Condensate) samples, including stability samples. 7 Responsible for preparation, review, and execution of Analytical Method Transfers and Method Validations related to stability and routine testing. 8 Responsible for preparation and review of Standard Operating Procedures (SOPs), Analytical Test Data Sheets, General Test Procedures, Specifications, and Calibration Data Sheets. 9 Responsible for review and handling of laboratory incidents, Out of Calibration (OOC) reports, deviations, OOS, OOE, OOT events, Change Controls, and Corrective and Preventive Actions (CAPA). 10 Responsible for Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) implementation and compliance across the team. 11 Responsible for preparation/review of Qualification Reports/Protocols for instruments and equipment used in the QC Laboratory. 12 Responsible for preventive maintenance schedules, calibration schedules, and management of instruments, including handling of breakdowns. 13 Responsible for management of Working Standards, Reference Standards, and Impurity Standards, including procurement, qualification, issuance, and maintenance. 14 Responsible for allocation of work, supervision, and review of activities performed by the QC team members and ensuring section-wise coordination. 15 Responsible for providing GMP/SOP/Analytical training to QC personnel and ensuring compliance to safety practices within the QC department. 16 Responsible for acting as Section Head and taking charge in the absence of the QC Head to ensure continuity and compliance. 17 Responsible for executing and monitoring QC activities related to the General block and Oncology block (ADL, R&D) at BDR Pharmaceuticals International Pvt Ltd, Baska Site. 18 Responsible for self-training and tracking of training status for self and team members on all applicable SOPs and protocols. 19 Responsible for cross-functional communication with R&D, QA, Production, and Regulatory Affairs teams for new product stability requirements, troubleshooting, and regulatory submissions. 20 Additional responsibilities shall be assigned as per organizational requirements based on operational needs.

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Will be responsible for South and West sales and marketing products of Derma division and will be based at Bangalore HQ.

Job title: Manager ( Oligonucleotide Chemist /Peptide) Job Description: 1. Highly skilled and passionate oligonucleotide chemist to developing the next generation of RNA therapeutics. 2. The successful candidate will use state-of-the-art techniques to enhance RNA stability and improve cell delivery, as well as aid in the development of unique therapeutic platforms to discover new RNA molecules. 3. To lead the 2-3 chemists team along with responsibility of the person will systematically explore new and current chemical modifications to improve drug efficacy. He/she will be highly skilled in synthesising, analysing, and handling modified oligonucleotides and have the ability to adapt to a fast-paced research environment. Key Responsibilities: 1. Lead the development and chemical synthesis of modified oligonucleotides using automated solid phase synthesis (SPS) 2. Utilise a variety of purification and analytical techniques to evaluate the purity and structural integrity of newly synthesised ONs 3. Collaborate closely with closely with CFT team to understand the problems and solution. 4. Utilise expertise to generate libraries of therapeutic RNA and generate the data for AI algorithms Key Capabilities: 1. Excellent knowledge of solid phase ON synthesis,. 2. Phosphoramidite chemistry, and hands-on experience with automated ON synthesizers 3. Advanced and up-to-date knowledge of ON protecting groups and different deprotection strategies in SPS 4. Expertise in characterisation and purification of ONs and their conjugates by LCMS and HPLC 5. Strong analytical aptitude with an ability to work at the interface of chemistry and biology 6. Excellent communication and interpersonal skills 7. Ability to voice opinions and share ideas with the rest of the team 8. High professional integrity and commitment to excellence in execution 9. Passion for realizing the potential of fundamental scientific discoveries and commercialization Qualifications and work experience: 1. PhD or equivalent ( M.Sc organic chemistry) in ON/peptide/synthetic organic chemistry (postdoctoral or industrial experience in the SPS is preferred) 2. Strong understanding of nucleic acid modalities, modifications, and conjugation chemistry 3. Strong track record of scientific contributions, including peer reviewed publications or patent applications Scientist Position: Key Capabilities: 1. 3-5 years of work experience with M.Sc . organic chemistry 2. Good track record/excellent knowledge of solid phase ON synthesis/peptide synthesis 3. Excellent communication and interpersonal skills 4. Expertise in characterisation and purification of ONs and their conjugates by LCMS and HPLC 5. Planning in the daily reactions, maintain the LNB, safety 6. Good skills in purification 7. Knowledge in Identification and characterization of impurities 8. Experience in the preparation of PDR/MFR etc.. Qualifications and work experience: 1. M.Sc organic chemistry with 3-5 years of experience in Oligonucleotides/Peptides and complex molecules.

Position: API R&D Senior manager/AGM Experience: 12-15 years of experience after Ph.D in API R&D Qualification: M.Sc Organic Chemistry with Ph.D/preferably post-doctoral research experience. To lead a team of 15-20 chemists from API R&D. To develop and produce cost-effective, non-infringing, safe and eco-friendly technologies for the synthesis of reliable APIs and intermediates. Creative capabilities in the areas of organic chemistry in designing and conducting multi step organic synthesis that is very much attractive from commercial aspects, To Identifying and select API molecules based on developing Non-infringing process for API molecules Support in transformations in synthetic organic chemistry aimed at target molecule from R&D scale to plant scale . Good skills in interpretation of NMR, Mass spectra,, IR, GC, HPLC and XRD . Strongly self-motivated, believing in team work and efficient problem solver, having good skills for development of subordinate potentials. Exhibit Good Laboratory Practice. Efficient handling of High pressure, Hazardous, Highly moisture sensitive and other specialized reactions. API- cost effective process development. Optimizing the process by considering the yield, quality, cost and safety operations of the process. Data generation for DMF filing of final APIs. Preparation of Process Development Report/TTD to transfer technology to pilot plant. Impurity impact on process, identification & synthesis Development of new API molecules and technology transfer of the same. Process improvement for cost reduction and easy technology transfer. To facilitate the smooth and effective flow of resources between departments like R&D, ADL, CVC, RA, SCM, QA, Production and technology transfer. To prioritize the customer issue and communicate with necessary action.

Will be responsible for sales and marketing of Chronic Cluster products in Hyderabad/Vijayawada HQ.

Position Title: Site Head Engineering Department: Engineering & Maintenance Location: Padra, Vadodara Position Summary: The Site Head – Engineering (GM/Sr. GM Level) will be responsible for overseeing and managing the entire engineering and maintenance functions for both Pharma (Formulations) and Lifesciences (API) operations at the Padra, Vadodara site . The role demands a strategic leader with regulated market exposure , extensive experience in handling USFDA audits , and expertise in engineering operations, containment systems, and facility maintenance . The ideal candidate must have hands-on experience handling cytotoxic product equipment, isolators, HVAC systems with BIBO (Bag-In Bag-Out), wet scrubbers, OEL (Occupational Exposure Limit) studies, containment design, and maintenance to ensure compliance with stringent regulatory requirements. Key Responsibilities: Engineering & Maintenance Leadership: Lead the overall engineering function for Formulations and API operations, ensuring smooth plant operations and regulatory compliance. Develop and implement engineering strategies to optimize production efficiency, minimize downtime, and ensure cost-effective maintenance . Drive the preventive and predictive maintenance programs for all critical equipment and utilities. Regulatory Compliance & Audit Readiness: Ensure the engineering function complies with USFDA, EU GMP, MHRA , and other global regulatory standards. Play a key role in handling USFDA and other regulatory audits as the Engineering Head , ensuring all compliance requirements are met. Maintain audit readiness by implementing best practices in equipment qualification, validation, and documentation. Ensure that containment systems and OEL study protocols are in compliance with regulatory and safety standards. Project Management & Facility Upgradation: Lead expansion, upgradation, and modernization projects for both formulation and API facilities , with a focus on cytotoxic manufacturing and containment technology. Oversee capital expenditure (CAPEX) projects , ensuring timely completion within budget . Implement energy efficiency and sustainability initiatives to optimize operational costs. Supervise containment design, isolators, and wet scrubber systems to ensure compliance with occupational exposure guidelines. Utilities & Equipment Management: Manage and maintain critical utilities such as HVAC with BIBO (Bag-In Bag-Out) systems, purified water systems, compressed air, and effluent treatment plants . Ensure the availability and optimal performance of manufacturing equipment, clean rooms, reactors, packaging lines, and cytotoxic handling systems for both formulations and API production. Implement automation and digitization in engineering processes for better efficiency, compliance, and data tracking. Conduct OEL studies and monitor exposure control measures to ensure workplace safety and regulatory adherence. Safety, Environment & Compliance: Ensure adherence to HSE (Health, Safety & Environment) policies and drive a culture of safety in all engineering operations. Monitor environmental compliance , including effluent treatment, hazardous waste management, and containment system validations as per local and international guidelines. Ensure all containment design and maintenance protocols adhere to industry best practices to minimize occupational exposure risks. Team Leadership & Development: Build and lead a high-performing engineering team , ensuring continuous skill development and performance management . Foster a culture of innovation, accountability, and operational excellence within the engineering function. Train teams on cytotoxic product handling, isolator maintenance, and containment best practices to enhance technical expertise. Qualifications and Experience: Education: B.E. / B.Tech in Mechanical, Electrical, Chemical, or Industrial Engineering . A Master’s degree or certifications in Engineering Management, Industrial Automation, or GMP Compliance will be an added advantage. Experience: Minimum 15+ years of experience in the pharmaceutical industry , specifically in Formulations & API manufacturing facilities . Must have experience handling USFDA, EU GMP, and other international regulatory audits as the Engineering Head . Strong experience in managing engineering operations, plant maintenance, capital projects, and containment systems . Specialized Skills & Competencies: Regulatory Knowledge: Strong understanding of USFDA, EU GMP, and regulatory compliance in engineering functions. Containment Technology Expertise: Experience in handling cytotoxic product equipment, isolators, HVAC with BIBO, wet scrubbers, and OEL studies . Project Management: Hands-on experience in leading expansion and upgradation projects , including containment system installations . Leadership & Team Management: Proven ability to lead, mentor, and develop high-performing engineering teams . Problem-Solving & Innovation: Ability to drive continuous improvement and adopt new technologies for enhanced efficiency . Key Performance Indicators (KPIs): Audit Readiness & Compliance: Zero critical observations in regulatory audits. Operational Efficiency: Reduction in downtime and improvement in overall equipment efficiency (OEE) . Project Execution: Timely completion of CAPEX projects within budget . Energy & Cost Optimization: Implementation of cost-saving and energy-efficient initiatives. Safety & Environmental Compliance: Adherence to HSE standards with zero safety incidents . Containment System Effectiveness: Compliance with OEL limits and optimal performance of BIBO, isolators, and wet scrubbers .

Role & responsibilities Candidate having knowledge of Analytical method development and validation on various instrument like HPLC, GCHS and Dissolution. Also having knowledge of FDS with mass balance as per regulatory requirements.

Job Title: Manager / Sr. Manager HR & Admin Location: Mumbai (Head Office) Reports To: Group Head – HR & Admin Department: Human Resources & Administration Experience Required: Minimum 12 years Industry Preference: Pharmaceuticals (mandatory) Team Size: Will lead a team of 5 HR & Admin professionals Travel: Occasional visits to Bhiwandi Warehouse and field sales locations (as required) About BDR Pharmaceuticals: BDR Pharmaceuticals is a leading Indian pharmaceutical company committed to innovation, quality, and excellence in oncology, critical care, dermatology, and chronic therapies. With operations spanning manufacturing, R&D, and a pan-India sales force, BDR is one of the fastest-growing players in regulated markets. Role Summary: We are seeking a dynamic and experienced HR professional to lead the HR & Admin function for our Mumbai Head Office , Mother Warehouse at Bhiwandi , and four Ethical Marketing Divisions (Oncology, Critical Care, Derma, and Chronic) . The incumbent will be responsible for end-to-end HR and administrative management, ensuring alignment with organizational goals and fostering a culture of performance, compliance, and engagement. Key Responsibilities: A. Strategic HR Leadership Serve as the HR Business Partner for all HO functions, warehouse operations, and ethical sales divisions. Align HR strategies with business objectives across sales, logistics, and support functions. Lead the design and implementation of HR policies, SOPs, and compliance frameworks. B. Talent Acquisition & Workforce Planning Drive end-to-end recruitment across HO departments, warehouse, and field force. Coordinate with internal stakeholders and the TA CoE to ensure timely hiring of quality talent. Support manpower forecasting and budgeting for assigned verticals. C. Performance Management Ensure smooth execution of the annual appraisal cycle including KRA setting, mid-year reviews, and final evaluations. Provide guidance on managing low performance, including designing and implementing PIP frameworks. D. Employee Engagement & Communication Plan and execute employee engagement activities and internal communication campaigns. Foster a culture of trust, transparency, and motivation across teams. Ensure consistent connect with field sales teams across regions. E. HR Operations & Admin Oversight Oversee payroll, attendance, leave, F&F settlements, employee data management for assigned units. Ensure timely grievance redressal and disciplinary actions in compliance with company policy. Manage administrative responsibilities for HO and Bhiwandi warehouse – including facilities, contracts, security, and compliance. F. Statutory Compliance & Audit Readiness Ensure 100% compliance with statutory norms under Shops & Establishment Act, PF, ESIC, POSH, etc. Liaise with internal auditors, external vendors, and government authorities for inspections and certifications. G. Team Development & Leadership Lead, mentor, and develop a team of 5 HR and Admin professionals. Drive accountability, skill development, and service orientation within the team. Key Requirements: Educational Qualification: MBA / PGD in HR from a reputed institute. Experience: Minimum 12 years in HR, with at least 3–5 years in a similar leadership role in the pharmaceutical sector . Domain Exposure: Strong understanding of pharma field force dynamics, HO functions, and warehouse HR operations. Skills: Strong knowledge of Indian labor laws and compliance norms. Excellent communication, interpersonal, and stakeholder management skills. Analytical mindset with experience in HR analytics and dashboards. Proficiency in MS Office, HRMS tools, and payroll software. Desirable Attributes: Experience in handling geographically spread teams (field force). Exposure to digital transformation in HR (automation, data-driven decision-making). Ability to work in a high-performance, compliance-driven, and fast-paced environment.

Job Title: Executive Administration Location: Mumbai (Head Office) Department: Administration Reports To: Manager / Sr. Manager – HR & Admin Experience Required: Minimum 5 years in Office Administration Industry Preference: Pharma or other Corporate Setup (preferred) Role Summary: BDR Pharmaceuticals is looking for a proactive and responsible Executive – Administration to independently manage all administrative operations at the Head Office and support the functioning of the Management House. The candidate must have strong coordination abilities, attention to detail, and the capability to handle end-to-end administrative tasks, ensuring smooth operations and adherence to company policies. Key Responsibilities: A. General Administration Ensure daily smooth functioning of the Head Office administrative activities. Act as the single point of contact for all facility-related requirements and concerns. Maintain cleanliness, hygiene, and maintenance across office premises and Management House. B. Office Infrastructure & Facility Management Coordinate for regular repair, maintenance, and upkeep of office equipment, furniture, and premises. Handle AMC contracts, utility services (electricity, water, internet), and liaise with vendors and service providers. Monitor security services, pantry services, and housekeeping performance. C. Stationery & Office Supplies Maintain inventory of office stationery and consumables. Ensure timely procurement and distribution of materials with cost-efficiency and quality. Track and manage usage, wastage, and replenishment schedules. D. Courier & Dispatch Management Handle all incoming and outgoing courier services and logistics for the Head Office. Ensure proper documentation, tracking, and timely dispatch/delivery of documents, samples, and parcels. Coordinate with courier agencies and ensure service level adherence. E. Meeting Room & Event Coordination Manage bookings and setup of meeting rooms and conference facilities. Arrange logistics for internal and external meetings, visitors, interviews, and corporate events. Support in organizing company functions, celebrations, and vendor meetings. F. Admin Records & Budget Monitoring Maintain proper documentation of admin expenses, vendor contracts, bills, and approvals. Coordinate with Finance for timely invoice processing. Track and report monthly administrative expenses against the approved budget. Key Requirements: Education: Graduate in any discipline; Diploma in Facility Management / Administration preferred. Experience: Minimum 5 years of relevant experience in handling corporate admin functions. Skills & Competencies: Strong organizational and time management skills. Hands-on experience with vendor management, office maintenance, and logistics. Good communication skills and ability to coordinate with multiple stakeholders. Working knowledge of MS Office and familiarity with basic admin software/systems. Desirable Traits: Experience in managing administration for Pharma HO or similar regulated industry. Proactive approach with problem-solving skills. Ability to multitask and independently manage priorities. Service-oriented mindset with attention to compliance and internal customer satisfaction.

Company Description Established in 2002, BDR Pharmaceuticals is a leading company in the API manufacturing and global pharmaceutical market with a focus on specialty medication. BDR Pharmaceuticals ensures critical, and lifesaving medicines are available at affordable prices through its unique strategy of multi-branding. The company operates two API and formulation facilities in Gujarat and Uttarakhand, along with a pellet facility in Hyderabad. Role Description Prior art & patentability search Patent drafting, filing & prosecution FTO analysis Preparation of patent query response to customer Infringement analysis & invalidity opinion To maintain internal IP databases New product identification & selection inputs Litigation support Preparation of IP risk mitigation strategy Monitoring of IP updates & competitive intelligence Prepare MIS reports on regular basis& provide to department head Support to R&D, BD, PMO and RA Qualifications Experience in managing intellectual property rights and legal documentation Knowledge of conducting patent searches Understanding of IPR regulations and compliance Excellent communication and negotiation skills Detail-oriented and analytical mindset Bachelor's degree in Pharmacy.

To support and execute end-to-end regulatory documentation and review for site transfer projects, from data collation to submission. Key Responsibilities: Coordinate data collection from CFTs for pre submission and site transfer packages. Review all plant-related documents Prepare and submit dossiers for product registrations in Europe, US, UK, Canada, Australia, Brazil markets, ensuring adherence to country-specific guidelines and requirements. Prepare and maintain regulatory trackers. Support query responses and internal audits related to site transfers. Ensure documentation quality and compliance with ICH/FDA/EU/Health Canada guidelines. Qualifications: M. Pharm with 48 years of RA experience. Hands-on in Module 3, eCTD components, and lifecycle submissions. Familiarity with change management systems (Trackwise or similar).

Manager / Sr. Manager Regulatory Affairs (US Team) Reports To: Head – Regulatory Affairs Market: US and EU Location: Vadodara Job Purpose: To lead site transfer regulatory activities, ensuring timely compilation, review, and submission of ANDA variations, change controls, and query responses to health authorities like USFDA, EU and Health Canada. Responsibilities: 1. Regulatory Submissions and Approvals: Prepare Review and submit dossiers for product registrations and post approval changes in US or Europe markets, ensuring adherence to country-specific guidelines and requirements. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions. Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies. 2. Compliance and Documentation: Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulations). Maintain accurate and up-to-date records of regulatory documents, approvals, and communication. Monitor and ensure compliance with post-marketing regulatory requirements such as periodic updates, renewals and reporting obligations. 3. Labeling and Packaging Compliance: Review and approve labeling and packaging materials to ensure they meet the regulatory requirements of each country in the assigned regions. Coordinate changes in labeling as per the updated guidelines and regulations from local health authorities. 4. Product Development Support: Work closely with product development teams to ensure regulatory requirements are considered during product formulation and development. Provide regulatory advice on technical issues related to injectables, including formulation, packaging, and stability studies. 5. Regulatory Intelligence: Stay updated on changes in regulations, guidelines, and standards in the Europe, US, UK, Canada, Australia, Brazil regions. Communicate any changes or updates in regulatory requirements to relevant departments and ensure compliance with new regulations. 6. Communication and Coordination: Act as a point of contact between the company and regulatory bodies in the assigned markets. Coordinate with external partners, consultants, and distributors to facilitate regulatory submissions and product launches. 7. Cross-functional Collaboration: Collaborate with Quality Assurance, Manufacturing, and R&D teams to ensure that regulatory requirements are met at every stage of product development and manufacturing. Support in audits and inspections conducted by regulatory agencies and provide necessary documentation and information. 8. Product Registration Lifecycle Management: Manage the entire lifecycle of product registrations, including initial submissions, renewals, variations, and amendments. Ensure timely submission of regulatory documents to maintain product approvals and licenses. 9. Risk Management and Problem-Solving: Identify potential regulatory risks and devise strategies to mitigate them, ensuring uninterrupted market access for products. Provide solutions and regulatory strategies to resolve any issues or challenges related to regulatory submissions. Additional Responsibilities: Review documents, identify gaps, and guide team members on remediation. Communicate with partners and regulatory agencies for clarification and status updates. Manage timelines, risk mitigation, and submission tracking. Train and mentor junior team members. Qualifications: M. Pharm with 8–12 years in US/EU regulatory affairs. Strong understanding of CMC, change control, and Module 3. Experience in pre and/or post-approval submissions and site transfers.