Dr. Reddy's Lab jobs - 32 jobs

At Dr. Reddy's "Good Health Can't Wait" By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. Diversity, Equity & Inclusion At Dr. Reddy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Job Description We are seeking an Intellectual Property (IP) Counsel to join our Princeton, NJ office . This role will report directly to the Head of Intellectual Property for North America As an Attorney in the IP department, you will collaborate with internal and external stakeholders to design and implement IP strategies to advance Dr. Reddy's interest to provide affordable health care solutions. This role will provide counsel on patent litigations in North America (both small and large molecule), and be responsible for the entire life-cycle of a project from selection to launch and will require extensive interaction with Portfolio, R&D, Business Development, and Regulatory Affairs. Responsibilities: Manage patent litigations in North America, including ANDA/ANDS, 505(b)(2) and biosimilar litigations, including post-grant patent office proceedings by developing and implementing claims and defenses Secure freedom-to-operate for Dr Reddy's products, including clearance of Orange Book and unlisted patents for the bulk API, route of synthesis, finished dosage form and polymorphs Prepare ANDA patent certifications and the corresponding notice letters and detailed statements Examine patents, file histories, prior art, ongoing litigations, and citizen's petitions for possible Paragraph IV and related strategies for ANDA/ANDS, 505(b)(2), and BPCIA products Conduct IP due diligence and provide IP support towards business development activities Manage drafting and prosecution of patent applications Advise internal stakeholders on all aspects of pharmaceutical patent and regulatory law, including exclusivity issues and launch scenarios Qualifications Educational qualification: A Juris Doctor from a recognized, accredited law school and licensed to practice in New Jersey or in at least one other state with eligibility to apply for limited New Jersey in-house counsel legal license. Registered to practice before the U.S. Patent and Trademark Office preferred . Minimum of a Bachelor's Degree in Science or Engineering. Degree in Chemistry, Biochemistry, or similar discipline preferred. Advanced degree highly preferred Minimum work experience: 8+ years of patent litigation experience, including significant experience in Hatch-Waxman matters Skills & attributes: Patent litigation experience. Significant experience in Hatch-Waxman matters. Exhibit leadership by example, effort and attitude. Ability to work independently. Additional Information Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring visa transfer or sponsorship, now or in the future. Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process. Our Work Culture Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. For more details, please visit our career website at ********************************

1. Equipment & Facility Maintenance Lead maintenance of OSD manufacturing equipment such as blenders, granulators, fluid bed dryers, sifters, mills, tablet presses, capsule fillers, coating pans, dust collectors, compressors, chillers, boilers, AHUs, and dehumidifiers. Implement robust Preventive Maintenance (PM) and predictive maintenance programs. Conduct breakdown investigations and implement corrective actions. Ensure critical facility systems (HVAC, electrical, plumbing, fire systems, BMS/EMS) are maintained and operate to required standards. 2. Regulatory Compliance & Documentation Ensure compliance with FDA, cGMP, 21 CFR Part 11, OSHA, and related regulatory requirements. Maintain records including PM logs, calibration reports, service documentation, change controls, deviations, and CAPAs. Support internal and external audits (FDA, DEA, ISO, and customer audits). 3. Utilities & HVAC Systems Management Manage key utilities such as compressed air, nitrogen, vacuum, HVAC, chilled water, steam, and RO/DI water systems. Ensure qualified and compliant environmental controls for classified OSD manufacturing areas. Maintain pressure cascades, temperature and humidity controls, and HEPA-filtered air systems. 4. Equipment Qualification & Validation Work with Validation and QA teams on IQ/OQ/PQ protocols. Manage requalification schedules and ensure equipment remains in a validated state. Provide engineering assessments for change controls. 5. Safety, Risk Management & Compliance Ensure adherence to OSHA, NFPA, and site safety requirements. Implement safety programs including LOTO, confined space, hot work, and electrical safety. Conduct incident investigations and lead corrective actions. 6. Spare Parts & Vendor Management Maintain optimum inventory of critical spare parts. Manage vendors, annual maintenance contracts (AMCs), and service agreements to control maintenance costs. Evaluate and onboard modern technologies and suppliers. Qualifications & Experience Education: Bachelor's degree in mechanical, Electrical, Chemical, or Industrial Engineering (or equivalent). Preferred: Master's degree or certifications such as CMRP or PMP. Experience: 8-15 years of engineering and maintenance experience in OSD pharmaceutical manufacturing. Strong knowledge of manufacturing and packaging equipment, utilities, HVAC, and cleanroom systems. Experience with FDA/DEA audits and equipment validation. Must have a valid work permit.

Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines. Eugia's mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia's capabilities to include the manufacture of highly complex injectables to answer that need. Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals. Job Overview The Supply Chain Associate will support supply planning and managing shipments for continuous product supply chain improvements. This will include managing supplies for new product launches etc., issuing internal orders to assure continuous supply product and tracking of logistic documents. This role is located onsite in East Windsor New Jersey with one (1) day a week remote. The qualified candidate must live within a commutable distance to the home office. This position is not eligible for sponsorship or relocation. Responsibilities * Prepare and review Warehouse inventory data and maintain master data in Oracle. * Perform inventory scrutiny and reconciliation and adequacy disposition of all inventory items for Eugia and Cardinal warehouses. * Prepare supply chain data on product movement and analysis - Inbound and outbound shipments * Auditing invoices and Purchase Order (PO) control including custom duty. * Assist on incoming shipment document / PO Tracker to department colleagues. * Collecting analysis of inbound and outbound KPIs (APL and AMP) * Review Short Date Inventory and Maintain Exception handling registers. * Analysis of Failure to Supply (FTS) on a monthly basis to provide support / analyses on prioritization * Track the API and Key Preproduction Meeting supply status including New Product Launch in the current pipeline for ready to launch * Supply planning file preparation for Monthly review and collaborate with customer service, sales and Marketing and regulatory team. This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Qualifications - Skills & Requirements * Strong verbal and written communication skills to ensure clarity and accuracy across interdepartmental and cross-functional teams * Proficiency in advanced Excel functions and data analysis techniques to support inventory tracking, reporting, and decision-making * Ability to multitask, handle multiple issues and work under pressure while maintaining composure * Prioritizing tasks in a fast-paced, deadline-driven environment * Proactive mindset to identify inefficiencies and suggest improvements * Excellent attention to detail, organization and time management skills Education & Experience * BA/BS degree in Supply Chain or related field required * 1+ year of experience in the pharmaceutical industry * 1-2 internships in pharmaceutical supply chain strongly preferred * APICS Certification a plus The hourly pay rate for this position may go up to $34.00 per hour, depending on factors such as experience level, knowledge, skills, and abilities. Final compensation decisions will consider these and other relevant business needs. In addition to base salary, this position is eligible for an annual bonus, with target percentages varying by role. The total compensation package may also include discretionary incentives and role-based monthly allowances (e.g., cell phone or car allowance, where applicable). Health and Welfare Offerings: * Medical Insurance: Choice of four Horizon Blue Cross Blue Shield of New Jersey plans - PPO, EPO, HDHP, and OMNIA. Premiums and coverage vary by plan. * Prescription Coverage: Included with medical insurance; tiered copays based on medication type. * Dental Insurance: Choice of three plans - DHMO, Core PPO, or Buy Up PPO plans. * Vision Insurance: Choice of two plans - Base and Buy Up options. * Life and AD&D Insurance: Company-paid Basic Life and AD&D (1x annual salary up to a specified maximum), with optional Supplemental coverage. * Disability Insurance: Voluntary Short-Term Disability (employee-paid); Long-Term Disability is company-paid. * Flexible Spending Accounts (FSAs): Available for health care and dependent care expenses. * Health Savings Account (HSA): Offered with HDHP enrollment; employee-funded. * Voluntary Benefits: Identity Theft Protection, Critical Illness Insurance, Accident Insurance, and Legal Insurance (all employee-paid). * Employee Assistance Program (EAP): Confidential support services at no cost. * 401(k) Retirement Plan: Pre-tax and Roth contribution options available, with company match; vesting applies. * Paid Time Off: Includes vacation, PTO, and company holidays (varies by role and tenure). * Employee Referral Program: $1,000 bonus for each qualified hire you refer. Physical Requirements OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements No Additional Requirements Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

We are seeking an innovative and technically skilled IT Business Analyst with 5+ years of experience, preferably in pharmaceutical sales and distribution. The ideal candidate will possess expertise in SAP S/4HANA (SD, FI, MM, PP, QM modules) and Vistex Revenue Management in a business facing role, with a strong understanding of core business processes such as finance, supply chain, sales, and revenue management. This role requires a blend of business acumen and technical capability to analyze requirements, design solutions, and drive process improvements. The candidate will work closely with different teams to understand business needs, support data-driven decisions, and apply modern technologies such as AI, automation tools, and machine learning to improve processes and drive innovation. ESSENTIAL DUTIES AND RESPONSIBILITIES Collaborate with business users to elicit, analyze, and document functional and non-functional requirements. Identify and drive process improvement initiatives to optimize operational efficiency and ensure compliance with industry standards and best practices. Perform data analysis to uncover actionable insights, identify root causes of issues, and detect trends that inform strategic decisions and continuous improvement. Create and maintain key artifacts including process flows, data flows, system architecture diagrams, business cases, functional specifications, and other documentation to support solution design, implementation and stakeholder understanding. Collaborate with technical teams to ensure proper configuration, integration, and optimization of solution. Lead and support testing activities, including system validation and facilitation of User Acceptance Testing (UAT), ensuring solutions meet defined requirements and quality standards. Assist in change control, deployment planning, and execution to ensure smooth transitions and minimal disruption to business operations. Develop and manage project plans, timelines, and deliverables, ensuring successful execution of initiatives within scope, budget, and schedule. Develop, maintain, and enhance dashboards and reports using tools such as Microsoft Fabric BI to support real-time business intelligence and performance monitoring. Conduct user training sessions and create documentation to support the adoption and effective use of new technologies, systems, and processes. KNOWLEDGE / SKILLS /COMPETENCY Excellent verbal and written communication skills, with the ability to convey complex concepts clearly to both technical and non-technical audiences. Exceptional organizational, prioritization, and time management skills, with the ability to manage competing priorities and adapt to changing business needs. Analytical mindset with the ability to define and solve complex problems, even when faced with incomplete or ambiguous information. Self-driven and proactive, with the ability to work independently and take ownership of tasks with minimal supervision. High level of initiative and accountability, consistently driving tasks to completion and delivering results. Requirements EDUCATION/EXPERIENCE Bachelor's degree in business administration, Information Systems, Data Analytics, or a related field. 5+ years of experience as a business analyst, preferably within the pharmaceutical sales and distribution industry. Industry-specific knowledge of the generic pharmaceutical sector is desirable. Hands-on experience with SAP S/4HANA modules (SD, FI, MM, PP, QM) and Vistex Revenue Management is strongly preferred. Experience working with pharmaceutical-specific processes such as Government Pricing, Medicaid, Chargebacks, Fees and Incentives or Gross-to-Net (GTN) calculations is desirable. Knowledge of regulatory and compliance requirements in the pharmaceutical industry. Other Preferred Skills and Experience: Microsoft Fabric or similar platforms for data analytics, reporting, and business intelligence. Salesforce Service Cloud for customer support operations. Tracelink Serialization or similar for pharmaceutical product tracking and compliance. Cloud platforms such as Microsoft Azure or Amazon Web Services (AWS). Project management expertise, including certifications such as PMP or Agile, and hands-on experience with tools like Planview, JIRA, ALM, Microsoft Project, and Azure DevOps. Cloud-based AI/ML platforms such as Azure AI, Google AI, or AWS ML. Python, R, and SQL for data analysis, automation, and predictive modeling. RPA platforms (e.g., UiPath, Automation Anywhere) and implementing automation solutions. WORK ENVIRONMENT The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is: Frequently required to sit and/or stand, walk, talk and hear. Constantly required to use hands and fingers to operate office machines and equipment. Frequently required to reach with hands and arms. Occasionally required to stoop, kneel and crouch. Required to occasionally lift, carry, push, pull, or otherwise move objects. Occasional travel required between various locations in US and some international travel. The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job. Zydus Pharmaceuticals (USA) provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Zydus is committed to providing reasonable accommodation to, among others, individuals with disabilities and disabled veterans. If you need an accommodation because of a disability to search and apply for a career opportunity with Zydus, please contact us and let us know the nature of your request. Salary Description $140,000-$160,000

Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines. Eugia's mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia's capabilities to include the manufacture of highly complex injectables to answer that need. Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals. Job Overview Under the oversight of the Associate Manager of QA Compliance, the Quality Compliance Associate will be responsible for establishing the internal QA review system to supervise the PVG function, handled by third party. Also, responsible for creating a QA system to notify FDA of Illegitimate Products, as and when needed. This position will also be reviewing all Eugia finished product batches for compliance with applicable regulatory and cGMP requirements prior to release for commercial distribution, as needed. Maintenance and/ or improvement of the Eugia quality systems necessary to support GMP related activities will also be required. The Quality Compliance Associate position is based in East Windsor New Jersey and not eligible for relocation or sponsorship. This is a short‑term (6 months) hourly role. While there is a possibility of conversion to full‑time permanent status, this outcome is not guaranteed. Responsibilities * Prepare, Review and Finalize the SOPs, MAPPs, Internal Guidelines, Review Checklist to supervise the PVG function of Eugia's products. * Coordinate with Third-party PVG team to establish the standard review process of PVG Reports, generated for Eugia's products. * Prepare, Review and Finalize the SOPs, MAPPs, Internal Guidelines for creating a QA system to notify FDA of Illegitimate Products, as and when needed. * Coordinate & Communicate with Cross-functional team (CFTs) to gather the required data/information to notify FDA of Illegitimate Products. * Assist Associate Manager of QA Compliance to notify FDA of Illegitimate Products within FDA's pre-defined timeline. * As and when needed, conduct Social Media Monitoring for any product quality/safety related complaints for Eugia's product and inform the third part PVG team for further processing. * Compile and archive the batch related documents. Keep all GMP records in compliance with Good Documentation Practices. * Provide periodic updates to immediate manager on Quality related concerns. This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Qualifications - Skills & Requirements * Effective communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams. * Strong computer skills, including proficiency in Microsoft Office Suite. * Commitment to maintaining a high level of integrity and professionalism. Education & Experience * Bachelor's degree in a scientific or related field. * Previous experience in quality assurance or quality compliance role, preferably in a regulated industry such as pharmaceuticals, medical devices etc. * Brief Knowledge of PVG, Form 3911, SOPs, Change Control Processes, CFR & GMP Regulations. * 1-2 years' experience in the Pharmaceutical/Biotech industry with knowledge of cGMP regulations as they pertain to API and sterile finished drug products. * Previous experience in Quality Assurance/Compliance is preferred. The hourly pay rate for this position may go up to $34.00 per hour, depending on factors such as experience level, knowledge, skills, and abilities. Final compensation decisions will consider these and other relevant business needs. In addition to base salary, this position is eligible for an annual bonus, with target percentages varying by role. The total compensation package may also include discretionary incentives and role-based monthly allowances (e.g., cell phone or car allowance, where applicable). As a temporary role upon hire, this position is not eligible for company sponsored Health and Welfare benefits. Physical Requirements OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements No Additional Requirements Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

Job DescriptionDescription Zydus Pharmaceuticals (USA) Inc. is seeking a summer intern interested in joining our team in Pennington, NJ. The intern will have an opportunity to learn about the generics industry, assist with projects that will have a meaningful impact to the organization, and have an opportunity improve current processes. The internship will be office-based and begin in May and end no later than August. Zydus Pharmaceuticals (USA) Inc. is a globally integrated generic pharmaceutical company with a focus on providing high service, quality, and affordable products. Our US leadership, which has over 60 years of US generic market experience, understands the customer's business which allows Zydus the ability to provide unique models to help drive their customer's success. Our parent company, Zydus Lifesciences, has a large presence in global markets, including relationships with many top tier international pharmaceutical companies. Based on a manufacturing and development history that spans over 50 years, it is the 4th largest pharmaceutical company in India. Requirements RESPONSIBILITIES: • Work with pricing and marketing teams to analyze competitive data • Assist with preparation of dashboards and reporting requirements • Review current reports and brainstorm ways to streamline reporting • Shadow pricing team to learn and understand business operations • Assist with researching data related to price transparency reporting • Assist with any other ad hoc projects QUALIFICATIONS - SKILLS & REQUIREMENTS: • Excellent communication skills • Strong analytical and problem-solving abilities • Quantitative mindset • Ability to work both independently and in a team environment • Proficiency in Microsoft Office • Must be legally authorized to work in the United States without restriction • Must be 18 years of age or older EDUCATION & EXPERIENCE: • Must be an undergraduate or graduate student in good academic standing TRAVEL: • None WORK ENVIRONMENT: This is an office-based position, located in our office in Pennington, NJ. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is: • Frequently required to sit and/or stand, walk, talk, and hear. • Ability to sit at a computer for an extended period of time. • Vision ability requirements include clarity of visions at 20 inches or less due to computer work. • Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic). • Constantly required to use hands and fingers to operate office machines and equipment. • Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch. The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job.

Medical Affairs Biostatistician The role is responsible for statistical activities in support of Medical Affairs, including post approval value evidence generation, secondary publications, post marketing study design and study protocol development, analysis and reporting of observational or clinical study data, and other post hoc and exploratory analyses as needed. In addition, this role is also responsible delivering analysis outputs without programmers support. Summary of Key Responsibilities + Leads statistical support for post approval value evidence generation and reimbursement submissions + Conducts post hoc analysis to support publications and presentations + Reviews and authors abstract, manuscript, regulatory documents + Collaborates with cross-functional team to support observational studies + Develops statistical sections of study protocols and statistical analysis plans. + Collaborates with Data Management and Medical Research on design of eCRFs. + Provides statistical guidance on conduct of ongoing studies. + Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs + Contributes to observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc. + Contributes to scientific articles, summarizing data collected in sponsor studies. + Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed. Qualifications + PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years' relevant experience. + Excellent written and oral communication and presentation skills. + Strong SAS programming experiences and expertise and are comfortable delivering analysis outputs without programmers support. + Extensive experiences working on data analysis with clinical studies database + Experience working on post-approval observational and clinical studies. + Understanding of ICH GCP as well as general knowledge of industry practices and standards. + Experiences in R programming language and other statistical software. + Experience with CDISC, including SDTM, ADaM, CDASH. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

We are seeking a Director / Lead External Manufacturing to lead operations for North America, to ensure reliable supply of commercial products and support new product launches. The position manages relationships with Contract Manufacturing Organizations (CMOs) and Contract Packaging Organizations (CPOs), driving operational excellence, compliance, and cost efficiency while collaborating with internal stakeholders across Quality, Supply Chain, Regulatory, Technical Services, and Commercial teams. Responsibilities: Supply Assurance & Operations * Coordinate with CMOs/CPOs to ensure on-time, in-full (OTIF) delivery of cGMP compliant, and quality reviewed and released FG and Bulk drug products to customers and markets * Determine supply priorities through interaction with the Global Supply chain and External Manufacturing (EM) team members on a regular basis and communication of these priorities and changes to the relevant CMO/CPO * Understand CMO's capacity constraints, bottlenecks, material shortages etc. in the short medium and long term, aid resolution of these constraints & escalate to the supply chain management as needed * Manage the commercial product lifecycle, including raw material changes, artwork updates, process revalidations, packaging changes, and shelf-life extensions * Prepare and provide accurate monthly forecasts, purchase orders, and stock-transfer orders to the CMO's manufacturing sites in-order to meet forecasted demand and target inventory/MOH levels * Lead/participate in cross-functional due diligence teams to assess new business opportunities and potential capabilities of a new CMO * Review, approve, and submit CMOs invoices for timely payments Alliance & Relationship Management * Build and sustain strong partnerships and business relationship through effective alliance management with supply chain counterparts * Negotiate and manage Master Supply/service agreements and ensure adherence to the terms and conditions of the contract agreement though collaborative partnerships. * Communicate any inventory risks to EM inventory control, SCM and finance teams in a timely manner, and develop plan for risk mitigation of anticipated backorders at relevant CMO Compliance & Documentation * Ensure all compliance-related documents, such as batch records, COC/COA, etc., for each order are accurate and available for Quality Assurance review and release * Arrange permits, state licenses, quality agreements, and service agreements to maintain GMP/GDP compliance * Review of CMO related change controls to understand the supply chain impact. Work closely with QA, regulatory, commercial and packaging teams to facilitate risk assessment & impact, along with approval process for the changes proposed/implemented at the CMO * Ensure the complete set of shipping documents is provided by the CMO/CPO including packing list, commercial/custom invoice, certificate of origin, BOL/AWB/HWB, EPICS file and all approved copies of COC's and COA's at the time of shipment Data & Systems * Facilitate set up and validate material and vendor master data in SAP and related systems * Support the entire order-to-commercial cycle with proactive issue resolution * Liaison and support DSCSA compliance and serialization requirements with CMO's Serialization team, collaborate with internal IT, and 3PL warehouse to ensure complete and timely implementation of GS1 EPCIS process to meet FDA requirements for new product launches and CMO's on-boarded Continuous Improvement * Lead cost optimization projects with partners to improve throughput and efficiency * Drive initiatives to mitigate supply chain risks and enhance operational resilience * Participate and drive Alternate Vendor Development (AVD) projects for evaluating and validating new API, excipients and RM vendors for dual-sourcing, cost savings and reliability optimization Qualifications Educational qualification: Postgraduate degree with specialization in Operations Management, Supply Chain Management or related field Minimum work experience: 10+ years of experience in cGMP pharmaceutical manufacturing or supply chain operations Skills & attributes: * Proven experience in contract manufacturing management in an international environment * Strong operational expertise in pharmaceutical supply chain and generics business model * Proficiency in SAP, MS Office, and MS Project * Demonstrated ability to work with urgency, meet timelines, and ensure compliance * Excellent leadership and relationship-building skills across multicultural, multilingual environments * Strategic thinking with strong execution capability * Negotiation and alliance management skills * Problem-solving and proactive risk mitigation * Ability to influence across functions and geographies Incumbent must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring visa transfer or sponsorship, now or in the future. Incumbent should be willing to work in person from our Princeton, NJ office Additional Information Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process. Our Work Culture Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. For more details, please visit our career website at ******************************** *

The Group Lead, Supply Chain CoE - North America will lead the development and execution of scalable supply chain capabilities across planning, logistics, and operations within the North American region. Reporting to the Head of Supply Chain & External Manufacturing NA, this role will drive regional transformation through digital enablement, process innovation, and talent development. A key responsibility is to align the North America CoE roadmap with the Corporate CoE headquartered in India, ensuring regional execution of global strategies and standards while tailoring solutions to local market needs. These strategies will drive measurable improvements in service levels, inventory management, forecasting accuracy, cost efficiency, and talent development-impacting both the top and bottom line of the North American business. Responsibilities: 1. CoE Strategy & Operating Model for North America * Design and lead the North America Supply Chain CoE, aligning its charter and roadmap with regional business objectives and the global CoE strategy. * Collaborate closely with the Corporate CoE in India to ensure harmonization of frameworks, tools, and methodologies. * Translate global supply chain strategies into actionable regional initiatives, ensuring relevance and impact in the North American context. * Serve as the regional voice in global forums, providing feedback and insights to shape enterprise-wide supply chain evolution. 2. Talent Management & Capability Building * Build and lead a regional supply chain talent strategy, including competency modeling, career pathing, and succession planning.. * Collaborate with HR and L&D to launch regional academies, mentoring programs, and certifications. * Establish Centers of Expertise for knowledge sharing and internal consulting across NA sites. 3. Operational & Process Excellence * Deploy standardized end-to-end supply chain processes across NA, leveraging SCOR Digital Standard and Lean Six Sigma. * Lead initiatives in IBP/S&OP/S&OE, inventory optimization, lead time reduction, and logistics network design specific to NA distribution and manufacturing footprint. * Embed continuous improvement culture through diagnostics and best practice replication across NA operations. 4. Digital Transformation & Innovation * Champion digital technologies (e.g., SAP IBP, Kinaxis, Control Towers, AI/ML) to improve agility and decision-making in NA. * Co-develop the regional digital roadmap in alignment with the global digital strategy and lead pilots and scale-up initiatives across NA supply chain functions. * Monitor technology trends and benchmark against regional best practices and competitors. 5. Program Management Office (PMO) & Initiative Deployment * Oversee PMO functions to ensure successful deployment of supply chain initiatives across North America. * Establish project governance, managing cross-functional project teams, and driving execution excellence. * Responsible for prioritizing initiatives, allocating resources, tracking milestones, and ensuring delivery of outcomes aligned with business objectives. 6. Performance & Value Delivery * Define and manage CoE success metrics for NA, including operational KPIs, maturity indices, and capability adoption rates. * Drive programs with measurable ROI such as cost-to-serve reduction, service level improvements, and sustainability targets. * Ensure alignment of KPIs across NA business units and establish governance reviews with regional and global leadership. Key Performance Indicators (KPIs) * Adoption rate of standardized supply chain processes across NA sites. * Improvement in supply chain maturity level based on ASCM/Gartner benchmarks. * Employee engagement and talent development scores within NA supply chain teams. * Cost-to-serve reduction across logistics and planning functions. * Forecast accuracy improvements via S&OP/IBP enhancements. * Lead time reduction for critical NA product lines. * Inventory turnover and DIO improvements post-CoE initiatives. * Successful implementation and adoption of digital tools across NA. * Degree of alignment and execution of global CoE strategies within NA. Qualifications Educational qualification: Bachelor's in Supply Chain, Business, Engineering; Master's preferred Minimum work experience: 15+ years in end-to-end supply chain leadership roles, including 5+ years in CoE or transformation roles within North America. Experience in pharma, life sciences, in North America Certifications: APICS CPIM/CSCP, Lean Six Sigma, or equivalent. Skills & attributes: * Experience deploying enterprise-wide systems (SAP IBP, APS, ERP, analytics platforms). * Strong knowledge of ASCM SCOR framework, Gartner Maturity Model, and NA regulatory landscape. * - Proven success in capability building, talent development, and change leadership in complex regional organizations * Proven success in capability building, talent development, and change leadership in complex regional organizations * Ability to work effectively in a multicultural environment; familiarity with Indian business culture and cross-border collaboration is highly desirable. * Demonstrated ability to manage cross-functional teams and regional stakeholders. * Experience working in matrixed organizations with global CoEs or shared services. Leadership Competencies: * People Developer: Empowers NA teams through coaching and growth paths. * Strategic Thinker: Connects long-term regional vision with execution. * Change Leader: Leads cultural and operational transformation across NA. * Collaborative Influencer: Builds trust across NA functions and partners, and with global CoE counterparts. * Digitally Fluent: Leverages data and tools to drive innovation and performance. Incumbent should be willing to work in person from our Princeton, NJ office Additional Information Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring visa transfer or sponsorship, now or in the future. Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process. Our Work Culture Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. For more details, please visit our career website at ******************************** *

**Who Are You?** An experienced Pharmacometrician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead quantitative pharmacology activities for clinical studies. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same. **Sponsor-dedicated:** Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Pharmacometrician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. **Position Overview:** Our Principal Pharmacometricians provide advanced analytical and development support and influence for the associated client's trials providing expertise into processes, regulatory strategy, modeling, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, produce PK/PD modeling, and align study team on strategy. **As a Principal Pharmacometrician, your responsibilities will include:** + Contribute to Pop-PK and PK/PD modeling, and non-compartmental analyses + Contribute to study design, including Bayesian/adaptive design methodologies + Create specifications and perform analyses such as time-to-event and longitudinal analysis. + Review and contribute to study reports and quantitative clinical pharmacology l sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities. + Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management. **Required** + Experience in Pop-PK and PK/PD modelling, and non-compartmental analyses + Understanding of the broader biopharmaceutical R&D process. + Excellent organization and multi-tasking capabilities, strong problem-solving and analytical skills. + Experienced in Phoenix WinNonLin and NLME, and R. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

At Dr. Reddy's "Good Health Can't Wait" By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. Diversity, Equity & Inclusion At Dr. Reddy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Job Description We are seeking a Packaging Engineer to support our North America Group's packaging commercialization efforts for their U.S. OTC store brand and owned brand business. This role will report to Lead Packaging Engineer Roles & Responsibilities Create and maintain packaging database. Create and edit as needed packaging documentation including pBOM and specifications. Develop dyelines for artwork working with the manufacturing facilities. Coordinate structural and artwork development process with graphic designers for new SKU development, commercial launches, and manage routine artwork changes. Provide critical inputs and requirements for product stability and FDA and other agency submissions. Qualification of primary and secondary/tertiary packaging systems. Execute testing as needed to support development and submission activities: USP testing; extractables & leachable; shipping tests; child resistance; line and component validation. Author, review, and coordinate approvals for documentation to support all activities as needed. Provide packaging structural engineering, development and design support Manage projects related to new product launch packaging activities, facilities and manufacturing changes. Manage suppliers and co-packers. Provide packaging oversight for activities and troubleshoot as necessary for startup, new product or SKU launches and support on-going production Initiate and execute primary and secondary package design projects. Qualifications Educational qualification: BS degree in Engineering (Packaging preferred, Mechanical, Materials Science) Minimum work experience: 2-6 years of experience in regulated industry (pharmaceutical or consumer products packaging with OTC packaging preferred). Skills & attributes: The candidate should have experience with variety of packaging on both primary (bottles, closures, blisters, pouches) and secondary/tertiary packaging (cartons, labels, shippers, displays). Experience with cGMP's, all applicable FDA guidelines and Quality Systems. Prefer additional understanding of ISO, USP, ISTA, ASTM standards. Comfortable working in a team environment with tight deadlines. Experience in packaging operations is desired. Excellent communication, technical writing, and presentation skills. Domestic travel may be required: up to 10-20% Additional Information Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring visa transfer or sponsorship, now or in the future. Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process. Our Work Culture Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. Equal Opportunity Employer An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. For more details, please visit our career website at ********************************

Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992. AuroPackaging (APK) is a division of Aurobindo USA that plays a primary role in converting the Bulk from our manufacturing sites to Finished Goods (FG) as per requirements. AuroPackaging was founded in 2018 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. The support and expertise of our parent organization has given AuroPackaging a jump start in building a solid pharmaceutical portfolio very quickly. AuroPackaging's aim is to provide healthcare at economical prices to make a healthier world to live in. Job Overview IPQA Associate Level II will support and assist activities related to the production of pharmaceutical products in accordance to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and batch record specification. The IPQA Associate shall assure compliance with all standards and regulatory guidelines. Responsibilities * Collaborates with other production staff and Departments. * Accurately and consistently completes and documents batch records/other required paperwork. * May provide on the job training and day to day guidance to other nonexempt personnel. Qualifications - Skills & Requirements * Good communication skills and capable of communicating with all levels * Be available for overtime, including weekends, as needed for production support. * A familiarity with cGMPS, CFRs, OSHA and FDA regulations. * Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits * Dental Benefits with three dental plan options through CIGNA * Vision Plan with two plan options through VSP * Life Insurance, Basic Life and AD&D and Supplemental Life Insurance * Disability Insurance, Voluntary Short-Term Disability and State Disability • Long-Term Disability (LTD), State (short term) disability - where applicable * FSA (Flexible Spending Accounts) - Both Health Care & Dependent Care Available * HSA (Health Savings Account) * 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years * Employee Assistance Program (EAP) - 100% Confidential and 100% company paid * Critical Illness and Accidental Insurance * Legal and Identity Theft Insurance * Paid Time Off - Paid vacation, PTO, Holiday Education & Experience * High School Diploma or equivalent GED. * Up to 4 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment. Compensation Min USD $24.00/Hr. Max USD $28.00/Hr. Physical Requirements WAREHOUSE OR PRODUCTION POSITION - While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. Additional Physical Requirements No Additional Requirements Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

Develop, implement and manage the company's compliance program for compliance with applicable laws and regulations relating to the sale of branded and generic pharmaceutical products. Managing the company's compliance with state and federal law program requirements (including Sunshine Act). Developing and delivering training on Aurobindo compliance policies and industry laws, regulations and guidance, managing investigations, participating in the promotional review processes, and providing guidance to employees on compliance and ethics matters. The Director, Healthcare Compliance will be expected to be able to bring to bear independent judgment in the conduct of investigations, the provision of guidance and advice to employees on compliance and matters, and interactions with senior management and vendors and other internal and external stakeholders.

The Senior Biostatistician is expected to have a thorough understanding of advanced statistical methods and develop an understanding of innovative statistical approaches (e.g., simulations, adaptive designs, Bayesian statistics). The Senior Biostatistician is also expected to have a thorough understanding of the DMC process and may assume the functional lead role within a designated DMC project team, involving facilitation of DMC meetings, awareness and active monitoring of project budgets, hours budgeted/spent, timelines, and will be actively contributing to systematic regular project status reviews. We offer structured peer mentoring and technical and management career development opportunities with exposure to clinical trials in many disease indications with a range of statistical methods across drugs, biologics, devices, and vaccines. + Develop and review input for DMC activities (charter, statistical analysis plan, mock shells, specifications, analysis, programming and validation, DMC meetings, meeting minutes). + Review and perform oversight of analysis plans, statistical analyses, outputs, and datasets provided by another vendor. + May serve as functional lead on DMC project teams. + Liaise with client/DMC for clarification on any technical decisions and propose most efficient, successful solutions. + Interact and coordinate with client staff and DMC members. + Participate in project team meetings and DMC meetings on a regular basis. + Provide statistical advice in project team setting. + Identify risks to project deliverables and timelines, develop and implement the mitigations for these risks. + Stays current regarding requirements to ensure quality control and audit readiness of all assigned biostatistics deliverables as well as accuracy and reliability of statistical analysis results. + Accurately review and report project forecasting and actual hours as scheduled per agreed scope for biostatistics tasks. + Understand and follow all relevant SOPs. + Understand and adhere to project specific clinical protocols. + Mentor Biostatisticians. + May coordinate activities of other personnel. + Master's degree or PhD in Biostatistics, Statistics, or related field. + With PhD, a minimum of 3 years of industry experience, with MS a minimum of 5 years of industry experience. + SAS programming skills; R a plus. + Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills. + Prior DMC experience required. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Description Accounts Payables Daily coordination with Global Shared Service based in India. Support shared service team in obtaining proper approvals, providing supporting documents, guiding relevant GL codes & Dept codes. Scanning the supporting documents and forward to shared service team. Cut checks and obtain signatories and mail checks to vendors Make sure shared service team is up to date AP accounting. Make sure no past due invoices of vendors and clean AP Ageing report. Review aged AP ageing report once in a week and follow up with shared service team for up to date. Reconcile AP Ageing Support Shared service team in expenses re-imbursements, on time payment to employees. Ensure payments are with in approved budget Accounts Receivables: Review chargebacks & rebates along with shared service team. Prompt Payment Discount reconciliation Sales returns coordination Medicaid Continuous monitoring of customer agreements. Coordinate with sales team, R&D and other teams in getting approvals and clarifications. Review aged AR ageing report once in a week and follow up with shared service team for up to date. Make sure shared service team is up to date AR accounting. Reconcile AR Ageing and reconcile balance with customers periodically Make sure no overdue invoices of customers and clean AR aging report Coordinate with sales team, R&D and other teams in getting approvals, clarifications and overdues General Ledger Accounting Reconciliations Budget vs Actuals Assist with GL Review Assist with month end closing Record, maintain, post and reversal of the monthly journal entries Maintain detailed listings of the contents of all balance sheet accounts Assist auditors with journal entry examinations Assist in the production of financial statements Provide supporting documentation for audits Management Accounting Assist in preparation monthly MIS reports for internal management Assist in quarterly and annual financial statements and audits Assisting Operations team in the Monthly Operations Review, identification of areas for cost reductions and operational improvements, annual budget process, periodic forecasting, and periodic analysis of operations performance. Perform all other duties as assigned and required. Effective Coordination with President, Sales administration, QA and regulatory departments and support them in providing the relevant information. Skills BA with 7 plus years accounting experience/CA with 3-5 years of experience Experience with Oracle (preferred) Advanced Excel skills (must), ability to work with lookups and pivot tables. Proficiency in Microsoft Word, Outlook and PowerPoint. Self-motivation Responsible Organizational skills and ability to manage deadlines Analytical ability, a methodical approach and problem solving skills Numeracy and detailed oriented

We are seeking an Executive Consultant - Vice President of Quantitative Clinical Pharmacology to join our Strategic Consulting team. This role blends scientific leadership, strategic advisory, client relationship development, and technical excellence in population modeling and quantitative clinical pharmacology. The successful candidate will leverage both deep quantitative expertise and strong business acumen to expand Cytel's thought leadership, drive complex consulting engagements, and guide clients in shaping optimal regulatory and clinical development pathways. **Strategic Consulting & Thought Leadership** + Serve as an externally recognized expert in Quantitative Clinical Pharmacology, Pop-PK/PK-PD modeling, MIDD, and quantitative regulatory strategies. + Lead the development and dissemination of innovative methodologies, contributing to Cytel's scientific leadership through publications, conference presentations, and webinars. + Provide high-level strategic guidance to clients on clinical development plans, regulatory and market access pathways, trial design optimization, and quantitative decision-making. **Client Engagement & Business Development** + Act as the primary point of contact for major Strategic Consulting accounts, ensuring delivery excellence and long-term partnership development. + Identify and pursue new business opportunities across Cytel's consulting and analytics offerings, shaping solutions that meet revenue, profitability, and client satisfaction objectives. + Build and maintain relationships with senior stakeholders, including regulatory agencies (e.g., FDA, EMA), key opinion leaders, and executive-level client personnel. **Scientific & Analytical Leadership** + Oversee and contribute to Pop-PK and PK/PD modeling, non-compartmental analysis (NCA), and broader QPP analytical activities. + Provide mentorship, technical oversight, and direction to consultants and analysts, building a high-performing quantitative team. + Support non-QPP engagements when needed, such as statistical design, adaptive/Bayesian methodologies, simulation-based planning, or data science initiatives. **Cross-Functional Collaboration** + Work closely with Cytel's business developers, statisticians, software teams, and data scientists to deliver integrated, high-value solutions. + Represent QPP expertise within multidisciplinary engagements, ensuring strategic alignment and scientific rigor. + Travel as required to engage with clients and internal stakeholders. **Experience** + Minimum 5+ years of hands-on QPP experience; 15+ years overall experience in consulting, clinical development, or health research preferred for VP-level responsibilities. + Demonstrated leadership in MIDD, Pop-PK/PK-PD modeling, and quantitative strategy within drug development. + Experience interacting with regulatory authorities and contributing to regulatory submissions is highly desirable. **Required Technical & Professional Skills** + Proven expertise in Pop-PK/PK-PD modeling, NCA, and interpretation of quantitative pharmacology results for CSR and reporting. + Proficiency in Phoenix WinNonlin/NLME, R, and strong understanding of computational and statistical methods used in clinical development. + Excellent technical writing, oral communication, and presentation skills; ability to clearly communicate complex quantitative concepts. + Strong organizational, analytical, and problem-solving abilities; able to operate effectively in a fast-paced, high-growth environment. \#LI-KO1 Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

** **At Dr. Reddy's "Good Health Can't Wait"** By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. **Diversity, Equity & Inclusion** At Dr. Reddy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. **Job Description** We are seeking an exceptional leader to Head Pharmacovigilance and Medical Affairs including medical information function for Dr. Reddy's North America Generics and affiliates as well as Dr. Reddy's Canada. Incumbent will drive Medical Affairs strategies and be responsible for accurate patient safety data. Provide oversight on medical information services and support in providing strategic inputs to cross functional teams as well as initiate, improve and monitor the execution of existing systems. **Responsibilities:** + Manage, create (vendor) and review ICSR (US/Foreign), PSR reports from clinical and medical standpoint, identify and respond to signal analysis, and submit to regulatory agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US (FDA regulatory agencies),participate in audits and provide support in external audits. Responsible for driving successful PV audits to achieve no critical findings and provide post inspection report with corrective action plan + Identify pharmacovigilance processes and procedures to be documented and set up. Establish the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + Review current reporting period against historical data to conduct detail evaluation of risks / identify potential risk areas. Review existing products for safety risks and generate report on product risk-benefit ratio and develop proposal for regulatory agencies and manage the REMS program, budget and ensure regulatory sign off and take corrective actions when necessary + Support in the development and execution of North America Medical Affairs plans and Dr. Reddy's Canada Medical Affairs plans in consideration of best clinical practices and overall corporate objectives aligned with commercial Brand strategy + Provide oversight of the medical information services for North America and ensure seamless communication with Pharmacovigilance service providers + Engage effectively cross-functionally, maximizing functional reporting relationships, and ensure successful implementation of company strategies. Support scientific congress attendance via pre-meeting planning and post-meeting CI reporting + Support global Pharmacovigilance digitalization efforts to increase efficiency, quality & productivity while ensuring that the deliverables are 21CFR Part 11, GAMP 5 and GxP compliant _Incumbent should be willing to work in person from our Princeton, NJ office_ **Qualifications** **Educational qualification:** Advanced scientific degree (MD, PhD, Pharm.D. or other) **Minimum work experience:** 10+ years in PV & Medical Affairs in the pharmaceutical industry **Skills & attributes:** + Understanding of North American pre-and post-marketing regulatory requirements for medical Affairs and Medical Information activities. + Knowledge of FDA and Health Canada: Drug Discovery and Development Processes; Clinical Development Tools and Processes; Medical Affairs Guidelines; Regulatory Guidelines; Pharmacovigilance Guidelines; Domains across the pharma value chain + A collaborative team player with ability to work successfully across teams and functions + Proactiveness with attention to detail + Excellent communication skills (verbal & written); MS Office suite + Demonstrated ability to manage various projects, solve problems, deliver on commitments, and work with multidisciplinary teams **Additional Information** Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring visa transfer or sponsorship, now or in the future. Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process. **Our Work Culture** Ask any employee at Dr. Reddy's why they come to work every day and they'll say, because Good Health Can't Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we're always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. **Equal Opportunity Employer** An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. For more details, please visit our career website at ********************************

Lead and fully execute the accounting operations in Colombia, ensuring compliance with regulatory, tax, and corporate requirements, within a context of sustained financial growth over the next three years. Key Responsibilities * Manage all accounting activities in Colombia, including monthly, quarterly, and annual closings. * Ensure compliance with Colombian accounting and tax regulations, with a strong focus on taxation. * Coordinate and work directly with international teams (India), aligning processes and financial reporting. * Actively participate in financial planning and support the projected business growth. * Ensure proper execution of import and export processes, when applicable. * Administer and optimize accounting processes in SAP S/4HANA. * Handle internal and external audits. Requirements * Degree in Public Accounting. * Proven experience as Chief Accountant or similar role, with team leadership (mandatory). * Preferably experience in the pharmaceutical industry; alternatively in FMCG, import and export. * Strong knowledge of Colombian tax and fiscal regulations. * Advanced English (mandatory), with the ability to interact fluently with teams in India. * Advanced proficiency in SAP S/4HANA (CP1). * Strong leadership, communication skills, and ability to work in multicultural environments.

Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines. Eugia's mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia's capabilities to include the manufacture of highly complex injectables to answer that need. Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals. Job Overview We are seeking a detail-oriented and proactive Accounts Receivable Manager to lead our receivables operations and support broader finance functions. This role is primarily focused on Accounts Receivable, with additional responsibilities spanning management accounting, inventory oversight, accounts payable coordination, and tax support. The ideal candidate will bring strong analytical skills, deep understanding of pharma-specific claims and pricing structures, and the ability to drive process improvements across the finance function. This position is located onsite at the East Windsor, New Jersey location, reporting to the Director of Finance. Responsibilities Accounts Receivables * Review high level claims like chargebacks, failure to supply, shortages, rebates, Medicaid, sales returns etc. and Interact with customers for several matters * Ensure timely collection from customers & reconcile key customer accounts * Periodic review of contract prices and impact analysis * Continuous review of processes and identification of areas of improvement Management Accounting * Prepares and reports monthly MIS reports for internal management * Identification of areas for cost reductions and operational improvements, annual budget process, periodic forecasting, and periodic analysis of operations performance Inventory Management * Conduct regular audits to verify accuracy of inventory records, investigate discrepancies, and implement corrective actions * Assist the auditors and corporate team in physical verification of inventory * Identify slow-moving or obsolete items, and make recommendations for inventory optimization Accounts Payables * Support shared service team in expenses re-imbursements and other payments, on time payment * Coordination with cross function departments to support them in providing the relevant information * File Form 1099 Tax & regulatory * Coordinating with the tax team for timely tax payments and filing of the tax returns/ information, submissions of replies toward tax notices This is not an exhaustive list of all responsibilities, duties, skills, efforts, or requirements associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice. Qualifications - Skills & Requirements * Experience with Oracle (preferred) * Knowledge and experience within Finance in the Pharmaceutical industry is required * Advanced Excel skills required - ability to work with lookups and pivot tables along with Proficiency in Microsoft Word, Outlook and PowerPoint * Self- motivated and Desire to learn * Organizational skills and ability to manage deadlines * Analytical ability, a methodical approach and problem-solving skills Education & Experience * Bachelor's or Master's degree in Finance, Accounting, or a related field * Minimum of 5 years of progressive accounting experience, with at least 3 years focused on Accounts Receivable within in the pharmaceutical industry The annual base salary range for this position goes up to $100,000.00 annually, depending on factors such as experience level, knowledge, skills, and abilities. Final compensation decisions will consider these and other relevant business needs. In addition to base salary, this position is eligible for an annual bonus, with target percentages varying by role. The total compensation package may also include discretionary incentives and role-based monthly allowances (e.g., cell phone or car allowance, where applicable). Health and Welfare Offerings: * Medical Insurance: Choice of four Horizon Blue Cross Blue Shield of New Jersey plans - PPO, EPO, HDHP, and OMNIA. Premiums and coverage vary by plan. * Prescription Coverage: Included with medical insurance; tiered copays based on medication type. * Dental Insurance: Choice of three plans - DHMO, Core PPO, or Buy Up PPO plans. * Vision Insurance: Choice of two plans - Base and Buy Up options. * Life and AD&D Insurance: Company-paid Basic Life and AD&D (1x annual salary up to a specified maximum), with optional Supplemental coverage. * Disability Insurance: Voluntary Short-Term Disability (employee-paid); Long-Term Disability is company-paid. * Flexible Spending Accounts (FSAs): Available for health care and dependent care expenses. * Health Savings Account (HSA): Offered with HDHP enrollment; employee-funded. * Voluntary Benefits: Identity Theft Protection, Critical Illness Insurance, Accident Insurance, and Legal Insurance (all employee-paid). * Employee Assistance Program (EAP): Confidential support services at no cost. * 401(k) Retirement Plan: Pre-tax and Roth contribution options available, with company match; vesting applies. * Paid Time Off: Includes vacation, PTO, and company holidays (varies by role and tenure). * Employee Referral Program: $1,000 bonus for each qualified hire you refer. Physical Requirements OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Additional Physical Requirements No Additional Requirements Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.