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Zydus Pharmaceuticals jobs - 96 jobs

  • IT Business Analyst

    Zydus Pharmaceuticals USA 4.3company rating

    Zydus Pharmaceuticals USA job in Pennington, NJ

    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
    $140k-160k yearly 60d+ ago
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  • Summer Intern- Legal and Communications

    Zydus Pharmaceuticals 4.3company rating

    Zydus Pharmaceuticals job in Pennington, NJ

    Job DescriptionZydus Pharmaceuticals (USA) Inc. is seeking a summer intern interested in joining our Marketing and Legal teams in Pennington, NJ. The intern will have an opportunity to learn about the generics industry, critically think about corporate communications, draft materials, and participate in other ad hoc projects. 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. RESPONSIBILITIES:• Assist in building out a guide for corporate communications• Assist in the development of content for Zydus' social media sites and company intranet• Research social media pages of key competitors• Edit and draft company communications for both internal and external use• Assist in performing third party due diligence of vendors• Provide assistance on presentations/trainings for employees on various legal issues• Review customer master list to ensure all key terms and new contracts are captured • Ad hoc projects as required QUALIFICATIONS - SKILLS & REQUIREMENTS:• Excellent communication skills• Interest in corporate communications • Ability to think critically with a legal mindset• Ability to work both independently and in a team environment• Knowledge in SharePoint a plus• Must be legally authorized to work in the United States without restriction• Must be 18 years of age or older EDUCATION & EXPERIENCE:• College graduate with 1st year of law school completed TRAVEL: • NoneWORK 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.
    $49k-72k yearly est. 6d ago
  • Vice President, Head of Global Market Access

    Sun Pharmaceutical Industries, Inc. 4.6company rating

    Princeton, NJ job

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Title: Vice President, Head of Global Market Access Company: Sun Pharmaceutical Industries, Inc (USA) Vice President, Head of Global Market Access Job summary Sun Pharmaceuticals is looking for a dynamic, experienced, and motivated Head of Global Market Access. As a leader in the organization, this role will be responsible for developing and executing Market Access strategies to demonstrate the value proposition of Sun Pharma's products to Global payer systems with specific focus on US, Europe and Japan. This individual will lead pre-launch and launch strategic planning and execution to optimize market access and reimbursement on a global scale. This individual will work in conjunction with the global and country cross functional teams, as well as other internal and external stakeholders, to ensure patients have access to Sun's medicines. Duties and responsibilities Lead the Development and Implementation of Innovative Access Strategies : Lead the development and execution of state-of-the-art, innovative, and comprehensive Market Access and pricing strategies for both launched and development compounds. Lead a Culture of Innovation : Guide cross-functional teams in pioneering Real-World Evidence strategies and initiatives. Lead in Advanced Research : Design and oversee the execution of cutting-edge health economic models (cost-effectiveness, budget impact, etc.), systematic literature reviews, and both retrospective and prospective observational studies, leveraging the latest methodologies and technology. Lead through Strategic Guidance : Monitor and interpret healthcare policy and payer environments, providing strategic guidance to the company to anticipate and adapt to potential impacts. Lead through Internal Collaboration : Forge strong collaborations with clinical development, medical affairs, and regulatory teams to ensure seamless integration of Access strategies into overall product development and market access plans Lead in External Agency Management : Provide hands-on oversight and guidance on Market Access and pricing related agency selection and management, ensuring the highest quality of collaborations at proper cost. Lead in Integrity : Ensure the scientific integrity of all Market Access projects, and lead publications of data in peer-reviewed journals and conferences. Lead in Impacting Stakeholders : Engage proactively with external stakeholders, including academic experts, healthcare providers, and payers, to champion the value of our products and drive transformative changes in healthcare practices. Education and Qualifications This position requires a minimum of an advanced degree; PhD or Master's degree in Business, Economics, Epidemiology, Public Health, Pharmacy or related field. A strong understanding of the global payer environment, including health technology assessment (HTA) processes in key markets is required. Experience This position requires a minimum of 15 years of experience in Market Access/Pricing function, preferably with experience in innovative medicines Demonstrated ability to work independently as a Market Access leader within a biotech/pharma organization. Disease area experience in dermatology, autoimmune disease, ophthalmology, or oncology is preferred. Track record of successful payer and health technology engagement leading to documented examples of rapid and expanded patient access. Excellent leadership skills with a proven track record in managing high-performing teams. Strong communication skills with the ability to explain complex concepts to a variety of audiences. Display a demonstrated ability to think strategically and implement research strategies across a broad portfolio, setting Sun Pharma apart as a thought leader in the industry. The presently-anticipated base compensation pay range for this position is $280,500 to $342,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. The preceding has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s). Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. Notice to Agency and Search Firm Representatives: Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. #J-18808-Ljbffr
    $280.5k-342.5k yearly 5d ago
  • Manager - Engineering & Maintenance

    Biocon 4.3company rating

    Cranbury, NJ job

    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.
    $88k-119k yearly est. 3d ago
  • Inspection and Packaging Technician I

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary: 1st Shirt 6:30AM-2:30PM** Assist in visually inspecting, labeling and packaging pharmaceutical products. **Area Of Responsibility:** + Assists in performing visual inspections, labeling, assembling and packaging of liquids, suspensions, and lyophilized pharmaceutical and dermatological products in vials, ampoules etc. + Cleans up labeling and packaging assembly equipment and facility as needed + Comply with all policies and procedures related to personal safety and job area safety + Maintains manufacturing records and completes all required paperwork/documents to comply with Federal Regulations and FDA + Reports variance or deviations from standard procedures to department management + Stocks materials utilized by the department + Operates semi-automatic inspection machine, vial label applicator and box imprinting machines + Other duties as assigned **Work Conditions:** + Controlled unclassified manufacturing/production area + Warehouse office + Possible exposure to hazardous and non-hazardous chemicals **Physical Requirements:** + Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, talk and hear + Use of repetitive motion, unimpaired manual dexterity + Close vision, color vision, peripheral vision, depth perception, ability to focus + Correctable 20/20 vision + Ability to visually inspect small products and print + Be able to sit at workstation for up to 50 minutes at a sitting for up to 8 hours per day + Requires use of appropriate personal protective equipment (lab coat, hairnet, booties, and gloves) + Lifts up to 35lbs. **Travel Estimate:** Up to 0% **Education and Job Qualification:** + High School Diploma or GED required + Biotechnology certificate preferred or equivalent experience + Ability to visually inspect small print/printed labels + Ability to visually inspect liquid and lyophilized pharmaceutical products for small particles + Ability to read, write and follow written and verbal instructions/procedures in English + Ability to work independently or in a group setting **Experience:** + Minimum 0-2 years related experience + Familiarity with, and the ability to follow established Standard Operating Procedures (SOPs), Master Batch Records, and adhere consistently to current Good Manufacturing Practices (cGMPs) + Works under direct guidance of the supervisor + Basic math skills + Basic computer skills **_Disclaimer:_** _The preceding has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._ _The presently-anticipated base compensation pay range for this position is $20.00/hr to $25.00/hr.The presently-anticipated base compensation pay range for this position is $20.00/hr to $25.00/hr. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $20-25 hourly 33d ago
  • QC Compliance Specialist

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary:** Under limited supervision, manages laboratory compliance activities for assigned functions and projects. Investigates method performance, reliability and improvement issues, and evaluates proposed changes to compendial or in-house methods. Prepare and review the technical and compliance documents such as analytical methods, specifications, Method Validation/Transfer Protocols and Reports, SOPs accordingly to companys standards and FDA /ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. To review the USP and other compendia changes on a timely basis and update the related documents to implement the changes and ensure the compliance. **Area Of Responsibility:** + Writes technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies and SOP's, compendial, ICH and FDA regulatory guidance. + Ensures that the integrity and accuracy of all laboratory documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations. + Evaluates compendial documents, and reviews procedures for laboratory compliance. + Evaluate Sun global documents (GQS and GSOP) against site specific procedures and update the site procedure accordingly. + Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards. + Generates change requests required for analytical documents, and routes documents for review and approval. Maintains hard copies and electronic file of technical documents. + Timely provide the QC documents required for CBE, PAS and ANDA submission to RA. + Collaborates with colleagues and external partners to achieve individual and department goals. + Ensure compliance with cGMPs, DEA regulations and site operating procedures under the direction of QC Management. + Ensure Lab Event/Out-of-Specification and Out-of-Trend investigations are properly conducted and closed on a timely fashion. + Ensure continuous laboratory compliance by adopting best industry practice and complying with procedure requirements. **Work Conditions:** Manufacturing/Production environment Environmental related to manufacturing/production environments: + Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing. + Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction. + Odors: Unpleasant smells. + Gases: Examples include carbon monoxide and ozone. + Dust: Airborne particles of any kind, such as textile dust, wood, and silica. Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock. **Physical Requirements:** + Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl. + Close vision; depth perception; ability to adjust focus + Use of repetitive motion + Able to operate computer/office machines + Able to lift and carry up to 50 lbs. **Travel Estimate:** Up to 5% **Education and Job Qualification:** + Minimum BS or equivalent degree in Chemistry or related discipline. + Good computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access. + Must have an understanding of FDA guidelines, ICH guidance and DEA regulations. Ensures compliance with cGMPs, DEA regulations, safety and site operating procedures under the direction of Management. + Must have LIMS and SAP knowledge. + Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills. + Must have cGMP compliance knowledge and experience. + Collaborates with colleagues and external partners to achieve primary Department goals. + Works in coordination with project plans and goals as assigned by Management. + Demonstrated strong communication: verbal, written and presentation skills. + A self-starter with a hands-on approach and a can-do attitude. + Excellent project management and problem solving skills. + The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR). **Experience:** + Minimum of four (3) years of experience in the pharmaceutical industry preferred. **_Disclaimer:_** _The preceding has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._ _The presently-anticipated base compensation pay range for this position is $75,500 to $83,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $75.5k-83k yearly 60d+ ago
  • DEA Compliance Data Review Associate

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Join Sun Pharma and make an impact in ensuring compliance and safety in pharmaceutical manufacturing!** We are looking for a detail-oriented and proactive **DEA Compliance Data Review Associate** to support our Controlled Substance (CS) programs and Good Manufacturing Practices (GMP). This role is critical in maintaining compliance with DEA regulations and Sun Pharma standards. **What Youll Do** + Manage and operate Controlled Substance Vaults and Cages across facilities. + Maintain accurate daily records and organize products in secure storage areas. + Reconcile API and batch records for controlled substances and List I chemicals using Excel. + Track movement of controlled substances through production phases and third-party vendors. + Assist in generating year-end DEA reports and conduct periodic audits for compliance. + Investigate and report non-compliance issues, taking corrective actions. + Support DEA agents during onsite inspections. + Monitor material accountability during manufacturing, packaging, and testing. + Perform Year-End, Biennial, and Biannual inventories of controlled substances. + Document controlled substance waste and verify SAP entries. **What Were Looking For** + **Education:** High School Diploma required. + **Experience:** + Minimum 1-2 years in a pharmaceutical manufacturing environment (4 years preferred). + At least 1 year of DEA-related experience preferred. + Experience in warehouse operations and inventory management is a plus. + **Skills:** + Knowledge of 21 CFR 13001301 regulations preferred. + Proficiency in Microsoft Office (Excel required); SAP experience is a plus. + Strong organizational, analytical, and problem-solving skills. + Excellent verbal and written communication. + Self-starter with a hands-on, can-do attitude. + **Language:** English proficiency at CEFR B1+ level. **Physical & Work Environment** + Ability to lift up to 50 lbs. + Exposure to manufacturing environments (noise, fumes, odors, dust). + Office work combined with production/warehouse facility presence. **Schedule:** 2nd Shift, Monday-Friday 3:00pm - 11:30pm **Why Join Sun Pharma?** At Sun Pharma, youll be part of a global leader committed to quality, compliance, and innovation. We offer competitive benefits, growth opportunities, and a collaborative work culture where your contributions truly matter. **Ready to make a difference? Apply today and help us uphold the highest standards in pharmaceutical compliance!** _The presently-anticipated base compensation pay range for this position is $74,500 to $87,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $74.5k-87.5k yearly 9d ago
  • Metrologist III

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. We are seeking a skilled and detail-oriented **Metrologist III** to join our dynamic team. This role is critical to ensuring the accuracy, reliability, and compliance of our laboratory instrumentation in support of high-quality pharmaceutical operations. **Key Responsibilities:** + Preparation of master Preventive Maintenance/Calibration schedule. + Planning, execution and review of instrument calibration/qualification related activities as per the calibration master plan. + Draft and review of instrument operation, maintenance and calibration procedures. + Initiate change controls for new and existing instrument and its procedures. + Concurrent documentation of all the raw data, observations in the notebook or applicable documents. + Notify to the supervisor any anomalous or OOC results. Notify the management for any observations or deviations. + Adhere to cGMP and safety procedures. + Review and report any applicable calibration/qualification documents. + Logging and attending instrument repair requests. + Scheduling visit for outside contractors for preventive maintenance or repair. + Placing out of service tag on instrument due for calibration, instrument requiring a repair or on a new instrument. + Opening the investigations and conduct primary investigation under direct guidance from management. + Ensure adequate labeling of all instruments and ensure instrument calibration status. + Order and maintain spare parts for major instrument to ensure continuous support of the analysis. + Verify the expiry date of chemicals, reagents, primary calibrators prior to use. **Education and Job Qualification** + **Bachelors degree** in Chemistry or related discipline (required) + Minimum **4 years of experience** in a pharmaceutical laboratory setting + Strong knowledge of **analytical instruments** (HPLC, GC, FTIR, UV) + Familiarity with **cGMP/GLP** , **ICH** , and **FDA** regulatory guidelines + Proficient in **instrument troubleshooting** and problem-solving + Excellent **written and verbal communication** skills + A self-starter with a hands-on approach and a can-do attitude. + The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR). + Comfortable using **Microsoft Office** applications **Work Environment & Physical Requirements:** Manufacturing/Production/Laboratory environment Environmental related to manufacturing/production/laboratory environments: + Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing. + Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction. + Odors: Unpleasant smells. + Gases: Examples include carbon monoxide and helium. + Dust: Airborne particles of any kind, such as textile dust, wood, and silica. + Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock. + Able to lift and carry up to 50 lbs. + While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle objects, or feel objects, tools, or controls; and reach with hands and arms. + The employee is occasionally required to stand, stoop, kneel and crouch. + Specific vision abilities required of this job include close vision, distance vision, color vision and the ability to adjust focus. **Travel Requirement:** Up to **5%** _The presently-anticipated base compensation pay range for this position is $74,500 to $82,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $74.5k-82.5k yearly 60d+ ago
  • Patent Paralegal, Princeton, NJ - Hybrid

    Sun Pharmaceuticals, Inc. 4.6company rating

    Remote or Princeton, NJ job

    Sun Pharmaceuticals Industries Inc. is the fourth largest generic pharmaceutical company in the world, and rapidly building our brand presence. We manufacture, market and distribute pharmaceuticals to the nations largest wholesalers, distributors, warehousing and non-warehousing chain drugstores as well as managed care providers. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately the patient. Current manufacturing capabilities allow Sun Pharma to develop products across most therapeutic categories. At Sun Pharma we believe our people are an invaluable asset. Our culturally diverse workforce is one of our biggest strengths, along with the rich experience they bring across varied skill-sets. We are proud that our global workforce is bound by our common values. **Job Summary:** Sun Pharma is seeking a highly capable detail-oriented and proactive Patent Paralegal to join our dynamic IP team in Princeton. This position supports the Director, Intellectual Property, and local and global IP Department in all matters relating to the coordination and maintenance of the Companys global intellectual property portfolio. In this role, your duties will include docketing of U.S. and foreign patent matters, preparing and filing patent office submissions, including related formality documents, researching patent databases, and monitoring the filing status of patents. To ensure success as a Patent Paralegal, you should possess knowledge of a strong understanding of IP law and procedures, excellent organizational skills, and the ability to collaborate effectively with internal and external stakeholders. An outstanding patent paralegal will be a team player whose resourcefulness translates into excellent support to the department. **Responsibilities** : + Collaborating with the USPTO, internal and external attorneys, liaisons, foreign associates, and staff. + Extracting relevant IP information from official USPTO databases and correspondence. + Generating docket reports, performing IP docketing, and tracking and de-docketing deadlines and reminders. + Entering new U.S. Provisional, Continuation, Utility, Design, CIP, Opposition, Divisional, and re-examination files into databases. + Assisting attorneys with patent filing by resolving discrepancies, errors, and omissions. + Maintaining IP records and reviewing files. + Performing IP research on public and private databases. + Processing incoming and outgoing correspondence. + Processing of annuity payments **Education/Qualifications:** + An undergraduate college degree, paralegal certification or equivalent work experience. + State-approved accredited paralegal certification. + A minimum of 5-7 years of experience in patent docketing and prosecution administration. + Proficiency in legal terminology and electronic databases, including the USPTO's PAIR. + Experience in managing IP records and generating docket reports. + Extensive knowledge of patent filing and review. + Exceptional ability to perform research and keep track of deadlines. + Ability to collaborate with others and work independently. + Exceptional recordkeeping and communication skills. The presently-anticipated base compensation pay range for this position is $107,000 to $130,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. Notice to Agency and Search Firm Representatives: Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $107k-130.5k yearly 10d ago
  • Summer Intern- Pricing and Analytics

    Zydus Pharmaceuticals 4.3company rating

    Zydus Pharmaceuticals job in Pennington, NJ

    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.
    $36k-48k yearly est. 6d ago
  • Raw Material Dispensing Operator I

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary** We are looking for a detail-oriented and safety-focused **Raw Material Dispensing Operator** to support raw material dispensing and warehouse operations in a pharmaceutical manufacturing environment. This entry-level role is ideal for individuals who are eager to learn and grow within a regulated industry. The successful candidate will follow strict procedures to ensure compliance with cGMP standards and contribute to a clean, organized, and efficient workspace. **Key Responsibilities** + Dispense raw materials according to Process Order Records and Standard Operating Procedures (SOPs). + Perform calculations for API and filler quantities as required per Batch Card. + Follow proper documentation practices and detect/correct errors. + Stage raw and dispensed materials in designated areas. + Conduct daily scale standardizations. + Execute cleaning procedures as outlined in SOPs. + Maintain compliance with cGMP, safety, and health regulations. + Adhere to gowning procedures and environmental condition requirements. + Keep work areas clean, organized, and stocked with necessary supplies. + Promptly complete tasks assigned by Team Lead or Supervisor. + Report any discrepancies or anomalies in the dispensing area. **Work Conditions** This role is based in a **manufacturing, production, and warehouse environment** and may involve exposure to: + **Noise** : Constant or intermittent, potentially distracting. + **Fumes, gases, and odors** : From chemical reactions or combustion. + **Dust** : Airborne particles from various materials. **Physical Requirements** + Regular use of hands, hearing, and speech. + Frequent standing, walking, sitting, bending, kneeling, crawling, pushing, and reaching. + Ability to lift and carry 5075 pounds. + Ability to move pallets/equipment weighing 100300 pounds using pallet jacks or Hi-Lo. + Must wear appropriate personal protective equipment (PPE), including respirators, safety glasses/goggles, and safety shoes. **Schedule:** + 2nd Shift: Monday - Friday, 3:00am - 11:30pm. + Flexibility for overtime may be required. **Qualifications** + High School, Trade School, or Vocational School Diploma, GED, or equivalent. + Basic understanding of cGMP and pharmaceutical regulatory requirements. + Familiarity with Occupational Health & Safety procedures. + Basic math and computer skills, including MS Office and SAP. + Good interpersonal and communication skills. + Strong attention to detail and problem-solving abilities. + English proficiency at **Basic A2 level** (CEFR). **Experience** + Entry-level position; **no prior experience required** . + Fork truck operation experience is a plus. _The presently-anticipated base compensation pay range for this position is $21.84/hr. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $21.8 hourly 11d ago
  • Lab Technician (3rd Shift)

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology **Job Summary** Are you passionate about chemistry and quality assurance? Join our dynamic team as a **Lab Technician** , where you'll play a key role in ensuring the integrity and safety of our chemical and Active Pharmaceutical Ingredient (API) products. This is a great opportunity for detail-oriented professionals who thrive in a fast-paced, regulated environment and are looking to grow their careers in the pharmaceutical or chemical industry. **Schedule** + **Days:** Sunday Night - Friday Morning **or** Monday Night - Saturday Morning + **Hours:** 11:00PM 8:00AM **Key Responsibilities** + Perform chemical and API sampling analysis using established, validated methods. + Accurately document test results, maintain logs for analyses, samples, and time studies. + Adhere strictly to all safety protocols and standard operating procedures (SOPs). + Participate in training and become certified on all required analytical methods. + Support the team with additional duties as needed to ensure smooth lab operations. **Qualifications** + Associates or Bachelor of Science in Chemistry or a related scientific field. + Empower experience preferred. + Hands-on experience with basic wet chemistry techniques (e.g., pipetting, weighing, titration). + Proficiency with Microsoft 365 applications. + Strong attention to detail and ability to follow precise instructions. + Flexibility to work any shift, with this role specifically assigned to 3rd shift. _The presently-anticipated base compensation pay range for this position is $20.00/hr to $24.00/hr. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $20-24 hourly 60d+ ago
  • Senior Associate, Quality Compliance

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary:** The Quality Assurance Specialist is responsible for the batch certification review of site QA activities related to manufacturing and packaging records, as well as all supporting documentation. This includes ensuring compliance with Standard Operating Procedures (SOPs), equipment and instrument maintenance, calibration, qualification, and validation in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and ALCOA++ principles. The role also provides support during regulatory, corporate, and internal audits. **Key Responsibilities** + Support batch certification activities for commercial distribution in the USA and Canada, ensuring timely execution aligned with production schedules and deliverables. + Serve as a subject matter expert in sterile manufacturing and packaging processes. + Review investigations related to site incidents and deviations (planned/unplanned, FARs), ensuring corrective and preventive actions are appropriate and effective. + Ensure compliance with regulatory requirements for product, process, equipment, and release procedures. + Provide support during regulatory audits, internal and external inspections, and corporate audits. Responsible for follow-up on operational findings from FDA and other regulatory bodies. + Participate in and conduct mock inspections to prepare the facility for audits; assess system gaps and review documentation for compliance with current regulations and cGMP standards. + Identify compliance issues and support implementation of continuous improvement initiatives. + Promote adherence to SOPs and policies, ensuring procedures reflect current practices. + Perform additional assignments as required. **Work Conditions** + Corporate office environment + Manufacturing and production areas + Laboratory settings + Warehouse environment + Field familiarity as needed **Physical Requirements** + Ability to bend, lift, move, and carry items up to approximately 10 pounds. + Capable of navigating office, lab, and plant floor environments; standing, walking, and reaching as needed. + Must be able to wear required personal protective equipment (PPE), including respirators, safety glasses/goggles, and safety shoes. **Travel Requirements** + Up to 30% **Qualifications** **Education:** + Minimum of a Bachelor's degree required. + Participation in seminars and training courses is considered an asset. **Skills & Competencies:** + Strong understanding of cGMPs, particularly those related to documentation practices. + Ability to work effectively within an international, multicultural matrix organization. + Proficiency in software applications including MS Word, Excel, PowerPoint, Outlook, Acrobat Reader, TrackWise, LMS, and other relevant systems. + Knowledge of project management principles and tools. + Excellent communication, interpersonal, and organizational skills. **Experience** + Minimum of 7 years of experience in the pharmaceutical industry. + Experience working in a global, multicultural matrix organization. _The presently-anticipated base compensation pay range for this position is $90,000 to $112,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $90k-112.5k yearly 60d+ ago
  • Chemist, R&D Analytical

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    1. Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals. 2. Maintain detailed and comprehensive documentation of all work performed. 3. Stay current with the scientific literature, particularly in areas that may affect companys product line, existing processes or potential commercial opportunities. 4. Evaluate technology packages from external sources for chemical and cost-effective viability, as directed. 5. Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety. 6. Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis. 7. Provide support to QA/QC by writing analytical SOPs. 8. Communicate results by providing timely reports and project updates, to include technical reports and summaries for company business units and customers. 9. Provide monthly report on progress of work to the department head. 10. Provide help on preparation of quarterly/yearly R&D summaries of ongoing work to peers and senior management. 11. Plan and develop robust analytical methods including troubleshooting and validation, as appropriate. 12. Work closely with Synthesis group and support on routine analysis. 13. Work closely with Quality Assurance (QA) and Quality Control (QC) to identify project needs and to insure strict compliance with internal quality and/or cGMP/ICH guidelines. 14. Work closely with QA on validation efforts for new API processes to insure strict cGMP compliance, where appropriate. 15. Work closely with R&D team to answer DMF deficiencies and customer queries. 16. Maintain rigorous accountability and documentation of work related to controlled substances in accordance with established SOPs and requirements of federal regulations (21 CFR Part 1300-1399). 17. Adhere to all relevant company SOPs and guidelines, and provide input for correcting and changing existing procedures and processes. 18. Provide technical support as needed for company products, analytical methods and customer-driven issues, as needed. 19. Provide necessary information on cost-saving and time-saving alternatives to current analytical and laboratory practices whenever and wherever possible. 20. Assist in supervision of R&D laboratory operations in general, including troubleshooting of lab systems and instrumentation. 21. Work with Health, Safety and Environmental representative to identify waste stream data and possible hazards for potential products and processes. 22. Assist in the maintenance and cleaning of the R&D laboratory in general and in individual workspace in particular. 23. Seek out opportunities for professional development. 24. Select and purchase R&D chemicals, glassware and supplies, and track these orders using the established R&D purchase requisition system. 25. Execute R&D stability program, to include writing and following stability protocols, and packaging and testing APIs, as well as compiling and reporting stability results to R&D manager. 26. Facilitate the training system within the R&D department in coordination with the requirements set forth by QA. 27. Other duties as assigned. **Position Requirements:** + B.S. degree in Chemistry (preferable), Chemical Engineering, or related discipline. + Ability and attitude to assume a leadership role and work in a productive technical team within an industrial research environment. + Ability to communicate effectively through verbal, written, presentation and computer modes of expression. + Ability to confidently represent company on technical matters to customers, senior management, and at scientific venues (conferences and publications). _The presently-anticipated base compensation pay range for this position is $102,500 to $125,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $102.5k-125k yearly 60d+ ago
  • Manager Supply Chain

    Sun Pharmaceutical Industries 4.6company rating

    New Brunswick, NJ job

    Sun Pharma is the world's fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. Summary: This is an exciting opportunity for a seasoned supply chain professional to take a strategic leadership role in a dynamic pharmaceutical environment. As the Supply Chain Planning Manager, you will be at the forefront of ensuring product availability by aligning market demand with manufacturing capabilities across internal and external sites. You'll lead a team of planners, collaborate cross-functionally, and drive continuous improvement in supply performance. This role offers significant visibility and impact, with opportunities to influence executive-level planning, manage high-priority projects, and contribute to the successful launch and lifecycle management of products. Ideal for someone looking to grow their career in a fast-paced, mission-driven organization. Duties and Responsibilities: * Direct activities of staff and manage projects with other cross-functional teams at site * Oversee weekly review meeting with manufacturing site. Provide content for monthly Executive S&OP * Provide PO's and forecasts to contract manufacturers ensuring adequate supply * Ensure material availability to meet Finished Goods Supply plan * Track Demand Vs Commit Vs Supply on ongoing basis * Work with cross-functional team to improve the gap between demand vs commit vs supply * Material planning using various electronic platforms, including SAP, MRP, APO * Coordinate with Site CFT for release of materials as well as Finished products * Track nonmoving, slow-moving inventory; coordinate with corporate team for disposition approvals * Work with DEA team for quota applications of all list chemicals and controlled substances * Work in Trackwise for generating/approving QMS records as required * Issue process orders for manufacturing, in-house packing, and CMO packing * Partner with marketing and finance teams on activities like sales forecast budgets * Approve and/or create order quantities or purchase order push outs; reflow production schedules based on priority * Work effectively with site CFT and drive business priorities * Timely escalation to management on critical supply aspects * Support the monthly Sales and Operations Planning * Manage projects, including new product launches and life cycle changes, across functions and within supply chain to ensure timelines are realized * Other duties as assigned by management * KPI's include: improve sufficiency, reduce backorder, improve demand vs supply, reduce failure to supply, reduce SLOB (API/RM) Qualifications: * Bachelor's degree in Business Management, Supply Chain Management, or Operations Management; Master's preferred * 8+ years' experience in a supply chain role, preferably in the pharmaceutical industry or 6 + years with Masters. * 2+ years leading a team * Familiarity with production planning, supply chain experience, and an understanding of generic pharmaceutical trade sales models preferred * Proficient in Excel and other analysis/reporting tools; working knowledge of SAP * Excellent analytical, mathematical, and verbal/written communication skills * Strong understanding of manufacturing processes Direct Reports: * 2 Supply Planners The presently-anticipated base compensation pay range for this position is $84,500 to $105,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. Notice to Agency and Search Firm Representatives: Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
    $84.5k-105.5k yearly 60d+ ago
  • Process Engineer

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    This position will provide engineering designs and recommendations for assigned processes and new technologies to develop the most cost effective solutions for manufacturing. 1. Prepare, review, approve and distribute the instructions for the production of intermediates or APIs, according to written procedures. 2. Produce APIs and intermediates according to preapproved instructions; 3. Review all production batch records and ensure that these are completed and signed. 4. Report and evaluate all production deviations and ensure that all critical deviations are investigated (with the conclusions recorded). 5. Ensure that production facilities are clean and disinfected; 6. Ensure that all necessary calibrations are performed (with records kept) 7. Maintain the premises and equipment (with records kept). 8. Ensure that validation protocols and reports are reviewed and approved; 9. Evaluate proposed changes in product, process or equipment. 10. Responsible for ensuring that new and modified facilities and equipment are qualified. 11. Review and analyze manufacturing needs, formulate solutions and implement changes to optimize manufacturing processes. 12. Manage assigned projects in order to complete each project on time, under budget and within the design parameters. 13. Provide training for API processes. 14. Other duties as assigned. **Education, Experience & Competencies** 1. BS in Chemical Engineering. 2. 5 years experience with FDA/GMP. Experience with DEA guidelines and regulations a plus. 3. Excellent organization skills. 4. Ability to present ideas effectively to all levels of management. The presently-anticipated base compensation pay range for this position is $101,000 to $112,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $101k-112.5k yearly 31d ago
  • Director / Lead External Manufacturing

    Dr. Reddy's Laboratories 4.6company rating

    Princeton, NJ job

    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 ******************************** *
    $98k-142k yearly est. Auto-Apply 3d ago
  • MSTG Scientist II

    Sun Pharmaceuticals, Inc. 4.6company rating

    Princeton, NJ job

    Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. **Job Summary:** Scientist II, MSTG, performs process development studies, Exhibit batch and process qualification activities. This position also prepares technical documentation to support development and validation program at Sun Pharma. This position provides technical support to Manufacturing and Quality department. **Area Of Responsibility:** + Design and execution of DOEs, process optimization studies, and process qualification batches, Process data compilation and data analysis using statistical tools. + Develop documentation package, involving from conceptual study to various phases of product development like process study, characterization, process qualification and cleaning validation. + Comprehensive understanding of manufacturing technology and equipment used in solid oral manufacturing. + Responsibility for preparation of Master batch records, Exhibit Batch protocols, pre-validation and process validation documentation and reports. + Provide troubleshooting support to manufacturing operations. Complete the assigned projects with minimal supervision. + Champion compliance investigations, commitments (CAPA), and change controls. + Participate on cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships. **Work Conditions:** Corporate Office Environment located in a Manufacturing/Production and Warehouse Facility. Environmental related to manufacturing/production environments: + Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing. + Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction. + Odors: Unpleasant smells. + Gases: Examples include carbon monoxide and ozone. + Dust: Airborne particles of any kind, such as textile dust, wood, and silica. **Physical Requirements:** + Moderate physical effort equal to frequent lifting or moving of lightweight materials up to 10lbs. + Ability to navigate office and plant floor working environments, stands, ambulates, and reaches. + Ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes. **Travel Estimate:** Up to 10 % **Education and Job Qualification:** + Minimum B.S. in relevant science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines. M.S. preferred. + Proficient in MS Office (Word, Excel, Projects, PowerPoint). + Organizational and recordkeeping skills. + Strong analytical thinking, problem solving skills and decision making skills. + Strong communication (verbal and written) skills. + A self-starter with a hands-on approach and a can-do attitude. + The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR). **Experience:** + Minimum six (6) years of experience in solid oral dosage development is preferred . _The presently-anticipated base compensation pay range for this position is $89,000 to $99,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the_ _Long Term Incentive Plan_ _.Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._ _The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._ _The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._ _We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._ **_Notice to Agency and Search Firm Representatives:_** _Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
    $89k-99k yearly 60d+ ago
  • Chief Accountant

    Dr. Reddy's Laboratories 4.6company rating

    Bogota, NJ job

    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.
    $64k-91k yearly est. Auto-Apply 1d ago
  • Senior Manager, Sales Training of Integrated Delivery Network, Reimbursement & Oncology

    Sun Pharmaceutical Industries 4.6company rating

    Princeton, NJ job

    We are seeking a results-driven Senior Manager, Sales Training of Integrated Delivery Network, Reimbursement & Oncology to lead our learning and development initiatives specifically for HSD - Hospital Systems Director, FRM - Field Reimbursement Managers, Hospital Representatives, and Cutaneous Oncology Levulan representatives. The ideal candidate will have extensive experience in sales training and a strong focus on Hospitals, Hospital Systems, Specialty Dermatology, and Oncology training. This is to ensure that our sales teams are equipped with the necessary skills and knowledge to effectively engage with healthcare providers and navigate complex healthcare environments. This position requires a strategic thinker with a deep understanding of the pharmaceutical landscape, exceptional training development skills, and a passion for fostering ongoing professional growth. They will also be expected to have experience with Account Navigation, Market Access and Preferably Buy and Bill Experience. Key Responsibilities 1. Training Program Development: * Design, develop, and deliver comprehensive 5 phase training programs for HSD and Hospital Representatives, Levulan Product Knowledge and Specialty Dermatology/Oncology disease state focusing on product knowledge, selling skills, and reimbursement processes. 2. Needs Assessment and Curriculum Design with a keen knowledge of the 5 D's and project management. * Conduct training needs assessments to identify specific competencies and knowledge gaps within the sales team, especially pertaining to HSDs and hospital ecosystems. * Collaborate with cross-functional teams to create tailored learning solutions that align with organizational goals and address the unique challenges faced by HSD and Hospital Representatives. 3. Training Implementation: * Facilitate engaging training sessions using various formats, including in-person workshops, virtual training, e-learning modules, and role-playing scenarios. * Ensure all training materials are up to date, scientifically accurate, and compliant with industry regulations. 4. Performance Evaluation: * Establish metrics to evaluate training effectiveness and impact on sales performance, using both qualitative and quantitative data. * Conduct regular assessments and provide feedback to sales representatives and FRMs, fostering a culture of continuous improvement. 5. Collaboration and Leadership: * Work closely with the sales leadership team to ensure alignment between training programs and sales objectives. * Collaborate with marketing and medical affairs teams to integrate important clinical and market insights into training initiatives. 6. Coaching and Mentorship: * Mentor and support the development of field sales members, promoting a collaborative learning environment. * Provide ongoing coaching and support to sales representatives to help reinforce the concepts learned in training and enhance their overall performance. 7. Market Insights and Regulatory Awareness: * Stay informed about industry trends, competitive landscape, and regulatory changes that may impact HSD, Nurse Educators and hospital sales strategies. * Integrate this knowledge into training materials to ensure sales teams are equipped to navigate challenges effectively. Qualifications Education: * Bachelor's degree in Business, Life Sciences, or a related field; advanced degree (MBA, PharmD) preferred. Experience: * 7+ years of experience in sales training, with a strong focus on HSD and hospital environments. * Proven experience in developing and implementing HSD, Hospital and Oncology Training Programs is an essential function of this position. Skills: * Strong knowledge of the pharmaceutical, biotech, or healthcare industry, especially regarding hospital systems and HSDs. * Exceptional instructional design skills, with a proficiency in adult learning principles. * Excellent presentation, communication, and interpersonal skills, with the ability to engage diverse audiences. * Strong analytical skills for assessing training effectiveness and sales performance metrics. Software Proficiency: * Proficient in training technologies and Learning Management Systems (LMS), as well as Microsoft Office Suite, Adobe, QSTREAM, Simple show, Vault, Salesforce * This position will require 25% travel to support training programs and engage with sales teams in the field. The presently-anticipated base compensation pay range for this position is $147,000 to $180,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors. Nearest Major Market: New Jersey
    $147k-180k yearly 60d+ ago

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Zydus Pharmaceuticals may also be known as or be related to Zydus Pharmaceuticals, Zydus Pharmaceuticals USA, Inc. and Zydus Pharmaceuticals Usa, Inc.