Ahmedabad, Gujarat, India · On-site
Key Responsibilities • Nonclinical safety and toxicology study design & execution - 1. Design, plan, and conduct in vivo and/or in vitro safety pharmacology and toxicology studies in alignment with GLP principles. 2. Sel…
Skills: Nonclinical Safety, Toxicology Study Design, GLP Compliance, Regulatory Submissions, Risk Assessment
Hyderabad, Telangana, India · On-site
Responsible as Department training coordinator (DTC). •Responsible for training management activities. •Responsible to upload training copy of SOP in training software •Responsible to provide training log of employees in…
Skills: Quality Assurance, People Management, Compliance Audit, Talent Acquisition, Learning And Development
Hyderabad, Telangana, India · On-site
Description: Responsible for implementation of approved procedures and responsible for system and facility compliance audits. •To conduct or be part of team conducting risk assessment of various activities, equipment, sy…
Skills: Quality Assurance, Risk Assessment, CAPA, Root Cause Analysis, cGMP
Sarkhej, Gujarat, India · On-site
Key Responsibilities Perform routine Environmental Monitoring (EM) activities in classified cleanrooms (Grade A, B, C, D areas). Conduct viable and non-viable monitoring including- Active air sampling, Surface monitoring…
Skills: Environmental Monitoring, Microbiological Testing, Sterility Testing, Aseptic Handling, GMP Compliance
Sarkhej, Gujarat, India · On-site
Key Responsibilities Lead and manage the Environmental Monitoring (EM) program for sterile injectable and peptide manufacturing areas (Grade A, B, C, D cleanrooms) including Isolator based lines. Individual should have t…
Skills: Environmental Monitoring, Microbiology, Sterile Injectable Manufacturing, Cleanroom Management, Root Cause Analysis
Sarkhej, Gujarat, India · On-site
Key Responsibilities Lead and manage the QC Chemical (Analytical) department for sterile injectable and peptide-based formulations. Oversee analysis of Raw Materials, In-Process Samples, Finished Products, Stability Samp…
Skills: QC Laboratory Management, Analytical Method Validation, Peptide Characterization, HPLC, UPLC
Sarkhej, Gujarat, India · On-site
Key Responsibilities Lead and manage the QC Chemical (Analytical) department for sterile injectable and peptide-based formulations. Oversee analysis of Raw Materials, In-Process Samples, Finished Products, Stability Samp…
Skills: QC Analytical Management, Peptide Characterization, Sterile Injectables, Analytical Method Validation, Regulatory Compliance
Brookhaven, New York, United States · On-site
Description: This role will be responsible for maintaining cleanliness and sanitation in our pharmaceutical manufacturing and office facilities. The Janitor will be responsible for ensuring a sterile environment in compl…
Skills: Sanitation, Waste Disposal, Chemical Handling, GMP Compliance, Facility Maintenance
Bridgewater, New Jersey, United States · Hybrid
$90k–$105k/yr
Description: Amneal Pharmaceuticals LLC is seeking a Senior Payroll Analyst to lead and manage daily payroll operations, ensuring accuracy, compliance, and timely processing. This role is crucial for the smooth functioni…
Skills: Payroll Processing, ADP Workforce Now, UKG Kronos, Multi-state Payroll, Payroll Auditing
Piscataway, New Jersey, United States · On-site
$22/hr–$29/hr
Description: The Transdermal Operator II (3rd Shift) responsibilities include equipment start-up, participation in ANDA batch production and commercial batch manufacturing. Primary responsibilities include in process che…
Skills: Equipment Set-up, GMP Compliance, Troubleshooting, Data Entry, Mechanical Skills
Brookhaven, New York, United States · On-site
$68k–$85k/yr
Description: The Associate Scientist, Analytical Chemistry is an entry level, and it contributes to tasks associated to pharmaceutical analysis intended for drug product development. The preliminary activities include fo…
Skills: Analytical Chemistry, HPLC, cGMP, Pharmaceutical Analysis, SOP Compliance
Yaphank, New York, United States · On-site
$93k–$123k/yr
Description: The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures…
Skills: Analytical Chemistry, HPLC, Dissolution Testing, cGMP, Method Transfer
Piscataway, New Jersey, United States · On-site
$18/hr–$26/hr
Description: The Transdermal Operator I supports transdermal manufacturing and packaging operations in a cGMP-regulated environment. This role includes operating equipment under supervision, assisting in basic mixing, co…
Skills: cGMP, Equipment Operation, Packaging, In-process Inspection, Documentation Practices
Gurgaon, Haryana, India · On-site
Description The Key Accounts Manager will own end-to-end engagement with designated major hospital accounts and KOLs/KBLs to grow revenue, secure formulary/access, and convert opportunities. This role requires strategic …
Skills: Account Management, Value-Selling, Stakeholder Relationship Management, Sales Forecasting, Pipeline Development
Glasgow, Kentucky, United States · On-site
Description: The Logistics Analyst is responsible for analyzing, optimizing supply chain and logistics operations and other multiple processes as required to improve efficiency, reduce costs, meet regulatory requirements…
Skills: Data Analysis, Forecasting, Process Improvement, Supply Chain Optimization, Inventory Management
Brookhaven, New York, United States · On-site
$27/hr–$36/hr
Description: The Amneal Global Corporate Security and Investigations (GCSI) Special Investigator performs comprehensive and complex investigations related to external/internal thefts, compliance investigations, diversion…
Skills: Complex Investigations, Pharmaceutical Diversion Tracking, CCTV Monitoring, Access Control, Interviewing
Brookhaven, New York, United States · On-site
$105k–$115k/yr
Description: The Sr. Quality Management Systems Specialist provides coordination and reporting that includes data collection/generation, data analysis and data review and interpretation. In addition, prepares summary fin…
Skills: Data Analysis, Quality Management Systems, Change Control, CAPA, Regulatory Compliance
Piscataway, New Jersey, United States · On-site
$65k–$85k/yr
Description: The Associate Process Engineer provides support to the operation Manager/Associate Director Operation/ Engineering in implementing improvements, validation and automation to the plant operations and assist i…
Skills: Process Validation, Equipment Validation, SOP Writing, Root Cause Analysis, CAPA Implementation
Ahmedabad, Gujarat, India · On-site
Key Responsibilities: Secretarial Function: Manage the secretarial compliances. Board & Shareholder Meetings: Organize, conduct, and document meetings of the Board of Directors and shareholders. Companies Act Compliance:…
Skills: Secretarial Compliance, Board Meeting Management, Companies Act 2013, FEMA Compliance, CSR Compliance
Gujarat, India · On-site
Description: The role is responsible for ensuring effective day-to-day technical support to employees across a range of hardware and software systems. Handle QMS Activities. Support Laboratorty shop floor. The role focus…
Skills: Technical Support, Hardware Troubleshooting, Software Troubleshooting, Incident Management, SLA Adherence
Ahmedabad, Gujarat, India • On-site
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Lead and manage non-clinical safety and toxicology studies for early and late-stage drug development programs. Collaborate with cross-functional teams to ensure seamless molecule advancement and contribute to global regulatory strategies and submissions.
Requires a Master's or PhD in Toxicology or a related biomedical science with 8-10 years of preclinical experience, including 5 years as a GLP Study Director. Must have proven expertise in regulatory submissions for USFDA, EMA, and DCGI.
Key Responsibilities
• Nonclinical safety and toxicology study design & execution -
1. Design, plan, and conduct in vivo and/or in vitro safety pharmacology and toxicology
studies in alignment with GLP principles.
2. Select appropriate species, study duration, and endpoints based on pharmacology,
pharmacokinetics and regulatory requirements.
3. Review study raw data, protocols, results and reports.
4. Oversee study execution, ensure data accuracy, and coordinate with CROs or internal cross
functional teams.
• Risk Assessment & Safety Evaluation -
1. Analyse and interpret the safety and toxicology data and integrate findings with pharmacokinetics and pharmacodynamics to assess potential safety risks.
2. Perform toxicological risk assessments including PDE/OEL/ADI derivations, impurity/excipient qualification assessments, extractables & leachables evaluations, and safety margin calculations.
3. Conduct exposure assessments for process materials, impurities, metabolites, degradation products and excipients.
• Regulatory & Documentation -
1. Prepare and review high-quality safety and toxicology study reports, technical summaries, and nonclinical sections of regulatory submission documents (IND, NDA/MAA, ANDA, eCTD Modules 2.4/2.6 & 4, briefing books and IB, etc.).
2. Support regulatory filings to USFDA, EMA, DCGI, and other global agencies.
3. Draft and review regulatory query responses, briefing documents, and expert justifications.
• Toxicology Informatics & Literature Research -
1. Perform comprehensive literature searches using toxicity databases (e.g., PubMed, TOXNET, ECHA, HSDB, etc.,).
2. Utilize modern toxicity prediction & risk assessment software/tools (e.g., DEREK Nexus, CASE Ultra, OECD QSAR Toolbox, etc.).
3. Interpret computational toxicology outputs and integrate them into safety evaluations.
• Compliance & Quality -
1. Ensure full adherence to global regulatory guidelines (ICH, OECD, EMA, and USFDA).
2. Support internal audits, regulatory inspections, and quality compliance activities related to toxicology studies.
• Cross-Functional Collaboration
1. Work closely with Pharmacology, ADME, DMPK, CMC, Clinical and Regulatory Affairs teams.
2. Represent toxicology in project meetings and contribute to risk/benefit evaluations.
The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key roles that the Human Resources team performs:
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
We make healthy possible.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US
We make healthy possible.
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US
