Author and provide input to critical Validation systems and conduct validation assessments of equipment, Facilities, and process systems. Compile and analyze data, prepare protocols, reports, and make recommendations for changes/or improvements.

Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications.

The PDTS Technician I perform activities supporting the function in executing daily operations in the Pilot Plant, as well as Research and Development.

The Manager, QMS – Quality Agreements, US, will ensure Alvogen’s quality agreements for drug products and medical device / combination products, through both development and post approval / commercial phases, are tracked and managed in a sustainably compliant manner, for the U.S Business Region. The role is responsible for supporting the establishment of associated procedures covering the management and effective use of quality agreements, driving implementation of such procedures and actively managing related procedural changes. The role is responsible for interacting closely with and supporting associated Quality Unit stakeholders at NPI and at Morristown NJ (TPQ-US), as well as other internal stakeholder functional groups and external business partners, to track and manage all required quality agreements to support the U.S. Business Region.

The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.  Submissions will include ANDAs, amendments, supplements, Annual Reports and advertising and promotion campaigns.

The Senior Network Engineer’s main role is to maintain, secure, optimize, expand and support Alvogen’s network infrastructure. The hands-on Senior Network Engineer to analyze, implement, design, operationalize and manage local LAN networks, company WAN and cloud networks on a global level spanning multiple time zones.

The Manager Combination Product Quality will ensure Alvogen’s medical device and combination product development, operations, and post-market processes and procedures are sustainability compliant at the Norwich (NPI) manufacturing site. The role is responsible for supporting the establishment of procedures, driving implementation, and actively managing related change and communications. The incumbent will serve as the designated Management Representative for the Norwich facility. The role will also provide technical quality leadership and support for NPI’s medical device and combination products. The incumbent will collaborate with internal and external partners for product development and lifecycle management efforts to ensure product design history and risk management files are in accordance with regulatory requirements and international standards (e.g., ISO, AAMI, ANSI). S/he will be responsible to lead risk management activities, as well as to provide support through post-market surveillance, design changes, etc.

This position will be supporting the US Finance operations as it relates to actual and forecast reporting. The goal of this role is to help drive continuous improvement into faster and deeper analysis around the monthly results as well as business decisions for future strategic endeavors through the creation of better reporting tools and platforms.

The Method Development and Analytical Services (MDAS) Research Associate II is an experienced resource in performing sample testing and validating the methods necessary to support development and commercialization of pharmaceutical products.

The Manufacturing & Packaging Technician is responsible for the semi-finished or finished product by using required skills to operate, adjust, clean and set-up equipment in order to maintain quality, safety and regulatory standards for the production and distribution of pharmaceutical products.

The Method Development and Analytical Services (MDAS) Research Assistant provides laboratory support and performs analytical testing supporting development of new pharmaceutical products.

The role of Associate Director, Procurement is to ensure efficient acquisition of contract development and manufacturing services from third party CDMO suppliers that enables the commercialization and distribution of our products.

The Director Combination Product Quality will ensure Alvogen’s medical device and combination product development and post-market processes and procedures are sustainability compliant. The role is responsible for setting strategies, driving implementation, and actively managing related change and communications.

The Senior Director, External R&D is responsible to provide strategic R&D direction with a special focus on Third Party generic R&D projects, 505b(2) projects, tech transfer and R&D Due Diligence.  This is a key role with a wide responsibility to assist in portfolio selection, due diligence activities, oversee external development, and serve on project teams. Focus of this role is on both Solid oral  and non-Solid dosage forms such as injectables, inhalation products, transdermal products, topical products etc.  

The Quality Manager is a member of the US Quality department. In this position, the QA Manager will have oversight and hands on management of: release testing and stability programs for complex sterile products – US and ROW. Tracking all testing, results for release, investigating shipping temperature excursions, manage and approve protocols for new stability programs, monitor ongoing stability programs, laboratory OOS/deviations, and managing change controls ensuring adherence to regulatory applications and Alvogen’s Quality Management System. Batch record review and batch release of product

Independently authors, compiles, reviews and submits high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files.