9 jobs found in Portland, ME

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Purpose: The Account Manager Specialist, Operations Contract Manufacturing (OCM) will be responsible for supporting the biologics contract manufacturing business. The position will be accountable for interactions with customers and general customer support, project management as required, invoicing and tracking of purchase orders. This role will need to understand and manage contracts and contract deliverables for third party programs as well as have a basic understanding of biologics manufacturing. The position will be required to interact with internal stake holders from Manufacturing, Product Development Science and Technology, Quality Organizations, Logistics and Finance departments to ensure the success of the contract programs.  This may entail driving resolutions should issues arise on the programs as well as the coordination of timely communications. Assist with contract extensions and the creation of new scopes of work as required. Responsibilities: Create client...

We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a cross functional team of MES Specialists by providing a QA perspective with regards to manufacturing business processes, documentation requirements, and overall design of records. We are looking for someone who can continuously provide QA input and feedback in accordance with regulations, policies and procedures. In this role, a typical day might include the following: Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact Identifying difficulties and suggesting alternatives that are aligned with QA Reviewing MES change controls and test plans Working with Technical Trainers to develop QA training plans for MES users Collaborating in the creation, review, and approval of validation documents Reviewing and approving MES recipes, master...

The Senior IOPS IT Project Manager will be responsible for delivering complex and strategic IT projects across Applications and Infrastructure for IOPS. Essential Duties and Responsibilities include, but are not limited to, the following: Provide project management and/or business analysis support for the development and implementation of assigned IOPS IT Systems; previous experience using Microsoft Project is required. Work with business owners and key stakeholders to develop project scope, goals, deliverables, required resources, budgets, and timing. Manage and own project delivery within budget, scope, quality and time requirements. Ensures project documents are complete, current, and stored appropriately e.g. Project Charter, Project Plan and Resource Plan etc. Manage day-to-day client interaction and expectations for one or more small to medium scale projects. Create and executes project work plans and revises as appropriate to meet changing needs and requirements....

We are currently looking to fill a Principal GMP Data Governance Specialist position. This role plays a pivotal part in ensuring that Regeneron’s Data Governance systems and practices meet the highest standards of regulatory & industry compliance. The post-holder is responsible for providing specialized knowledge and expertise in the design of Data Governance (DG) frameworks, policies & procedures that are aligned with regulatory requirements and industry standards.     In this role, a typical day might include the following:   Assess current and evolving regulatory guidance & industrial intelligence in relation to IOPS business practices.   Subject Matter Expert (SME) for authoring and developing the standards, policies and procedures in line with regulatory requirements and industry best practices . Technical writing, research, and related editing activities, ensuring accuracy and consistency of documentation and that the...

We are hiring a QA Specialist for our Technical Transfer Start Up Team (TTST). As a QA Specialist you will provide QA oversight in the TTST to ensure manufacturing documentation a nd implementation aligns with Process Transmittals and meet the requirements of Regeneron’s quality system. In this role, typical day may include: Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. Train and/or mentor junior employees, including providing insights and education on processes and procedures. Provides consultation or advice in alignment with QA policies. Review, edit, or approve Regeneron controlled documents. Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials. Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement. Responsible...

We are currently looking to fill a Quality Assurance Specialist position. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. In this role, a typical day might include the following: Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution  Participate as a QA representative on Technology Transfer Startup Teams where responsibilities include providing guidance on QA procedures and polices as well as review of documents for both internal and external transfers Providing consultation or advice in alignment with QA policies Reviewing completed records and batch sheets and working with other departments and communicate internally (Tarrytown, Raheen) and externally...

We are currently looking to fill a Sr QA Project Specialist role supporting our Change Control Business Process Management team. This position supports the achievement of Quality Assurance (QA) objectives by planning, coordinating and leading project activities. This position manages cross-functional projects as both a facilitator and organizer, using knowledge within the pharmaceutical industry and project management techniques. In this role, a typical day might include the following: Lead cross-functional projects and develop project timelines.   Identify and lead project priorities and cross-project dependencies.   Collaborat e with functional leads/subject matter experts in driving execution and removing constraints that prevent advancement of efforts/projects.   Proactively engag e in activities to meet schedules and resolve issues .   Identify skills needed for project management and deploy and...