115 jobs found in Springfield, MA

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. 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). Medical Science Liaison, Endocrinology Position Summary The Medical Science Liaison, Endocrinology (MSL) is a field-based medical role focused on building and maintaining scientific partnerships with healthcare professionals (HCPs) and key decision-makers through non-promotional, evidence-based scientific exchange. The MSL will serve as a key liaison for Madrigal’s...

Company Description   Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X ....

If you’re a student pursuing a Undergraduate degree in Bioinformatics, Statistics, Mathematics, Data Science, Information Technology, Biostats, Omics, Imaging, or related majors, you may be a fit for an Internship in many of our departments. Please apply to one Internship of interest that best matches your major. In this role, a typical summer might include the following: Achieving a general understanding of what happens in our global organization Completing hands-on project work that has an impact on the business Engaging with Regeneron leadership Collaborating with a specific hiring manager and other interns Establishing connections with Regeneron’s diverse set of employee resource groups Participating in professional development sessions while enjoying lots of free food and swag Showcasing the knowledge you gained through end of program presentation sessions Getting paid for your hard work! This role might be for you if: You want to make a difference You...

If you’re a student pursuing a Graduate degree in Bioinformatics, Computer Science, Statistics, Mathematics, Data Science, Information Technology, Biostatistics, Omics, Imaging, or related majors, you may be a fit for an Internship in many of our departments. Please apply to one Internship of interest that best matches your major. In this role, a typical summer might include the following: Achieving a general understanding of what happens in our global organization Completing hands-on project work that has an impact on the business Engaging with Regeneron leadership Collaborating with a specific hiring manager and other interns Establishing connections with Regeneron’s diverse set of employee resource groups Participating in professional development sessions while enjoying lots of free food and swag Showcasing the knowledge you gained through end of program presentation sessions Getting paid for your hard work! This role might be for you if: You want to make a...

At AstraZeneca we turn ideas into life-changing medicines and we’re looking for big thinkers who thrive in a highly collaborative and entrepreneurial environment - where we can make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world and are building on a 40-year heritage in respiratory disease. Our team is dedicated to transforming the treatment of asthma and respiratory diseases. Are you ready to make a difference? Respiratory disease is one of AstraZeneca's three strategic priorities, and we have a growing portfolio of medicines that reach millions of patients each year.  Our aim is to transform asthma and COPD treatment through inhaled combinations, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are leveraging novel combinations, biologics, and devices to treat patients now and our research is focused on four key biological pathways:...

Pharmaceutical Sales Specialist - R& I Primary Care- Worcester, MA At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Pharmaceutical Sales Specialist for the Primary Care Team, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives! Accountabilities...

At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Senior Pharmaceutical Sales Specialist for the Specialty Care Team, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Accountabilities - Develop and demonstrate strong knowledge of clinical disease states and treatment...

JOB WEIGHTING:   Job Weighting% Main Responsibilities 40% •Responsible for all medical affairs activities in the therapeutic area. 40% •Responsible for scientific exchange with external experts in the therapeutic area 20% •Responsible for recruiting, coaching, managing MSL for team development and medical strategy execution   REQUIREMENTS:                   Medical Degree, MD or PhD is a plus. Strong background in clinical practice Suitably qualified individuals from a scientific background and relevant experience will also be considered in exceptional circumstances Previous medical affairs pharmaceutical or biopharmaceutical industry experience is essential A demonstrated understanding of drug development and commercialization processes, have sound and current knowledge of the regulatory environment, significant experience in overseeing or conducting clinical trials, a solid understanding of trial design and methodology and an understanding of the need...

The MSL/Senior MSL is a field based scientific expert that strategically supports the research and business objectives of a designated therapeutic area across the product life cycle for a specific geography/territory    The MSL/Senior MSL is the primary communicator of AbbVie science within a specific geography with healthcare professionals.   The MSL/Senior MSL develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to AbbVie initiatives in assigned therapeutic areas.      The MSL/Senior MSL is viewed as a peer scientific expert in a designated therapeutic area/product.    Combined with strong strategic vision, market therapeutic area awareness, as well as clinical expertise, the MSL/Senior MSL serve as a conduit of information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized...

Reporting to the MSL Manager, your main responsibilities will be as follows: Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice. Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.  Ensure a strong medical and scientific presence for AbbVie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie. Assist in the initiation; oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility (e.g. post marketing clinical activities such as registry/ database...

Regeneron is currently seeking an Associate Director to join our Downstream Sciences and Investigations (DSIG) team. The Associate Director- Process Sciences leads a lab based team responsible for the assessment of changes to raw materials and their impact to Manufacturing operations and product quality. The role also maintains awareness of industry and regulatory trends to manufacturing technologies and material sciences to assess and support implementation within IOPS to remain in the forefront of industry.   As an Associate Director- Process Sciences a typical day may include: Leads cross-functional teams in generating and analyzing data to assess raw material attributes for impact to new and existing manufacturing processes which include change notifications, secondary sourcing, raw material investigations, and impurity/byproduct/extractable risk assessments. Perform risk assessments for changes to raw materials to determine potential impact to the processes. Leads...

Regeneron is currently looking for a Quality Control (QC) Analyst for our QC Raw Material Utility laboratory with a 1st shift, Monday-Friday, 6am-2:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The QC raw material utility laboratory performs testing of the raw materials used in the manufacturing process. Various raw materials are tested in the laboratory using manual or instrumentation testing procedures.     As a QC Analyst, a typical day might include the following: • Train other employees on laboratory activities • Utility (water/gas) testing • Data review • Perform laboratory investigations • Write / revise laboratory related documentation (e.g. SOPs, SPECs) • Maintain laboratory supplies • Ensure continuous laboratory compliance to cGMP requirements (e.g. Laboratory cleanliness, equipment within calibration, proper...

Regeneron is currently looking for an Analytical Specialist position with a 1st shift, Monday-Friday, 8am-4:30pm schedule. This position is part of the Analytical Sciences Chemistry Method Development Team. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product through Process Validation. This position will be responsible for development and troubleshooting of chromatography and spectrometric-based assays utilized in Quality Control testing. In this fast pace environment with a strong pipeline, Analytical Specialists have the opportunity to develop scientifically but also gain insight into other areas of the business. As an Analytical Specialist, a typical day might include the following: Work cross-functionally to bring new assays into the group from our research groups. Design and execute assay development experiments to...

We are looking to add an Executive Director Quality Control to our team in Rensselaer, NY! This role leads activities in Quality Control, including but not limited to: release and in-process testing, stability testing, lab investigations, manufacturing failure investigations, environmental monitoring and microbiological testing. Providing comprehensive testing support to clinical and commercial manufacturing, regulatory inspections, filing and facility operations. Leading operational and technological collaboration between the QC group and its business partners. In this role, a typical day might include the following: Leading a full scale of QC operation to support production, facility and cGMP compliance. Providing broad experience and guidance for biopharmaceutical quality control and analytical testing. Interpreting scientific data and draw reasonable conclusions. Advising manufacturing, QA, RA, facilities and material management of quality control requirements and...

Regeneron is currently seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing, functional testing for combination drug products and raw material testing. This role will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of the QC method validation of the methods for incoming components including visual inspection, functional testing, compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies. As an Associate Director , a typical day might include the following: Support filling operations for any technical support. QC method validation and transfer processes. Maintain open communications with scientist including internal, partner and contract manufacturing organizations. Provide direction to Managers and scientist that support the method development, validation and...

The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. A typical day might include the following: Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supply Collaborates cross-functionally to support the submission strategies and impacts on supply and regulatory release processes Support the regulatory submission forms to support regulatory release and QP certification. Foster strong communication and working relationships between IOPS and Global Development Keeps management and all stakeholders informed of assessments, overall strategy, and project status Works within the procedures and systems for enhanced tracking of global regulatory submission packages and approval status....

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst with a 3rd shift, Wednesday-Sunday, 10pm-8:30am schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Microbiology Analysts perform microbiological assays, related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation. This position will be primarily responsible for performing routine environmental monitoring for aseptic fill/finish manufacturing areas, utilities sampling and testing, , gowning and aseptic qualifications, and raw materials, in process and finished product testing related to drug manufacturing. As a QC Micro Analyst, a typical day might include the following: Environmental monitoring of controlled environments, personnel and...

Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.    As a QC Micro Specialist, a typical day might include the following:   Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.  Implement verified methods...

The MSL/Senior MSL is a field based scientific expert that strategically supports the research and business objectives of a designated therapeutic area across the product life cycle for a specific geography/territory    The MSL/Senior MSL is the primary communicator of AbbVie science within a specific geography with healthcare professionals.   The MSL/Senior MSL develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to AbbVie initiatives in assigned therapeutic areas.      The MSL/Senior MSL is viewed as a peer scientific expert in a designated therapeutic area/product.    Combined with strong strategic vision, market therapeutic area awareness, as well as clinical expertise, the MSL/Senior MSL serve as a conduit of information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized...