QvalFocus Inc.

#wearehiring We (#QvalFocus) are looking for a Calibration & Maintenance Specialist who can join Immediately for one of our clients in New Jersey. Job Role: Calibration & Maintenance Specialist Location: Parsippany, NJ Duration: 6+ Months We are looking for a Calibration & Maintenance Specialist to help our Pharmaceutical Client (Oral Solid Dosage Manufacturer) in the cGMP Manufacturing Environment. The Calibration & Maintenance Specialist is responsible for driving the Calibration & Maintenance program in the cGMP areas for API manufacturing. Job Responsibilities: ➤ Perform regular maintenance and calibration of key manufacturing equipment, including tablet presses, fluid bed dryers, and other Manufacturing Equipment, Utility, and Facility systems ensuring compliance with cGMP standards and regulatory requirements. ➤ Diagnose and repair mechanical, electrical, and control system issues on production equipment like chromatography skid systems, coating machines and other equipment minimizing production downtime. ➤ Maintain comprehensive and accurate records of maintenance and calibration activities, including schedules, procedures, and outcomes, in accordance with company policies and regulatory standards. ➤ Work closely with production and quality assurance teams to coordinate maintenance activities, ensuring minimal disruption to manufacturing processes. ➤ Develop and implement preventive maintenance programs for equipment such as granulators (e.g., GEA) and encapsulation machines (e.g., Bosch), aiming to extend equipment lifespan and enhance reliability. ➤ Conduct regular inspections and tests on equipment to verify proper operation and calibration, ensuring accuracy, consistency, and adherence to quality standards. ➤ Oversee the management of spare parts inventory, coordinating with suppliers to ensure the availability of necessary components for timely maintenance and repairs. ➤ Participate in the installation and qualification of new equipment, providing technical support and ensuring all validation protocols and compliance requirements are met. #QvalFocusJobs #hiring #CalibrationMaintenanceSpecialist

#wearehiring We (#QvalFocus) are looking for an Investigations Specialist who can join Immediately for one of our clients in New Jersey. Job Role: Investigations Specialist 📍Location: Parsippany, NJ ⏰Duration: 6+ Months We are looking for an Investigator to help our Pharmaceutical Client (Oral Solid Dosage Manufacturer) in the Manufacturing Environment. The Deviation Investigator is responsible for investigating deviations to the manufacturing process and other operational problems cGMP areas for API manufacturing. Job Responsibilities: ➽ Investigate manufacturing process failures and non-conformances independently to prevent reoccurrences. ➽ Prepare and present investigation reports with recommendations for medium/high severity non-conformances. ➽ Analyze investigation data, summarize findings, and identify trends. ➽ Collaborate with cross-functional teams (manufacturing, QC, Facilities, MSAT, process engineering) to resolve deviations and compliance discrepancies. ➽ Lead cross-functional teams to identify root causes, assess technical impacts, and recommend batch dispositions. ➽ Ensure timely completion of deviation investigations and consistent reporting for regulatory inspections. ➽ Monitor production processes to collect data supporting investigations and track efficiency improvements. ➽ Initiate and oversee corrective and preventive actions (CAPAs) to address deviations and prevent recurrence. ➽ Communicate investigation status, findings, and recommendations effectively with peers and stakeholders. ➽ Provide oversight for technically challenging investigations and manage multiple investigations simultaneously. If you or anyone you know is interested, please message me! ✉ (or) Kindly send your resume to charmi@qvalfocus.com. #QvalFocus #QvalFocusJobs #hiring #InvestigationSpecialist #pharma #pharmaceutical #PharmaceuticalJobs

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*CAR-T (Chimeric Antigen Receptor T-cell) Therapy* CAR-T Therapy, is a novel treatment that modifies a patient's T-cells (T-cells are a type of white blood cell called lymphocytes) to specifically target and destroy certain blood cancers. Researchers are working to make these therapies more effective and safer by using advanced genetic engineering techniques, like adding dual-targeting receptors and safety switches. *Reducing Relapse & Toxic Reactions has been the current focus* Follow us QvalFocus Inc. for latest trends and jobs in the Industry. #CART #Beginnersread #NovelTherapies #Biologics #FutureOfMedicine #QvalFocus https://lnkd.in/eR83bNEA.

FDA approves first two interchangeable biosimilars to Regeneron's blockbuster Eylea Eylea will eventually have competition in the US, as the FDA approved two interchangeable biosimilars. Monday’s approvals for Biocon Biologics’ Yesafili and Samsung Bioepis and Biogen’s Opuviz are based on the companies’ ability to show that their aflibercept competitors have no clinically meaningful differences from brand-name Eylea. Yesafili won approval in the UK last November and in Europe last September. “This evidence included comparisons of each product to Eylea on an analytical level using an extensive and robust battery of physicochemical tests and biological assays, and in a comparative clinical study in patients,” FDA said in announcing the approvals. Sandoz also has another Eylea biosimilar in the works. While most interchangeable biosimilars have to run switching studies to win approval, FDA confirmed to Endpoints that neither interchangeable for Eylea had to run such studies. The agency said “the risk of a clinically impactful immunogenic response when alternating or switching between Yesafili and Eylea or Opuviz and Eylea is low. Thus, a switching study that compares immunogenic responses to assess whether the risk of alternating or switching between Yesafili and Eylea or Opuviz and Eylea were unnecessary for either product.” But because of remaining patents on Eylea, analysts don’t expect either of the two new biosimilars to launch until 2027. In August, Regeneron also launched a high-dose version of Eylea that it hopes will become the standard of care in several retinal diseases. In its first-quarter filing, Regeneron recorded $200 million in US sales of the high-dose version, and about $2.3 billion in worldwide sales of Eylea and Eylea HD. Competition from interchangeable biosimilars is increasing for some of the biggest drugs in the world, including AbbVie’s Humira. Regeneron reported more than $12 billion in Eylea sales in 2022 and 2023. Eylea may also be up for Medicare negotiations in the next few years — in 2022, Medicare Part B spent more money on Eylea than any other drug except Merck’s Keytruda. https://lnkd.in/eSRuCBTs

Regeneron on Wednesday revealed that its investigational gene therapy DB-OTO restored hearing in two young children, according to an oral presentation at the American Society of Gene & Cell Therapy annual meeting. #ASGCT24 #ASGCT #biospace https://hubs.li/Q02wxsFr0

#wearehiring #QvalFocusHiring We (#QvalFocus) are looking for Full Stack Java Developers who can join Immediately for one of our clients. Role: Sr Software Engineer Location: Richmond, Virginia Employment Type: W2 Mode of Work: Onsite / Hybrid Resumes To: krish@qvalfocus.com What we are looking for: 5 years of Java development experience with complex, large-scale applications using the following technologies is required: Java/J2EE, HTML/CSS, JavaScript, SQL. 3 years’ experience with the following technologies: SOAP & REST Web Services, JSPs, Struts, Spring, JDBC, JPA/Hibernate, and JMS. Experience with relational and object-oriented modeling is required. Experience with IBM WebSphere Application Server, IBM WebSphere Liberty, and Oracle RDBMS is strongly preferred. Experience with Spring Batch and Spring Boot is strongly preferred. Experience with technical requirements specification and design documentation is required. Experience with problem troubleshooting and providing support for complex multitiered applications is required. Experience with UNIXOS, UNIX Shell Scripting, PL/SQL, and UML is strongly preferred. Experience with large-scale data migration is preferred. #QvalFocus #Java #J2EE #Spring #MVC #JMS #html #javascript #css #SQL #SOAP #REST #WebServices

FDA Approval Fuels Boehringer’s Biosimilar Challenge to AbbVie’s Humira The FDA on Wednesday approved a high-concentration and citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), its interchangeable biosimilar to AbbVie’s blockbuster antirheumatic treatment Humira (adalimumab). The high-concentration version of Cyltezo, which carries a 100-mg/mL dose of the biosimilar, comes in a pre-filled syringe or autoinjector and is sold at a 5% discount to the branded reference product. An unbranded version of Cyltezo is also available at an 81% discount to Humira. A low-concentration, 50-mg/mL version of the biosimilar has been on the market since July 2023, according to Boehringer Ingelheim. Stephen Pagnotta, biosimilar commercial lead at Boehringer Ingelheim, in a statement said that this latest Cyltezo approval will further expand “treatment access for patients living with certain chronic inflammatory diseases.” Approved in October 2017, Cyltezo is an interchangeable biosimilar to Humira and is indicated for all the same conditions, including moderate-to-severe rheumatoid arthritis, Crohn’s disease and ulcerative https://lnkd.in/ersnayWD