Full-Time
Maintenance Supervisor
First shift
American Regent
501-1,000 employees
Produces sterile injectable medications for healthcare
Compensation Overview
$91k - $105k/yr
Shirley, NY, USA
In Person
Bachelor's
 General Maintenance & Repair (1) |
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- A high school degree is required; a Bachelor of Arts or Bachelor of Science degree is preferred.
- At least one year of experience in a leadership role is required.
- Five to seven years of relevant mechanic experience and previous pharmaceutical industry experience are required.
- Previous supervisory experience is required.
- Ability to follow instructions and document activities according to standard operating procedures.
- Ability to communicate effectively.
- Basic Microsoft Office and Windows skills are required.
- Knowledge of safety programs such as lockout/tagout and line breaking is required.
- Advanced skills in electrical work, welding, machinery troubleshooting, and mechanical equipment are required.
- Ability to work multiple shifts and off-hours during shutdowns, including some overtime, weekends, and a regular off-shift assignment as needed.
- Ability to lead a project and provide direction is required.
- Ability to perform the physical duties of the role, including standing, walking, stooping, bending, kneeling, climbing steps, using hands and arms, and lifting up to 50 pounds.
- Ability to wear cleanroom and protective equipment, including goggles, face shields, respirators, and protective gloves.
- Initiate, implement, and manage a process equipment maintenance program based on industry best practices, emphasizing planning, scheduling, and preventive and predictive maintenance.
- Coordinate and direct projects and process mechanics by creating detailed plans and directing the integration of technical activities.
- Ensure equipment is ready for daily and weekly startup, focusing on problem areas.
- Coordinate maintenance mechanics and adjust daily schedules to support operations.
- Ensure preventive maintenance tasks are completed promptly and coordinated with manufacturing.
- Act as a liaison with management to ensure department goals are met.
- Coordinate shutdown activities and schedule preventive maintenance and repair work.
- Supervise process maintenance mechanics, including prioritizing and evaluating work, recommending and approving personnel actions, assessing competencies, and providing training.
- Develop, implement, and measure plans to address competency gaps.
- Hire process mechanics.
- Prepare reports, analyze data, and provide recommendations to improve equipment operations and resolve maintenance problems.
- Track, analyze, and improve asset utilization, maintenance costs, preventive maintenance compliance, and schedule compliance for manufacturing equipment.
- Manage manufacturing equipment parts inventory while balancing spare-parts availability and internal inventory costs.
- Initiate and execute projects that improve efficiency or reduce operating costs.
- Coordinate manufacturing equipment maintenance efforts with the Engineering group and other relevant teams.
- Manage the use of external contractors.
- Participate in developing and reviewing equipment standard operating procedures.
- Ensure applicable standard operating procedures are followed and maintain compliance with current good manufacturing practices.
- Assist supervised personnel with manufacturing difficulties.
- Ensure personnel under supervision receive proper training and participate in cost-estimating activities.
- Meet regularly with mechanics, communicate company information, develop goals and action plans, and review progress and performance.
- Maintain and update operating and training manuals for mechanics.
- Coordinate communications among various shifts.
- Provide leadership in creating and maintaining a safe workplace.
- Participate in deviations, corrective and preventive actions, and change controls, from investigations through execution.
- Perform other duties assigned by management.
American Regent is a pharmaceutical company that develops, manufactures, and supplies sterile injectable medicines for U.S. and Canadian healthcare providers, including brands and generic injectables. Its products are produced in sterile form and used by hospitals, clinics, and other providers to treat patients. The company operates manufacturing sites in New York, Ohio, and Pennsylvania and ships across the United States and Canada, aiming to ensure a steady, broad portfolio of injectable therapies for patients. It differentiates itself through its commitment to reliable supply and through ongoing investments to modernize and expand its U.S. manufacturing capabilities, supporting sustainable growth and the well-being of its employees and customers. Its goal is to maintain a steady supply of high-quality injectable medicines by expanding capacity and improving efficiency to serve the healthcare marketplace.
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
New York
Founded
N/A
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Simplify's Take
What believers are saying
- New Albany construction runs through October 2027, adding manufacturing capacity now.
- Workforce reached 1,191 employees in March 2026, signaling continued hiring.
- Injectafer litigation settled, letting generic ferric carboxymaltose enter July 1, 2026.
What critics are saying
- Two 2026 recalls found glass, paraformaldehyde, and fibers across human and animal injectables.
- Papaverine lot 25202 and Adequan lots 25011, 3369, 24416, 25265P damaged trust.
- Repeated contamination failures invite FDA scrutiny, plant disruption, and an existential quality-system collapse.
What makes American Regent unique
- Daiichi Sankyo backs American Regent with sterile-injectable scale and capital discipline.
- New Albany expansion targets oncology production, strengthening U.S.-made injectables capacity.
- The company spans human and animal health, including Injectafer and Adequan franchises.
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Company News
American Regent, Inc. issues voluntary nationwide recall of one lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL due to the presence of visible particulate matter. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Summary. * Company Announcement Date: - July 24, 2026 * FDA Publish Date: - July 27, 2026 * Product Type: - Drugs * Reason for Announcement: - Products were found to contain particulate matter * Company Name: - American Regent, Inc. * Brand Name: - American Regent, Inc. * Product Description: - Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Company Announcement. July 24, 2026 - Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass and/or paraformaldehyde. Risk Statement: The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Patients with underlying cardiovascular or pulmonary compromise may be at increased risk. To date, American Regent, Inc. has not received any reports of adverse events related to this recall. Papaverine is a prescription medication that relaxes smooth muscles and widens blood vessels, primarily used to treat visceral spasms, poor blood circulation, and erectile dysfunction. Papaverine Hydrochloride Injection, USP, is a clear, colorless pale-yellow solution and is available in a 2 mL single-dose vial containing 30 mg/mL Papaverine Hydrochloride Injection, USP Lot # 25202 was distributed nationwide in the United States beginning September 30, 2025. NDC, lot, expiration date and distribution dates can be found on the table below. Product Description: Papaverine Hydrochloride Injection, USP 60 mg/2 mL Single dose vial NDC: 0517-4002-25 Lot#: 25202 Expiration Date: 11/30/2026 Distribution Dates: 9/30/2025 American Regent, Inc. is notifying its distributors and customers by letter and is arranging for return/replacement etc. of all recalled products. Distributors/retailers/healthcare facilities that have the product which is being recalled should stop using and return to place of purchase or discard the product. Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information. This product is an intravenous injection and is to be used by or under the direction of a physician. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. | Contact Center | Contact Information | Area of Support | | American Regent, Inc. Customer Service | Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday - Thursday, 8:00AM-4:00PM EST, Friday) | For detailed return/replacement/credit information | | American Regent, Inc. Pharmacovigilance | Phone: 800-734-9236 Email: [email protected] | To report adverse events | | American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday - Friday) Email: [email protected] | For product quality complaints | | American Regent, Inc. Medical Information | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday - Friday) Email: [email protected] | For medical questions | Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. * Complete and submit the report Online: www.fda.gov/medwatch/report.htm * Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. American Regent, Inc. is committed to the safety of patients who rely on its products and is taking this precautionary action to protect public health. Company Contact Information. * Consumers: - (800) 645-1706
American Regent recalls Papaverine Injection nationwide. When glass and medicine don't mix. Walking a tightrope in pharmaceutical production is no small feat, but American Regent, Inc. just stepped off the safety line with a recall of their Papaverine Hydrochloride Injection. Investors Hangout, LLC is talking visible glass and paraformaldehyde floating in those vials like unwelcome party guests. That's a gamble nobody wants to take, especially when you're injecting it straight into the bloodstream. The stakes: Health risk in a bottle. Now here's the rub: if this gunk gets injected, it could lead to local irritation, or worse, block blood vessels in critical areas like the heart, lungs, or brain. Best case scenario? You've got some irritation. Worst? You're looking at strokes or death. It's a dangerous line to walk, especially for those already dealing with cardiovascular or pulmonary issues. "Nobody's reported problems yet, but this ain't a bet you want to place." From distribution to recall: the details. The recalled batch, Lot #25202, made its way around the U.S. starting from September 30, 2025. American Regent didn't waste time getting the word out, notifying distributors and healthcare providers via formal letters. But let's break it down - why did this take almost a year to come to light? Crucial steps for stakeholders. * Cease usage and return the product to its purchase point. * Health facilities, retailers, and consumers are urged to discard or return the vials. * Contact healthcare professionals if the drug has been used. Sure, American Regent is taking steps to mitigate the damage, but national recalls are no picnic. Investors Hangout, LLC is talking production line inspections, possibly halts, and a blow to the company's reliability perception. You can practically hear their stock value holding its breath. Pharmaceutical oversight under the spotlight. Sold under the radar until last September, these vials pack 60 mg in a pale-yellow solution meant to ease visceral spasms and boost circulation. With no reports of adverse events yet, healthcare providers would be wise to tread carefully and follow guidance to avoid any hit or miss scenarios. American Regent's commitment to safety. Now, they claim their commitment to patient safety is top-tier. They're working closely with the FDA in an effort to spell out transparency. Here's hoping this isn't a case of too little, too late. Communication lines are open with customer service covering details about returns, replacements, and the full lowdown of the recall. While investors should probably keep watch on American Regent, this recall isn't sending shockwaves across the stock market just yet. The regulatory hiccups, though, raise questions for potential future oversight and quality measures in pharmaceutical manufacturing. And in this landscape, vigilance and swift action are the golden rules. If you're holding any stake in the healthcare sector or pharmaceuticals, keep an eye peeled for broader implications. Recalls like this signal a hiccup in the seemingly smooth operations, but they're crucial for ensuring safety and maintaining trust in medical supply chains.
Allegro's osteoarthritis hydrogel resolves lameness in animal study. Allegro NV * The hydrogel resolved lameness in 72% of horses treated * Horses provide a strong translational model for human osteoarthritis * Clinical investigation authorized by Belgian regulatory authority * Allegro's hydrogel is first-in-class potentially disease-modifying osteoarthritis device candidate Liege, Belgium - 12 March 2026 (08:30 CET) - Allegro NV, a biomedical company developing transformative nanotechnology treatments for degenerative joint disease, has demonstrated that its proprietary injectable hydrogel significantly improved joint mobility in horses with osteoarthritis. In a proof-of-concept study in 40 mature thoroughbred horses with osteoarthritis, 89.6% showed a reduction in lameness after the treatment, while 72.4% demonstrated complete resolution of lameness four weeks later. Allegro plans to publish the results of the study at a leading medical conference in 2026. The company is also announcing today it has received approval from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium for an open-label feasibility study with its Hydrocelin hydrogel device candidate in 20 patients with osteoarthritis of the knee. Allegro expects to launch the study in the coming weeks. "These first efficacy results in horses using Allegro's osteoarthritis treatment candidate suggest extraordinary promise for use in humans. Osteoarthritis is the leading cause of disability in humans, with no disease-modifying treatment available today. At Allegro, we're working to demonstrate benefits to patients in our clinical testing this year, and offer better outcomes for the 650 million people affected by the disease," said Lucas Decuypere, CEO of Allegro. Horses are a strong translational model for humans in joint disease and Allegro is fully focused on the clinical development of its technology, after signing an exclusive licensing deal for its technology for use in veterinary markets with American Regent, a leading pharmaceutical company in the U.S. specializing in injectables for human and animal health. Allegro will supply American Regent with product from its manufacturing site in Belgium. In the study, horses received a single injection of the hydrogel in the most affected joint, and hyaluronic acid (Optivisc Single) in the contralateral (healthy) joint as a control. Among the findings were: * After four weeks of treatment with Allegro's hydrogel, 89.6% of horses (26 out of 29 evaluable horses) showed improvement of the AAEP lameness score, while 72.4% (21 out of 29 evaluable horses) showed complete resolution of lameness. * The difference in the AAEP lameness score after 4 weeks of treatment compared with the score before treatment was statistically significant (p<0.05). * No adverse effects were observed in pathological joints after the nanogel injection and throughout the 4-week follow-up period. Hydrocelin contains cross-linked particles designed to act as tiny shock absorbers in the synovial fluid. Restoring the shock-absorbing capacity of the synovial fluid is intended to provide pain relief and protect cartilage in the joints. In April, Allegro presented positive preclinical data demonstrating the satisfactory safety profile of Hydrocelin at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO) in Rome. In addition to this pyrogenicity study, the company has also demonstrated a satisfactory safety profile in preclinical studies assessing irritation, delayed sensitization and systemic toxicity. Allegro NV (www.allegro.bio) is a clinical-stage biomedical company developing transformative treatments for degenerative joint diseases based on its proprietary nanotechnology platform, INTRICATE. The company's lead product candidate, Hydrocelin, is a first-in-class, potentially disease-modifying injectable treatment for osteoarthritis, a novel performance biomaterial designed to restore the natural protective mechanics of the joint - rather than merely masking symptoms. By altering the trajectory of the disease at its source we aim to redefine the future of osteoarthritis and its care. | For further information please contact: Allegro NV Lucas Decuypere Chief Executive Officer email [email protected] | Investor Relations Mary-Ann Chang Cohesion Bureau +44 7483 284 853 [email protected] Media Relations Douwe Miedema Cohesion Bureau +352 621 562 764 [email protected] | Important information The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
OrthoTrophix partnered with American Regent, Inc. (https://americanregent.com/) on its DMOAD candidate, TPX-100, for the U.S. market and retains the rights for the rest of the world.
American Regent expanding pharmaceutical production facility in New Albany.