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Salary
$90k – $105k per year
Location
In office (Shirley)
Seniority
Middle · 4+ years exp
Visa
H-1B filings in 12 months: 3 · green card filings: 1
Employment
Full-Time

Confirmed on the employer's own hiring board on Nov 9, 2026. First seen by Alion on Sep 3, 2026. American Regent scores B on the Alion truth index.

Overview
Company
Impact
Profile match
American Regent is a US pharmaceutical company based in Shirley, New York, that develops, manufactures and supplies branded and generic sterile injectable medicines, including the IV iron therapy Venofer, trace element and phosphate injections. Founded in 1967, it merged into Luitpold Pharmaceuticals in 2019 and took the American Regent name, belongs to the Daiichi Sankyo group and also runs an animal health business with joint health products for horses and dogs. It hires filling and compounding operators, QC environmental monitoring technicians, validation and process engineers, QA staff and production supervisors for its plants in Shirley and in New Albany and Hilliard, Ohio.

Nature and Scope

Provides direct supervision and leadership to assigned training personnel responsible for operational training, on-the-job training, workforce qualification, and training-related quality support across assigned functional areas. Establishes priorities, assigns and monitors work, evaluates performance, coaches and develops staff, and ensures consistent, effective execution of training activities. Holds training personnel accountable for maintaining accurate documentation, qualification controls, regulatory compliance, and timely delivery of business-critical training. Partners cross-functionally to ensure employees are trained, qualified, and released to perform work in accordance with business needs, internal procedures, and applicable regulatory expectations.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

  • Directly supervise and lead assigned training personnel, including establishing performance expectations, assigning and prioritizing workloads, monitoring work quality and completion, providing ongoing coaching and timely performance feedback, addressing performance or conduct concerns, supporting development and succession planning, and fostering accountability, collaboration, and continuous improvement within the training team.
  • Oversee operational training programs that support employee readiness across assigned functional areas, partnering with department leaders and SMEs to align training requirements with current procedures, job tasks, equipment, process changes, operational priorities, and regulatory expectations.
  • Implement and maintain OJT and job/task qualification processes, including qualification requirements, OJT checklists, practical evaluations, skill signoffs, qualification evidence, training-documentation controls, release-to-work controls, and trainer/evaluator qualification activities.
  • Oversee the day-to-day execution of operational training delivery, cross-training, practical qualification, trainer support, and learner progression in partnership with learners, trainers, evaluators, supervisors, managers, and subject matter experts.
  • Track workforce readiness, including training completion, qualification status, overdue OJT, task restrictions, cross-training progress, and related risks; escalate concerns that may affect operations, quality, safety, inspection readiness, or an employee’s release to perform work.
  • Create, revise, and maintain training materials, job aids, assessments, curricula, and related learning resources and assignments to support approved procedures and operational requirements.
  • Support deviations, CAPAs, quality events, audit observations, inspection requests, and performance concerns by reviewing training history and qualification evidence, identifying training or qualification gaps, recommending corrective responses based on root cause and risk, and tracking assigned training commitments to closure.
  • Monitor training effectiveness, KPIs, and qualification trends to identify systemic risks, performance gaps, and improvement opportunities.
  • Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

  • Bachelor’s Degree or equivalent combination of education and relevant experience, required.
  • Minimum of four years of relevant experience in training within operations, manufacturing, quality, laboratory, pharmaceutical, biotechnology, medical device, or another regulated environment required.
  • Experience with operational training, OJT, workforce qualification, practical skills assessment, training documentation, and employee-readiness tracking preferred.
  • Working knowledge of GMP, quality systems, training-documentation expectations, and applicable regulatory and safety requirements, including 21 CFR.
  • 1 to 3 years of leadership experience including and/or has demonstrated success the ability to lead, coach or mentor a team or group required.
  • Demonstrated experience directly supervising, coaching, mentoring, and developing training personnel including assigning and monitoring work, setting expectations and delivering performance expectations.
  • Strong organizational, communication, documentation, follow-up, coaching, problem-solving, and cross-functional collaboration skills.
  • Ability to maintain access to aseptic processing areas, including gowning and aseptic qualifications.

Expected Salary Range:

$90,000-$105,000

The salary range,displayedis the minimum and maximum annual salary of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:

·All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.

·Our recruiting process includes multiple in person and/or video interviews and assessments.

·If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.

·We never request payment, bank information, or personal financial details during our offer process.

Your security is important to us, and we encourage you to stay vigilant when job searching.

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [email protected].

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