Manufacturing Business Applications Manager

Nature and Scope

The Manufacturing Business Applications Manager will lead the strategy, design, deployment, governance,technical support, and continuous improvement of manufacturing business applications supportingpharmaceutical manufacturing operations across all American Regent, Inc. sites. This role owns a portfolio ofdigital manufacturing capabilities-including Manufacturing Execution Systems (MES) with electronic batchexecution workflows and OEE/KPI performance reporting solutions-and serves as the primary link betweenManufacturing, Quality, Engineering, IT, and Operational Excellence teams.

The role is responsible for enabling compliant, data-driven, and increasingly digital manufacturing processes,moving the organization beyond current paper-based execution toward standardized, scalable, and integrateddigital solutions. The ideal candidate will ensure manufacturing applications deliver value in shop floor execution,batch documentation, performance visibility, quality, traceability, and continuous improvement, while supportingregulatory compliance and operational excellence.

Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to thisjob at any time.

• Technical ownership and lifecycle management of core manufacturing business applications, includingMES platform with electronic batch execution workflows and OEE/KPI performance reporting solutions,within a regulated pharmaceutical manufacturing environment.

• Lead and govern the selection, design, implementation, optimization, and sustainment of digital batchexecution, replacing current paper-based records with compliant electronic workflows.

• Enable real-time and historical OEE, KPI, and manufacturing performance reporting, ensuring dataaccuracy, consistency, and usability in support of Lean manufacturing and Operational Excellence (OpEx)initiatives.

• Drive digitalization of pharmaceutical manufacturing processes, including shop floor workflows, datacapture, deviation handling, production reporting, and continuous improvement activities.

• Partner with Manufacturing, Quality, Engineering, Supply Chain, IT and OpEx/Lean teams to align digitalsolutions with operational, quality, and performance improvement objectives and IT architecture,cybersecurity, and data integrity standards.

• Ensure systems are designed and maintained to comply with FDA regulations and GxP requirements,including 21 CFR Part 11, data integrity (ALCOA+), and CSV/CSA expectations.

• Oversee integrations between manufacturing applications and enterprise systems such as SCADA, ERP,CMMS, LIMS, and supply chain platforms, enabling end-to-end data flow.

• Develop and maintain a manufacturing applications roadmap aligned with digital manufacturing, Lean,and new Industry 4.0 initiatives.

• Support change management, training, and user adoption to ensure sustained value realization frommanufacturing digital solutions.

• Manage vendors, system integrators, and internal support resources.

• 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. Therequirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or other STEM related field required.

• 10+ years of technical ownership of manufacturing business applications in a regulated pharmaceutical,biotechnology, or life sciences manufacturing environment required.

• 10 + years of expertise in GxP regulations & requirements, including 21 CFR Part 11, Annex 11, dataintegrity (ALCOA+), and CSV/CSA expectations required.

• Demonstrated expertise in pharmaceutical manufacturing processes, including batch execution, shopfloor control, and material inventory traceability.

• Hands-on experience driving digitalization initiatives, including replacement of paper-based processeswith compliant electronic MES, Electronic Batch Records workflows, and manufacturing performancesystems (OEE/KPI reporting) solutions.

• Experience integrating manufacturing applications with SCADA, ERP, CMMS, LIMS, and supply chainsystems.

• Proven ability to partner effectively with Manufacturing, Quality, Engineering, IT, and OpEx teams.

• Experience with leading MES platforms (e.g., Werum PAS-X, Siemens Opcenter, Emerson Syncade, orequivalent).

• Experience supporting FDA inspections and audit readiness related to manufacturing systems.

• Prior experience managing vendors, system integrators, and cross-site implementations.

• Working knowledge of Lean Manufacturing and Operational Excellence (OpEx) principles and how digitalsystems enable continuous improvement. Familiarity with Industry 4.0/Smart Manufacturing, advancedanalytics, and digital strategy and manufacturing technologies.

Physical Environment and Requirements

• Remote role with up to 25% travel to all locations within the organization.

Expected Salary Range:

$120,000-$140,000

The salary range, displayed is the minimum and maximum annual salary range 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.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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