Senior Manufacturing Formulator

Senior Manufacturing Formulator Senior Manufacturing Formulator collaborates to produce reliable medical device products and supplies with effective operations in an empowered organization. As part of a dynamic team, the Senior Manufacturing Formulator performs weigh, mix, and in process testing of chemical reagents in a regulated environment, through the manual processing or operation of automated equipment. Additionally, the role supports production by proactively recognizing, and elevating safety, equipment, and product‑related issues, contributing to the achievement of production goals. Responsibilities Utilize validated software systems to maintain processes, batch records, and inventory control, ensuring all production related documentation is in compliance with quality system regulations. Train new employees, share best practices, and ensure team members are qualified to perform the work. Influence, motivate, and provide guidance to team members, serve as back‑up Process Lead, and communicate and collaborate with leadership as needed. Identify opportunities that drive the business forward while complying with quality processes and objectives. Act as subject matter expert in the formulation and production of stocks and bulk solutions by performing calculations, completing material requests and transactions, and utilizing lab equipment in controlled areas. Identify improvements to improve cycle time, quality, safety and delivery of products. Perform in‑process testing of reagents as detailed in manufacturing formulas, troubleshoot and develop standard operating procedures. Support team members with verifications including concentrations/titers, line clearance, and line closeout. Check open reservations, request material, pull material aliquot, and properly label material to fulfill reservations. Plan, input, and execute validations, protocols, and scientist investigations. Initiate and lead process improvement projects. Contribute to the manufacturing schedule by supporting at least three reagent product lines (detection, molecular, special stains, antibody, bulk reagents). Serve as subject manager expert in validated production systems as part of manufacturing documentation and inventory management. Communicate and collaborate with planning, quality control, material conveyance and other production teams to expedite work. Partner with Process Lead to understand and execute production schedule; ensure daily end‑of‑shift reports/pass‑downs are completed to maintain communication and synergy between shifts and teams. Assist with batch record reviews. Maintain Right to Operate and ensure all processes are performed in a safe and healthy manner; address and escalates any potentially unsafe hazards. Report safety hazards, incidents, and near misses using safety reporting tools promptly. Recognize and initiate safety improvement projects, communicating with and partnering with SHE group and Leadership to implement. Ensure audit readiness (OSHA, NMPA, FDA, etc.); represent the team during internal audits/inspections as required. Perform and document all transactions and production instructions with accuracy related to the receipt, quarantine, storage, and disbursement of materials as it relates to FDA, OSHA, QSR, ISO, Good Manufacturing Practices and other Roche policies and procedures. Escalate all quality and production deviations to leadership. Lead and own non‑conformance investigations, reworks, and corrective actions. Own, initiate, monitor, review, and provide feedback on document changes, including redlines. Adhere to 95% or above internal training compliance. Maintain calibrated equipment, assess the need for new or replacement equipment, and coordinate purchase and IOQ/certification process. Collaborate proactively with peers on shift and with other functions to exceed daily targets. Assist in onboarding new employees and contractors, facilitating on‑the‑job training. Collaborate with leaders to maintain and cultivate the organization’s culture. Partner with internal and external functions to address escalations in a timely and effective manner. Collaborate with cross‑functional teams on new production processes as needed. Act as subject matter expert in 6S activities; identify, own and implement process improvements and continuous improvement initiatives utilizing lean tools. Collect and trend daily metrics (e.g., safety, quality, cost, delivery) to identify gaps and support operational excellence initiatives and improvements. Identify areas for improvement and convey ideas to maintenance, engineering, or area leaders. Troubleshoot problems, engage appropriate support functions, and assist in implementing preventative measures. Qualifications Associate’s degree plus 3 years of work experience required. Bachelor’s degree plus 2 years of experience preferred. Experience in a regulated industry required. Experience in GxP required. Pay and Benefits Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of Tucson is 49,800.00 – 92,400.00 USD annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. EEO & Accommodations Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr F. Hoffmann-La Roche AG