Process Expert

Job Description Summary

At Advanced Accelerator Applications a Novartis company we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals.

The Process Expert will provide front line technical and scientific expert support for all processspecific issues to ensure of processes ontime (business continuity) in compliance to cGMPs SOPs and applicable guidelines and functional standards (e.g HSE) and to allow continuously improving in quality productivity efficiency.

Job Description

Major accountabilities:

Operational Activities:

Provide front line expert support for all processspecific issues to production

Act as Subject Matter Expert (SME) for the product and process

Support manufacturing to ensure the completion of all production operations on time in accordance with the documentation and in compliance with GMP SSE and 5S rules

Ensure real time shop floor support as an expert on technical problems and ensuring that appropriate immediate corrective/remediation actions are implemented.

Perform real time batches followup and batch records technical review

Ensure that all production documents are systematically up to date and that the production documents necessary for the validation / revalidation of processes are available

Execute validations when/where needed

Manage the preparation and of changeover activities between campaigns by ensuring availability of equipment consumables raw materials documentation and providing Change Over training to technicians

Transfer of information and increase awareness of production teams following problems or modifications having a technical quality or HSE impact

Develop technical and scientific knowledge of shop floor technicians

Conduct training to ensure process knowledge for operators

Support the T&L organization in defining and maintaining appropriate qualification criteria for inscope areas of expertise

Support the T&L organization in defining and maintaining training to support associates achieving qualifications

Deliver instructorled training for areas of inscope expertise

Promote Quality and HSE culture on the shop floor

Compliance Activities:

Ensure timely treatment of deviations complaints OOE OOS and the implementation of effective CAPs within the agreed timelines.

Lead thorough Root Cause Investigation process using investigation tools and methodology.

Support Validation Experts and Product Stewart with process deviations

Ensure that all process changes in assigned products are managed through appropriate change control procedure

Support Validation Experts and Product Stewart regarding the definition of the validation strategy

Prepare support and followup of Health authority and internal inspections

Support Regulatory Compliance QA for dossier submissions revisions...

Ensure the management of all validation revalidation / qualification / Annual Monitoring Batch (AMB) respecting deadlines and current regulations

Support Product Stewart in setting up and monitoring trends within the framework of the CPV (Continued Process Verification) and corresponding actions

Provide input to APQR and OPV for analysis and for driving process technology Innovations

Ensure implementation and maintenance of the quality systems with the site in accordance with corporate and regulatory guidelines

Ensure consistent interpretation and implementation of QMs and GOPs on local site level

Provide compliance oversight for GMP on site

Monitor quality systems provide trend reports for customer and management use

Responsible for the GMP documentation of the manufacturing unit

Responsible for creating and maintaining the master manufacturing documents of assigned products

Ensure timely and routinely reporting of trending and evaluation reports

Provide support and oversight of all site activities related to 3rd parties keep oversight of contractors suppliers and service providers

Act as point of contact for platform and NTO compliance support global initiatives as assigned represent site at global

Ensure quality oversight of all qualification and validation activities (i.e. instrument and equipment qualification CSV and local ecompliance)

Provide risk / gap assessments determine effectiveness of related remediation actions

Drive the site collection monitoring evaluation and reporting of the site Quality KPIs

Operational Excellence & Continuous Improvement Activities:

Lead continuous improvements projects in collaboration with Product Stewart and in compliance with cGMPs SOPs applicable guidelines

Participate in continuous improvement and productivity projects

Provide support to teams for the implementation of improvements actions 5S the exploitation of production data and the implementation of controls charts

Actively participate in the development of production staff in the continuous improvement process

Provide operational support to teams during technology transfers

Ensure the management of the various projects: coordinate the stages defined in the projects and ensure timely completion and compliance with cGMPs and HSE

Conduct risk analysis ensure the drafting of documents production and validation on time ensuring the management of activities related to any modification of existing facilities in collaboration with stakeholders in the case of transfer of a new process or major modifications to existing processes

Define the technical needs to achieve the strategic objectives of the production and prepare in cooperation with engineering the feasibility study as well as the corresponding budget

Author technical documents defined in the projects

Support Engineering in URS for new equipment/investments in general

Actively participate in the definition and writing of technical specifications

Quality & HSE Activities:

Promote and improve the Quality culture in collaboration with Quality Assurance.

Collaborate with Quality Assurance in the improvement of Quality by initiating organizing and checking the practical application on the shop floor

Ensure overall inspection readiness for area of responsibility

Be responsible for the compliance to the principles and practices described in the Novartis Manufacturing Manual and their implementation on the site for his area

By delegation of the Manufacturing Unit Head may be required to take decisions and take the necessary actions in particular within the framework of the oncall management system

Participate to in collaboration with the HSE Lead the upgrade and improvement of the HSE by checking the practical application in his team

Promote and improve the HSE culture by implementing the necessary systems and actions in line with the evolution of the site

The pay range for this position at commencement of employment is expected to be between $77000 to $143000/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a signon bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Minimum Requirements:

BSc. in Chemistry Pharmacy Chemical Engineering or Pharmaceutical Technology.

2 years of relevant experience in GMP environment.

Previous pharmaceutical experience.

Thorough understanding of manufacturing processes and related process equipment.

Experience in writing technical documents.

Experience in executing validation documents.

Radiopharmacy experience is preferred.