DP MSAT Senior Specialist

This role supports the transition of pharmaceutical processes into commercial manufacturing by leading technology transfer, validation and regulatory readiness. It involves managing quality documentation, investigating deviations, authoring SOPs and risk assessments, and ensuring process verification for commercial products - all in close collaboration with internal teams and external manufacturing partners. Additionally, the role includes training and coaching responsibilities. Key Responsibilities: Managing transition of new development processes into late stage-commercial manufacturing by working with PTM and subgroups. Work as PTR with PTM and subgroups for technology transfer, validation activities and PPQ. Support external/CMO manufacturing activities.

Responsible for quality documents during the batch (clinical/PPQ/commercial) i. e. , process related deviations/change control/CAPA and OOS/OOT/OOR Phase II investigation. Be an SME author of Deviations, CAPAs and change controls relating to DPM processes. Be an SME author/reviewer and/or approver for written procedures, SOPs, protocols, comparability protocols, sample plan and reports etc. Be an SME for the transport validation and authoring of validation protocols and reports and execution of validation. Be an SME author for performing risk assessments relating to DPM processes.

Be an owner for continued process verification (CPV) activities for advanced commercial programs. responsible for addressing the regulatory queries, dossier update and review for the new projects. Be an owner for Continued Process Verification (CPV) activities for advanced commercial programs. Responsible for post PPQ phase activities like CPV protocol and report and E&L assessment reports. Responsible for New process trainings. As a Trained Trainer, train, coach and mentor. Help to provide guidance and support team members. Responsible for development of single use systems based on the process requirements. Qualifications: Master's degree in a relevant field (e. g.

, Biotechnology, Engineering, Pharmaceutical Science). 5-10 years of relevant experience. Ability of writing protocols and report the technical information in written and verbal format. Basic knowledge of visual inspection guidelines and practices. What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change people's lives. The chance to be a part of a global and fast-growing company. An international work culture that encourages diversity, collaboration and inclusion. Positive, flexible, and innovative work environment. Support for personal growth and internal career development. Company social events and milestone celebrations. Excellent in-house canteen and coffee house.

Exercise and wellbeing support for full-time employees. On-site shower facility. Transportation grant towards eco-friendly modes of travel for full-time employees. Internet at home for full-time employees. Why AlvotechAt Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.