Senior Scientist, Process Transfer and Validation

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Senior Scientist, Process Transfer and Validation

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.

An exciting and diverse career opportunity awaits you in our Process Transfer & Validation Department in Copenhagen. Do you enjoy bioprocesses and being challenged by different scientific questions? Then this might be the job for you.

The Team

The Process Transfer & Validation (PT&V) Department consists of three specialized teams: Early-Stage Process Transfer and Validation, Late-Stage Process Transfer and Validation and Material Science.

About the Role

The Senior Scientist, Process Transfer and Validation (PT&V) is part of a diverse and inclusive team , which is responsible for the introduction of new projects to AGC Biologics through Technology Transfer from clients or from other sites to AGC Copenhagen, up to the validation and monitoring of process in commercial phase. They support GMP manufacturing operations, oversee process design, ensure continuous process improvement, oversee changes in the process and drive risks assessments, validations and process monitoring.

Your Primary Tasks Will Include.

• Act as project /process owner for multiple late-stage projects , as well as for internal processes /projects.

• Lead activities to transfer processes to Manufacturing from internal AGC Process Development or directly from customers.

• Validate (Process Performance Qualification - PPQ) and monitor (Continued Process Verification - CPV) processes, including the validation of mixing and hold times (M&H) of solutions and intermediate products.

• Work with clients on process mapping and scale-up of manufacturing processes .

• Participate and /or take a coordinator role in internal and client project team meeting s .

• Perform process and other risk assessments (e. g. , Extractables and Leachables, Elemental Impurities, Nitrosamines, Shipping, Cleanability, Raw Material assessments), manufacturability assessment, scale up and dimensioning for newly transferred process.

• Participate in audits and inspections covering topics related to owned projects and general PT &V procedures .

• Support manufacturing operations prior, during and after batch execution to ensure batch success and continuous improvement. Prepare and present data associated with manufacturing processes to internal and external clients.

• Provide training and mentorship to new Process Transfer and Validation scientists.

• Participate in the project team meetings, decisions, and creation of milestones representing PT&V . Prepare data analysis and draft solutions to support decision-making processes.

• Act as SME in relevant areas (Fermentation, Harvest, Chromatography, Filtration, Raw Material, Safety , M&H Validation, Risk Assessments, PPQ, CPV, etc. ).

Your Qualifications.

• BSc with 6+ years, or MSc with 4+ years or PhD with 2+ years of relevant experience from the pharmaceutical industry working in a cGMP environment.

• Education in the fields of Biochemistry, Chemistry, Biology, Bioprocess Engineering , Pharmacy, Biotechnology or other relevant discipline.

• Equivalent education and experience may substitute for stated requirements.

• Must have demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations.

• Must have experience writing, reviewing and approving GMP documentation.

• Skilled in using Microsoft Excel , PowerPoint , Visio and Word.

• Expertise in Upstream bioprocessing and/or expertise in Downstream bioprocessing and/or validation activities.

• Good verbal and written communication skills in English, being able to adapt the style to differing audiences.

• Able to adapt to changes.

• Experience with Tech Transfer and/or Process Validation in a few different projects , being able to evaluate different scenarios/data, beyond standard procedures and with limited information, to design solutions for diverse type of issues.

• Familiarity with interdependencies of late-stage activities and requirements for successful PPQ campaigns. Ability to assess the impacts of complex changes to the validated state of the process.

Preferred

• Expertise in Upstream bioprocessing with experience in Tech Transfer.

• Application of statistical knowledge towards the interpretation of data using software, such as SAS JMP.

• A minimum of one-year experience in Process Validation (including process risk assessment and PPQ) is desirable.

• Good understanding of Quality Risk Management.

Application

• To apply, please submit your CV. We encourage you to apply, even if you do not meet every requirement.

• We continuously evaluate incoming applications and conduct interviews accordingly. Therefore, please submit your application and CV as soon as possible.

• If we see a potential match, one of our recruiters will contact you to discuss your application.

• For more information, please contact the Willer Ferreira, Senior Manager, Late stage Process Transfer & Validation on

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U. S. , Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Bio.