Process Validation-Support of late-stage development and process validation, CMC Biologics.

Found in: beBee S DK - 4 weeks ago

Valby, Denmark Lundbeck Pharma AS Full time

Process Validation Support of late-stage development and process validation, CMC Biologics.  

As a Validation Responsible, you will serve as a subject matter expert (SME) and support the development and implementation of the validation strategy for biologics production including Upstream Cell Culture Production, Downstream Processing, or Drug Product Manufacturing. You will be engaged in late-stage clinical development and validations before commercial manufacturing. You will work in close collaboration with colleagues across the organization, as a member in our multidisciplinary project teams and in close contact with our network of global Contract Manufacturing Organizations (CMOs). Specifically, this role has responsibilities for developing and generating documents such as validation plans, protocols and reports. 

Your job and key responsibilities in CMC Biologics will involve: 

Development of validation plans, PPQ protocols and reports for commercial manufacturing in alignment with GMP quality system documentation standards. 

Ensure all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training. 

Technical lead and subject matter expert for Biologics Manufacturing. 

Work in close collaboration with project team (including QA) and CMOs, to plan and perform validation activities, in accordance with regulatory requirements and company policies. 

Being person in plant at CMO during validation activities, to identify and mitigate risks, to transfer technology and know-how, and to contribute to complex and critical deviations, changes, and process improvements. 

Supporting regulatory filings and other interactions with Health Authorities. 

Facilitate internal transfer of product from CMC into Commercial Production, including writing first protocols for Continued Process Verifications 

Collaborate with Process Development colleagues in project teams, to assist define timing and content of studies Validation studies during clinical and commercial manufacturing. 

Collaborate with clinical manufacturing as well as support functions such as Process Engineering and Quality to provide support to clinical manufacturing. 

Work with multi-functional teams conducting FMEAs, risk assessments, author technical protocols, reports, and CMC subsections. 

This position is a great development opportunity where you will be part of defining future manufacturing strategies of biologics within Lundbeck and work in an exciting interphase with various internal and external stakeholders. 

Your future team 

In CMC Biologics we are more than colleagues, split between Lundbeck Headquarters in Copenhagen and Lundbeck Center of Excellence in Seattle. Most of the CMC Biologics organization has employees based in both Copenhagen, Denmark and Seattle, US. This is also the case for your new department, Process Science & Validation, where the split is close to 50/50 between the two sites. You will work out of the headquarter in Valby, Copenhagen, and will report to the Director for Validation, in Seattle. 

Your colleagues in the Validation team are all experienced Validations specialists, and together you will cover Drug Substance, Drug Product, and transportation Validation for all Lundbeck biologics projects. 

In Lundbeck, we strive to develop new innovating treatments to improve the lives of patients living with brain diseases. CMC Biologics support the development and production of new Biologics drug candidates for diseases like Migraine, Parkinsons, and Alzheimers. Established CMC Biologics focus teams and working groups are responsible for the continued development of Lundbecks Biologics candidates and are working into global project teams with representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, and Commercial. 

Some travelling will be expected in this role, although not so frequent for the validation team. As mentioned, our team is located both in Copenhagen and Seattle, and we therefore have focus on reducing late meetings via maintaining a primary meeting band in the calendar and via applying a geographical proximity, when working with our global CMOs. 

What you bring to the team 

You hold aBachelor of Science, Master or PhD in engineering, chemistry, biological science or equal. Preferably you will have 4+ years in Biotechnology or Pharmaceutical Development and 1+ years of direct experience in Process Validation as well as experience from working with CMOs. Your experience withing pharmaceutical development could either be from Drug Substance and/or Drug Product. Any experience with Transport Qualification will also be appreciated. 

Furthermore, you have the following skills: 

Knowledge of cGMP requirements, regulations, and guidelines. 

Fluently in English (Danish will be a benefit but is not a must). 

A team player with a positive attitude and the ability to work effectively in matrix teams in a dynamic environment.

Good communication and stakeholder management skills when representing the Validation team in cross-functional and cross-site teams and with CMOs. 

Empowered, with the ability to plan and proactively handle multiple tasks simultaneously. 

Experienced with working in an international setting with different cultures.

Candidates fulfilling most but not all the listed qualifications are still encouraged to apply, as the position can be adjusted according to qualifications. We are planning to hire more than one Validation SME, covering both a Sr. Scientist and a Sr. Specialist. 

Our promise to you 

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative a must to bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being. 

Applynow 

Can you see yourself as our Validation Engineer and want to join our international team of Validation Experts? 

Then upload your CV and include your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience. 

Applications must be received by March 17, and will be reviewed on an ongoing basis. 

#EveryBrainInTheGame 

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

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