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Technical Leader Biologics

Do you want to contribute with strong knowledge and make a change within protein therapeutics?


Your new company

Zymenex is engaged in the research and development of innovative therapeutics for life threatening diseases. It is a Scandinavian biopharmaceutical company focused on the development and commercialisation of novel enzyme replacement therapies for the treatment of life-threatening, rare genetic diseases. Zymenex is developing several human recombinant enzymes that can be used for therapy within specific disease areas. The products are expected to be able to help patients, who today have serious handicaps, reduced quality of life and a markedly reduced life expectancy. Enzyme replacement therapy is a well-known treatment method and there are a number of products on the market today that validates the company concept. The company’s Research and Development focuses on Lysosomal Storage Diseases, which is a common name for human diseases, where the ability of the human body to break down specific molecules in the lysosomes in the cells is reduced or impaired. The diseases most often affect children, they are lethal and there is no therapy available today. Zymenex was established in 1998. The organization has broad experience from positions in other pharmaceutical companies and competencies spanning from research and development to production and marketing of pharmaceutical products. The company has built its portfolio of product candidates and manages the development process based on own competencies, supplemented by outsourcing.


Your new role

The successful candidate will be responsible for leading the Company’s outsourcing activities related to the manufacturing of investigational medicinal product. This role will be responsible for the scouting and selection of new service providers (CMOs and CROS), the planning and execution of technology transfers from the Company’s research and development teams as well as the management of daily outsourcing activities during all development stages to secure the proper supply of phase-appropriate investigational material. Furthermore, the role is expected to be instrumental in the hand-over of the processes to the commercial manufacturing organization when market authorization has been accomplished. To accomplish this it is important that the ideal candidate understands the importance of proper project management and communication both internally and externally. The individual should have longstanding experience in bulk Drug Substance process development, validation and manufacturing related to recombinant proteins. The ideal candidate must be comfortable working independently in a small company environment while managing communication and collaborations with a larger parent company as well as external service providers to support the Company’s drug development and manufacturing activities.

Responsibilities and Accountabilities:
To lead the Company’s scouting and selection of new CMOs and CROs.
To manage the technology transfer of in-house developed manufacturing processes and related analytical packages to external parties.
To manage the outsourcing activities throughout all clinical development phases both towards internal and external stakeholders.
To actively participate in regulatory validations both on national and centralized levels i.e. EMA and FDA.
To achieve proper quality documentation to support clinical trial applications and market authorization applications.


What you'll need to succeed


Education:
Preferably a PhD in Chemical/Biochemical Engineering, Biochemistry, Process Science or related.

Experience:
Minimum of 10 years of industrial experience from the biopharmaceutical industry with an established reputation of expert knowledge in recombinant protein manufacturing and validation (either UpStream or DownStream). Highly experienced in leading and managing internal and external activities, resources and stakeholders. It is beneficial with proven experience from regulatory interactions with EMA and FDA.

Essential Skills:
Longstanding experience in managing outsourcing activities related to manufacturing and characterization of protein therapeutics in clinical development.
In-depth knowledge of all aspects pertaining to UPS and DSP process development at an industrial level.
In-depth understanding of the regulatory requirements for development and industry standard for cGMP manufacturing of protein therapeutics.
Direct experience from regulatory interactions related to CMC preferably with EMA and FDA.
Proven experience with CMOs and CROs.

Personal skills:
Strong leadership and problem solving skills.
An effective communicator with excellent project management skills.
Results driven, in a fast-paced environment in order to meet projects timelines.
Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment.


What you need to do now


If you're interested in this role, click 'apply now' to forward an up-to-date copy of your resume and personal letter in one document (word-format) as soon as possible. Interviews are on an ongoing basis. If you have questions, please contact Senior Recruitment Consultant Kristina Edholm on +46 (0)704 50 60 14. I do look forward to receive your application!


Sammanfattning

Jobbtyp:
Rekrytering
Industri
Vetenskap & forskning/utveckling
Ort
Stockholm
Specialisering
Life Sciences
Ref:
896933
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Tala med Kristina Edholm, specialistkonsulten som hanterar denna position, i Stockholm

Hays, Sturegallerian, Stureplan 4C, Stockholm, Stockholm, 114 35

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