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Analytical Leader Biologics


Your new company


Zymenex is engaged in the research and development of innovative therapeutics for life threatening diseases. It is 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 lead the analytical development activities related to protein therapeutics, defining and delivering analytical product development strategies and outcomes for the Company’s protein therapeutic candidates from the internal pipeline and from third party collaborations. The individual should have longstanding experience in developing, qualifying and validating analytical methods for the purpose of characterizing 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 outside contractors to support the Company’s drug development and manufacturing activities.


What you'll need to succeed

Education:
Preferably a PhD in Analytical Chemistry, Pharmaceutical Chemistry, or Biochemistry.

Experience: Minimum of 10 years of industrial experience in the development and validation of analytical methods for the purpose of characterizing proteins. Well experienced in leading and managing internal and external activities and resources.

Primary Duties and Responsibilities:
Lead, design and execute activities both in-house and externally at CRO/CMO from early discovery phase and all the way up to commercial registration.

Responsible for be the development, qualification and validation of analytical methods suitable for characterization as well as release and stability analysis during clinical development.

Preferably the ideal candidate has proven expertise in development and validation of cell-based assays such as potency assays and drug-specific immune assays to be used for analysis of in vivo immune responses.

Familiar will regulatory requirements related to drug development to ensure that the appropriate characterization of protein therapeutics is achieved to support regulatory filings for clinical trials and for market registration.

Responsible for all scientific, strategic, and project planning and execution aspects of biologic analytical development activities, based on organizational goals and project timelines.

Responsible for establishing and maintaining high scientific and technical standards within the company and for all development activities.

The person will assist in evaluation, selection, and management of CRO/CMO organizations and make recommendations as to their suitability for analytical development and/or contract manufacturing.
 
The ideal candidate must be results driven and be able to take independent decisions to achieve timely delivery of activities and projects.

Essential Skills:
An established reputation of expert knowledge in Analytical Development related to biologics, with a demonstrated track record supporting clinical/commercial programs for protein therapeutics, including filing of INDs/IMPDs and MAAs/BLAs is preferred.

An in-depth understanding of the regulatory requirements for development and industry standard for cGMP manufacturing for protein therapeutics is essential.

Direct experience in authoring, submitting CMC regulatory documents and participating in meetings with regulatory agencies to support clinical development and US/EU marketing approval.  

The ideal candidate must have proven experience with contract manufacturing organizations (CMOs).

This position requires strong leadership and problem solving skills as well as excellent communication skills. The candidate must be results driven, in a fast-paced environment to meet projects timelines.

Established and demonstrated project management skills in order to develop and execute cGMP analytical activities internally and externally.

Effective communication with Zymenex company management and with parent company Chiesi’s headquarter stakeholders (Quality, Regulatory CMC, Global Manufacturing, Project Leadership, Business Development, Commercial, and Clinical organizations) is required.

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/kristina.edholm@hays.com. I do look forward to receive your application!


Sammanfattning

Jobbtyp:
Rekrytering
Industri
Vetenskap & forskning/utveckling
Ort
Stockholm
Specialisering
Life Sciences
Ref:
896934
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Tala med en konsult

Tala med Kristina Edholm, specialistkonsulten som hanterar denna position, i Stockholm

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

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