Head of Analytical Developement, Europe (gn)

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Wien, Österreich | 
Permanent
Job title: Head of Analytical Developement, Europe
Duration of employment: Unlimited
Industry: Pharma
Skills: Analytical Development, Quality Control, ICH-GCP
Location: Vienna, Austria

Tasks:
  • Lead a team of managers, scientists and their teams in analytical development in the field of biologics and gene therapy.
  • Monitor and manage phase-appropriate analytical development for clinical trial material efforts with three focus areas:
    a) characterisation and comparability,
    b) method development of methods for non-routine and release/stability use,
    c) method development for in-process analytics across all required analytical techniques (including but not limited to HPLC, mass spectrometry, immunological and potency assays).
  • Contribute to product development from research to commercialisation, collaborating with multiple functions within the Pharmaceutical Science organisation to enhance analytical, process and product knowledge.
  • Transfer development resources from research and handover to the commercial organisation
  • Contribute to the overall functional direction and represent the function within CMC/Pharmaceutical Science and across the global organisation.
  • Implement and execute externalisation activities with external partners, support the development of execution plans and ensure completion of agreed activities.
Accountabilities:
  • Direct and indirect supervisory tasks in analytical areas for the development of high value biological therapeutics (proteins, gene therapy, peptides).
  • Data compilation and review; preparation and review of technical reports, regulatory filings and other documentation; representation/leadership of project/CMC team; technical interactions with internal partners and contract laboratories.
  • Collaborate with other functions in Pharmaceutical Sciences to promote strategic alignment and successful achievement of common goals and objectives
  • Experience with all phases of analytical development and understanding of global regulatory trends for CMC activities to ensure robust and high quality regulatory submissions in all active countries
  • Develop, implement and execute a smart procurement strategy
  • Lead key global CMC initiatives and represent Pharmaceutical Science to other key cross-functional stakeholder initiatives.
  • Manage the functional area's budget and human resources within required limits
  • Drive continuous improvement of the technology, methodology and business processes used to support analytical development, characterisation and associated operational and documentation systems
  • Sound knowledge of ICH and other regulatory guidelines, including Quality by Design.
  • Actively understand future trends in medicine to build an adaptable organisation for the future
  • Build trust with team members and lead the culture by fostering a healthy and inclusive work environment
  • Build future leadership skills by mentoring direct reports and junior staff members
Qualifications:
  • Master's or PhD degree in chemistry, biology, pharmacy or related pharmaceutical sciences; m At least 10 years of relevant industry experience, including extensive experience in analytical science, cGMP compliance and CMC regulatory requirements in multiple areas of analytical development.
  • Leadership experience of teams consisting of managers and scientists. Development of team members into managers of scientific analytical teams, including individual contributors with an exceptional commitment to science.
  • Direct experience in analytical development for biologics and ability to drive study completion in a timely, sustainable, robust and cost-effective manner
  • Drive decision making within a cross-functional and cross-cultural global team structure
  • Knowledge and experience of product development and clinical care processes and product commercialisation. High quality experience is an advantage
  • Experience in reviewing and approving analytical CMC sections of IND/IMPD and BLA/MAA regulatory submissions. Knowledge of European, Japanese, Chinese and US CMC regulatory requirements for biologics.
  • Develop, implement and execute a smart sourcing strategy.
  • Knowledge of analytical chemistry of biologics to support the development of drug substance and drug product release and stability, raw material control, process control and characterisation methodologies.
  • Exceptional problem solving and troubleshooting skills related to analytical methodology.
  • Demonstrated knowledge of current GMPs, ICH guidelines including Quality by Design, other regulatory requirements and various quality systems.
  • Demonstrated knowledge, skills and abilities in statistical analysis (with emphasis on analytical testing applications).
  • Knowledge of complex and state-of-the-art methodology for GMP method development and characterisation of biologics.
  • Proven ability to work efficiently and effectively as a leader of managers and scientists
  • OPEX and CAPEX budgeting and controlling skills, as well as efficient resource planning
  • Strong verbal, presentation and written communication skills. Able to articulate complex technical issues accurately and deliver effective presentations to non-technical audiences.
  • Ability to build collaborative and trusting relationships internally and with external partners.
  • Requires strong organisational skills and attention to detail in writing and proofreading materials, scheduling, setting priorities and meeting deadlines.
  • Other professional competencies include: Building authentic relationships, global and cross-border communication, excellence in delivery, courage to challenge, inspire and motivate others.
  • A willingness to travel of approx. 10-15% is required, including domestic and international flights with overnight stays

The basic salary consists of the remuneration according to the collective agreement (at least € 73.187,94/year on a full-time basis) and any market-adjusted overpayment. The actual salary will be determined on the basis of qualifications, professional experience as well as individual competences.

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Kontakt
Marco Bannier
13042
Pharma
10.05.2023
n. A.
Permanent
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