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Head of Analytical Developement, Europe (gn) (DE)
[13042]
Analytical Development, Quality Control, ICH-GCP
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.
- 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.
- 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
- 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.
Marco Bannier