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Head of Analytical Developement, Europe (gn)
Wien, Österreich |
Permanent
Job title: Head of Analytical Developement, Europe
Duration of employment: Unlimited
Industry: PharmaSkills: 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.
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Marco Bannier
13042
Pharma
10.05.2023
n. A.
Permanent
