Head of Analytical Development & Technologies Drug Substance & Drug Product (m/w/d)

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Basel, Schweiz | 
Temporary Employment
Job title: 

Head of Analytical Development & Technologies Drug Substance & Drug Product (m/w/d)

Industry: Pharma
Skills: Analytical Development, CMC, Drug Substance
Start of project: 01.11.2023
Duration of the project : 12 months
Location: Basel, Switzerland

This position is responsible for strategic planning, delivery of innovated methodologies and execution of all analytical development activities supporting all preclinical programs.


The Head of Analytical Development & Technologies Drug Substance & Drug Product will lead early-stage analytical development, method verification and transfer activities necessary for API (Active Pharmaceutical Ingredient) release, as well as lead analytical troubleshooting exercises during technical transfers.


Tasks:

  • Responsibilities include, but are not limited to, the Following:
  • Directs the overall scientific, technical and laboratory efforts of the ADQC Drug Substance Pre-clinical group responsible for analytical development/verification of analytical methods for APIs
  • Lead a team of scientists to develop comprehensive analytical understanding of products in pre-clinical development
  • Apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development
  • Lead technical review of analytical data and methods/stability/protocols/reports generated by internal and external laboratories to support early stage clinical programs.
  • Authors method development, verification reports and test methods. Evaluates suitability of new methods and oversees method qualification and validation
  • Serves as a primary contact person for cross-departmental needs or projects and is accountable for key deliverables
  • Leads a high-performing team of analytical scientists who are cross-functionally aligned with Pharmaceutical Development & Commercial Supplies Teams strategies and priorities to ensure individual development candidates are advanced to meet global project requirements and corporate objectives.
  • Supports and develops the scientific and technical capabilities of the department and the development of scientific and management staff
  • Leverages scientific and cross-functional experience to drive collaboration, interpretation of data to inform decision-making and value
  • Works in collaboration with Process Research, Preformulation and Preclinical Galenics, Chemical Development and external manufacturing colleagues to implement analytical controls, and support manufacturing and testing at CMOs
  • Provides input to the development of project strategies, budgets, timelines, and product development plans.
  • Helps ensure that scientific and business expectations are met.
  • Collaborates with Development groups to define API physicochemical and quality attributes, testing methods, stability profiles and specifications
  • Provides committed and inspiring leadership, process knowledge development, continuous improvement, risk assessment and mitigation, resource allocation and support as appropriate.
  • Create an environment that attracts, develops, retains and promotes diverse scientific, technical and management talent
  • Direct management of personnel including performance appraisals, promotions, salary administration, staff hiring, mentoring, and other personnel related activities
  • Planning and management of ADQC Analytical Technologies and Preclinical Support operating and capital budgets for internal and external expenses, as well as planning of resources to accomplish objectives on an ongoing basis

Qualifications:
  • Analytical Chemist, Pharmaceutical Chemist or related scientific discipline
  • BS with 18 +, MS with 14+ or Ph.D with +8 years' experience in the pharmaceutical industry with increasing scientific and leadership responsibilities in analytical development
  • Broad knowledge and experience in the development and validation of test methods for small molecule drug substance candidates, physical and chemical characterizations, general analytical analysis, assay/impurity analysis, purity/related substances and PGIs
  • Skills building and maintaining productive relationships with organizational counterparts such as Toxicology, Reformulation and Preclinical Galenics, Chemical Development, Process Research, Quality Assurance and Regulatory CMC
  • Scientific knowledge, high level of innovation and experience in analytical science in drug development and associated analytical requirements throughout the development phases
  • Broad knowledge of the pharmaceutical development process
  • Knowledge of applicable global drug development and regulatory standards with strong analytical and strategic thinking
  • Knowledge and application of cGMPs/GLPs, ICH, FDA and CMC Guidance Documents.
  • Experience with CMC technical sections of regulatory submissions and addressing regulatory authorities on technical matters
  • Experience in technology transfer of test methods to manufacturing sites
  • Scientific and problem-solving capabilities and cross-functional understanding
  • Experience in budget planning and oversight
  • Excellent oral, written, presentation and communication skills
  • Experience managing technical professionals including PhD staff, with a track record of fostering staff development
  • Situational leadership skills (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation)
  • Fluent in English

Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Lars Uhl
13616
Pharma
01.11.2023
12 months
Temporary Employment
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