Head of Analytical Development & Technologies Drug

• Salary: 103.38 – CHF 111.86 all-in
• REF Number: 00056502
• Consultant: Adrien Guimard
• Contact: 0041 (0) 800 106 106
• Date Published: 18.01.2024
• Sector:
• Location: Basel,
• Discipline:

QLS are recruiting for a Head of Analytical development to join an innovative Pharmaceutical company on a contract basis for one year.

Responsibilities Include, But Are Not Limited To The Following

• Leads the ADQC Analytics department consisting of 3 subteams :
• Analytical projects, Lab Organization and Medical Device & Combination Products
• By giving direction in overall scientific, technical and laboratory efforts of the department responsible for analytical development/validation of analytical methods for small molecule, release and stability testing and method transfers to manufacturing sites.
• Leads high-performing teams of analytical scientists who are cross-functionally aligned with Technical Operations strategiesand priorities
• Identifies analytical science capabilities and technology tools needed to enable pharmaceutical manufacturing process development and understanding of development candidates and their quality and performance attributes.
• Ensures the ADQC Analytics teams work as a productive development partner with collaborators and teams
• Leverages scientific and cross-functional experience to drive collaboration, interpretation of data to inform decision-making and value to Company
• Works in collaboration with Process Chemistry, Chemical Development Pharmaceutical Development and external manufacturing colleagues to implement analytical controls, and support manufacturing and testing at CMOs and for the CMUs..
• Develops, ensures the delivery of high quality-related documentation to meet global regulatory expectations for analytical methods and controls. Delivers analytical source documentation for CMC sections of IND/NDA filings for Company’s NCEs.
• Provides input tothe development of project strategies, budgets, timelines, and product development plans.
• Collaborates with Development groups to define API (Active Pharmaceutical Ingredient)& DP physico-chemical and quality attributes, testing methods, stability profiles and specifications.
• Create an environment that attracts, develops, retains and promotes diverse scientific, technical and management talents.
• Direct management of personnel including performance appraisals, promotions, salary administration, staff hiring, mentoring, and other personnel related activities.
• Planning and management together with the Head of ADQC the operating and capital budgets for internal and external expenses

Candidate`s Requirements:

• Analytical Chemist, Pharmaceutical Chemist or related scientific discipline. BS with 12 +, MS with 10+ 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 and large molecules, physical and chemical characterizations, general analytical analysis, assay/impurity analysis, purity/related substances, PGIs, cleaning verification/validation, content uniformity, dissolution and testing of medical devices.
• Skills building and maintaining productive relationships with organizational counterparts such as Toxicology, Chemical Development, Process Chemistry, Preformulation and Pregalenic Development, Drug Product Development, Clinical Manufacturing Units, Quality Assurance.
• Scientific knowledge and experience in analytical science in drug development and associated analytical requirements throughout the development and commercial phases.
• Knowledge and application of cGMPs/GLPs, ICH, FDA and CMC Guidance Documents. Experience with CMC technical sections of regulatory
• Broad knowledge of the pharmaceutical development and commercialization process covering Drug Substance and Drug Product including Medical Devices.

Apply

For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email [email protected]. Please could you send any correspondencein English. Please quote job reference 56502 in all correspondence.