Associate Director, Analytical Development & Quality Control

 Overview:

We are seeking a highly experienced Associate Director: Analytical Development and Quality control to join the Analytical Development and Quality Control group to support analytical development and QC operations for all the products in clinical development and commercialization stage. This newly created position will report to the Senior Director of Technical Development and will coordinate analytical development, validation, and testing operations both internally and at external CDMO/CRO partners and author relevant sections of regulatory filings.

Summary of Key Responsibilities:

·      Chemical and physical characterization of drug substance and drug product attributes, identification of technical risks, and collaboration on risk mitigation strategy.

·      Method development for and analytical characterization of drug substances, drug products, and product stability.

·      Management of method development, method validation, QC testing, and reference standard management activities internally and at CDMOs/CTLs.

·      Management of forced degradation, long term stability, and predictive stability studies.

·      Contribution to OOS/OOT investigations.

·      Critical review of data, protocols, reports, specifications, and other documentation.

·      Trending stability data and establishing retest periods/shelf life using statistical methods.

·      Collaboration in the development of material control strategies and specifications.

·      Authorship of technical documents including test procedures, analytical development reports, product specifications, validation and stability protocols, COAs, stability reports, and storage statements.

·      Authorship of relevant NDA/MAA sections.

·      Collaboration toward responses to health authority requests for information.

·      Collaboration in multidisciplinary teams that include Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPK.

·      Management and organization of documentation and data.

·      Ensuring compliance to cGMP quality standards and internal SOPs.

·      Travel up to 15%.

Qualifications:

·      Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)

·      BS/MS degree with 10 years or PhD with 6 years of experience in pharmaceutical development.

·      Expertise in HPLC method development is essential.

·      Additional experience in techniques such as gas chromatography, NMR, mass spectrometry, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIR is needed.

·      Experience in analytical development and validation for drug substances, starting materials, synthetic intermediates, and sterile drug products.

·      Experience in management of analytical activities at CDMOs/CROs.

·      Experience managing stability programs, reference standards, and retest/expiry.

·      Familiarity with ICH guidelines, 21 CFR, and pharmacopeial chapters.

·      Experience in OOT/OOS management, deviation management, and change control.

·      Ability to ensure assigned activities are completed in satisfaction of project timelines.

·      Strong interpersonal skills that foster collaboration within and outside of the organization.

·      Ability to travel domestically and internationally. 

Aviceda Therapeutics is an equal opportunity employer offering competitive cash and stock compensation, excellent employee benefits, and the opportunity for personal and professional growth in an outstanding and intellectually challenging environment.