Associate Director/ of Analytical Development

EU

About the position:

Reporting to the Head of CMC, the CMC Associate Director/Director of Analytical Development* will be responsible for providing strategic leadership and tactical support for all analytical activities for small molecule drug substance and oral solid dose drug product including support for global regulatory applications for authorization of clinical trials in all phases of drug development. You will work closely with contract manufacturing organizations (CMOs) and will be responsible to ensure that all applicable policies and procedures, including International Conference on Harmonization (ICH) requirements are met. In addition, you will identify, escalate, and solve any obstacles ensuring the NDA/MAA chapters related to analytical controls are on track.
As a successful analytical chemist at Prilenia, you’ll bring your breadth of experience, ranging from management and oversight of CMOs at a late-stage clinical development, Analytical chemist skills to ensure all DS and DP analytical activities run smoothly and the documentation is accurate and comply with regulatory guidelines. You will also actively contribute to the preparation for registration of pridopidine for marketing approval.

Qualifications & Experience:

  •  MS or PhD in Analytical Chemistry, Chemistry, or equivalent scientific discipline.

  • 7 to 10+ years experience in analytical methods development supporting small molecule and solid oral dosage development programs.

  •  Must have 3- 5 years experience managing an analytical group and leading the analytical function in a company.

  • Experienced with managing work for projects at advance development stage at Contract Manufacturing Organizations and/or Contract Testing Labs.

  • In-depth experience with the development troubleshooting and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), identification of impurities and degradation products, reference standard qualification.

  • Ability to develop comprehensive analytical understanding of products in pre-clinical and clinical development.

  • Thorough knowledge of ICH Q1, Q2, Q3, Q6 and Q7 guidelines as applicable to drug substance and drug product quality aspects.

  • Experience preparing and updating regulatory filings (IND, IMPD, NDA, MAA).

  • Ability to function efficiently and independently in a changing environment.

  • Self-motivated, detail-oriented, excellent interpersonal and writing skills.

Main roles and Responsibilities:

  • Oversee all analytical activities conducted at third party labs including structure elucidation, method development and validation, stability studies, method transfer, testing of clinical materials and reference standards.

  • Oversee and manage relationships with CDMOs counterparts in compliance with quality standards (SOPs, GMP etc.) including delivering feedback and holding others to timelines and deliverables while maintaining strong professional relationships

  • Manage stability studies to support clinical and non-clinical candidates including data trending

  • Coordination of tasks towards assembling of required information and contribution to respective documents (e.g. risk analysis, briefing books, IND, IMPD, study plans and reports) in close collaboration with other relevant stakeholders

  • Responsible for ensuring that DS/DP analytical activities comply with overall development program and supports future NDA/MAA submission

Travel expectation:

  • Requires travel mostly to DS/DP manufacturing sites in Europe and US when circumstances allow. Frequent calls with Israel, EU and North America.

If you wish to apply for this position, please email your CV to