Job Description
This is a unique opportunity to be part of a dynamic clinical-stage biotechnology company focused on discovering and developing novel therapies that have the potential to revolutionize the treatment of progressive diseases.
The company has experienced rapid growth in 2023, and this role offers the chance to contribute to its success as a Drug Substance Manager. This permanent position involves working in a hybrid setup based in Dublin HQ.
Key Responsibilities
* Drive drug substance commercial process development through provision of synthetic and manufacturing technology expertise.
* Ensure timely and coordinated supply of drug substance requirements.
* Collaborate with the Analytical Services Manager to design, develop, validate, and transfer suitable analytical methods and specifications related to APIs, raw materials, and intermediates.
* Manage relationships with contractors and suppliers, including selection, contracting, management, timelines, and cost control.
* Oversee drug substance manufacturing site qualification and validation.
* Manage new product introductions and technical transfers.
* Interface with Quality to review vendor batch records, deviation reports, risk assessments, and CAPAs; ensure drug substance batches comply with specifications and processes.
* Manage and follow up with CMOs on a regular basis to ensure projects progress as expected.
* Author and contribute to drug substance sections of INDs, IMPDs, and other regulatory submissions.
* Interface with other functions as required.
Requirements
* Ph.D. or Master's degree in a relevant scientific discipline or business management.
* Minimum 5-8 years of experience in drug-substance development or manufacturing.
* Self-motivated with the ability to work in a fast-paced environment.
* Attention to detail and team player.
* Experience with GMP/ICH regulations and guidelines.
* Strong organizational, communication, and decision-making skills.
* Ability to interact effectively with all levels of internal and external management.