Drug Substance Manager / Senior Manager

This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.

Our client is focused on the discovery and development of novel therapies, with the potential to fundamentally change the course of progressive, debilitating diseases. 2023 has been a year of highly successful rapid growth in the company.

The preferred candidate will bring passion, energy and enthusiasm. An entrepreneurial business-oriented mindset and a strong fit with company ethos are essential traits. The role of Drug Substance Manager will be filled on a permanent basis. The role is hybrid, based in Dublin HQ.

Job Spec

The Drug Substance Manager is responsible for drug substance process development and manufacturing. This includes activities covering supply of drug substance for use in clinical studies, drug product development and the process and analytical development/validation activities necessary for successful registration and commercial manufacturing of drug substance. This individual will accomplish development and productions goals through the direction and management of work at Contract Organization’s (CO’s).

· Provide synthetic and manufacturing technology expertise and drive drug substance commercial process development.

· Ensure prompt and coordinated supply of drug substance requirements.

· Working with the Analytical Services Manager in the CMC team, oversee the design, development, validation, and transfer of suitable analytical methods and specifications related to APIs, their raw materials and intermediates for development and commercial manufacturing.

· Contribute to activities related to drug substance contractors and suppliers e.g., selection, contracting, management, timelines and cost control.

· Design and 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 CAPA’s; and ensure drug substance batches comply with specifications and processes.

· Interface with Quality to ensure vendors comply with GMP and Quality Agreements; manage process and/or documentation changes in accordance with GMP regulations.

· Manage and follow up with CMOs on a regular basis to ensure projects progress as expected. Ensure face to face contact with CMOs as necessary during the critical phases. Act as a “person in the plant” during key stages of critical manufacturing campaigns (e.g. process validation)

· Author and contribute to drug substance sections of INDs, IMPDs and other regulatory submissions.

· Interface with other functions as required, e.g., Regulatory, Medical Affairs, Quality, Clinical Supply, Finance, Commercial, Legal.

Person Spec

· Ph.D. or Master’s degree in a relevant scientific discipline or business management is desired

· Minimum 5-8 years of experience developing or manufacturing drug-substance.

· Self-motivated with the ability to work in a fast-paced unstructured environment.

· Attention to detail and team player.

· Experience with GMP/ICH regulations and guidelines.

· Possesses a thorough understanding of ICH guidelines.

· Strong organizational, communication, and decision-making skills.

· Ability to effectively interact with all levels of internal and external management, including international CMOs.

· Expert in quality impact assessments and conducting troubleshooting. Proven ability to conduct quality incident investigations (OOS, OOT, Deviations and Investigations).

· Experience with new product introductions and technical transfers.

· Experience preparing or supporting FDA/EMA submissions.

· Ability to work well in small teams and with other cultures.

Gerry Kennedy, Managing Director, Recruitment for Technology Ltd. Cv to gerry@rftgroup.ie /00 353 (0) 1 2302400