*Remote* - Drug Product, MSAT - Principal/ Associate Director

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

We are looking for a talented individual to join our dynamic Drug Product Development team within the Company’s Biologics CMC organization, where we drive the maintenance and evolution of both clinical and commercial products and programs.

We're passionate about pioneering advancements in current and future offerings.

Qualifications :

• A Bachelor's degree in a science or engineering field, preferably with a focus on manufacturing processes or chemical analysis of biologic pharmaceuticals.
• A minimum of 7 years (preferably 10 or more) in a GMP-regulated area of the pharmaceutical industry.
• At least 5 years (preferably 7 or more) of experience in manufacturing, development, and / or analytical testing of drug products.
• Experience with both vial and pre-filled syringe dosage forms.
• Regulatory experience

Skills :

• Strong understanding of GMPs, especially as they pertain to biologic drug product manufacturing.
• Capability to manage programs remotely at contract manufacturing sites and analytical or development laboratories.
• Familiarity with laboratory assay principles for testing biologic drug products.
• Competency in basic practices of drug product development, including establishing design spaces and phase-appropriate progression.
• Knowledge of drug product manufacturing processes for both vials and syringes, including sterilization methods.
• Understanding of validation principles for processes and equipment.
• Excellent writing skills, particularly in crafting protocols / reports and regulatory documents.
• Proven communication and presentation abilities.
• Capacity to work independently and manage multiple tasks and projects with minimal supervision.

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age.

We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI.

We strive to create a welcoming and inclusive environment for all employees.