Associate Director, CMC Lead - Biologics (12 Month Fixed Term Contract)

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Job Reference ukpharmaron/TP/78/729

Number of Positions:

1

Contract Type:

Fixed-Term Contract

Competitive

Working Hours:

38

Location:

Liverpool

Region / Division:

Biologics R&D Organisation

Division:

Biologics R&D Organisation

Job Introduction

Location: Liverpool

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules to biologics and gene therapies, and we work with more than 3,000 global customers. To learn more, visit .

About the Role

We have a new opening for a Associate Director, CMC Lead on a 12 Month Fixed Term Contractto lead the CMC strategy for client programs, ensuring alignment with regulatory expectations and successful progression through development and licensure.

This successful candidate will act as a technical and strategic bridge between customers and functional teams (Process Sciences, Analytical Sciences, Manufacturing) and ensure effective strategy for delivery of client programs both internally and externally also be expected to deliver high-quality consultancy and submission support to both customers and internal teams.

At Pharmaron we offer:

• Vibrant and dynamic employment -we are a highly specialised, growth company operating in a critical sector of the economy - our future is strong and exciting!
• Opportunities to develop your skills and yourself -our rapid growth brings greater opportunities for you to learn and grow faster!
• A great team where we all support each other -enjoy your work - after all you spend about a third of your time here!

Key roles and responsibilities:

• Lead CMC strategy for assigned client programs across development stages (early development through to commercialisation).
• Responsible for ensuring alignment of development, manufacturing and control strategies with current global regulatory expectations (MHRA, EMA, FDA).
• Lead preparation and / or review of CMC regulatory submission dossiers for the customer and review, manage and interpret regulatory guidance and translate into practical development and control strategies
• Act as CMC sponsor on client projects, lead and support the project team to ensure robust and phase-appropriate control strategies are in place and risks to regulatory submissions are flagged and managed.
• Oversee validation activities for manufacturing processes, analytical methods, and cleaning procedures to align with customer needs, regulatory guidance and internal procedures.
• Provide consultancy services to customers and support project delivery by overseeing the technical design and reporting of CMC technical studies including process and analytical tech transfer, product comparability, process characterisation, and process validation
• Responsible for identifying regulatory trends and implementing changes within the organisation and internal procedures.
• Creates strategy for external partnering and collaboration as appropriate for internal/client requirements and oversees delivery.

Requirements:

• PhD or MSc in Life Sciences discipline or equivalent industrial experience
• 10+ Years experience including significant experience leading process and analytical transfer activities for development and GMP projects within the biotechnology industry as well as extensive CMC leadership across multiple / highly complex biologics programs
• Experience supporting process validation, analytical validation, and GMP manufacturing and risk management approaches
• Strong knowledge of global CMC regulations
• Clear understanding of science and a passion for keeping abreast of regulatory and industry changes across multi-modalities.
• Experienced in the manufacturing and testing of multi-modality biologics.
• Knowledge of GMP and Quality Management Systems.

Why Pharmaron?

Collaborative Culture: Thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

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