Director of Manufacturing Operations

Fraser Dove International; Scotland; On-site; GBP 120,000 - 190,000; Full time

Job summary

Fraser Dove International is recruiting an experienced leader to direct technology transfer for conjugation processes entering commercial manufacturing in the UK. The role requires directing technology transfer activities across R&D, quality, regulatory and manufacturing to ensure robust, compliant processes.

You will drive scale-up, characterisation and validation studies while maintaining cGMP standards and resolving complex manufacturing issues.

Qualifications

• 10+ years of experience in biologics manufacturing or MSAT with leadership exposure.
• Proven experience transferring, scaling up and validating conjugation processes.
• Strong knowledge of aseptic techniques and regulatory requirements for biologics.

Responsibilities

• Direct technology transfer activities for conjugation manufacturing processes.
• Establish and maintain technology transfer frameworks and governance.
• Coordinate transfer activities across R&D, quality, regulatory and manufacturing.
• Review and approve transfer protocols, reports and risk assessments.
• Guide process scale-up, characterisation and validation studies.
• Ensure compliance with cGMP and global regulatory standards.

Skills

Leadership

Project management

Cross-functional collaboration

Chromatography (ÄKTA)

TFF systems

Aseptic techniques

cGMP knowledge

Regulatory understanding

Education

PhD in Biotechnology/ Biochemistry/ Pharmacy/ Chemical Engineering

Master's or Bachelor's in Biotechnology/ Biochemistry/ Pharmacy/ Chemical Engineering

Tools

ÄKTA chromatography systems

Tangential Flow Filtration (TFF) systems

Job description

Head of Manufacturing Sciences and Technology Tech Transfer

Do you have the technical depth to direct technology transfer for complex conjugation manufacturing processes?

Can you guide process scale-up, characterisation and validation while maintaining current Good Manufacturing Practice (cGMP) standards?

Are you ready to bring cross-functional teams together to transfer biologic processes into commercial manufacturing?

Fraser Dove International is partnering exclusively with a specialist biopharmaceutical manufacturing organisation. Operating in the UK, they are committed to safe, compliant manufacture of biologic medicines.

Our client is seeking an experienced leader to direct technology transfer for conjugation processes entering commercial manufacturing.

Discover more about our Head of Manufacturing Sciences and Technology Tech Transfer, Conjugation Facility opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

• Transfer conjugation processes into commercial manufacturing with clear governance, approved documentation and controlled technical risk.
• Establish scalable, validated processes through characterisation, process data and statistical analysis, supporting reliable manufacturing performance.
• Maintain compliant manufacturing readiness by resolving complex process issues and applying aseptic and biologics regulatory requirements throughout the product lifecycle.

What you will do:

As the Head of Manufacturing Sciences and Technology Tech Transfer, Conjugation Facility, your duties and responsibilities will include:

• Direct technology transfer activities for conjugation manufacturing processes.
• Establish and maintain technology transfer frameworks and governance.
• Coordinate technical transfer activities across research and development, quality, regulatory and manufacturing functions.
• Review and approve technology transfer protocols, reports and risk assessments.
• Guide process scale-up, characterisation and validation studies.
• Ensure technology transfer activities meet current Good Manufacturing Practice and global regulatory standards.
• Provide technical direction for investigations into deviations and complex manufacturing process issues.

What you will bring:

These are the skills and experience you will need to succeed as the Head of Manufacturing Sciences and Technology Tech Transfer, Conjugation Facility:

• 10+ years of experience in biologics manufacturing, technology transfer or Manufacturing Sciences and Technology (MSAT), including at least three years in a leadership role.
• Proven experience transferring, scaling up and validating conjugation manufacturing processes.
• Proven expertise with chromatography systems, including ÄKTA, and Tangential Flow Filtration (TFF).
• Strong knowledge of aseptic techniques, current Good Manufacturing Practice and biologics regulatory requirements.
• Strong leadership, communication and project management skills, with experience working across technical and quality functions.
• PhD, Master's or Bachelor's degree in Biotechnology, Biochemistry, Pharmacy, Chemical Engineering or a related field.
• Experience with sterile dosage forms, including injectables or lyophilised products, is preferred.

Got what it takes?