Senior Manager - Biologics Drug Product Operations

Senior Manager - Biologics Drug Product Operations

Job Introduction

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra!

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 3000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.

The Opportunity

The Senior Manager, Biologics Drug Product Operations is a key technical leader responsible for advancing the biologics pipeline through oversight of drug product development, manufacturing and supply activities. The position is accountable for managing Contract Development and Manufacturing Organizations (CDMOs), supporting technology transfer, process characterization, process validation, Process Performance Qualification (PPQ) and support Manufacturing and supply group with commercial launch readiness activities.

The Senior Manager works closely with cross-functional stakeholders to drive manufacturing excellence, regulatory compliance, quality performance and supply continuity across biologics programs.

Reporting to the Director, Biologics Drug Product Operations, this individual will play a critical role in overseeing late-stage development and GMP manufacturing activities supporting pivotal clinical studies, PPQ campaigns, and commercial supply. The role includes serving as Person-in-Plant (PiP) during critical manufacturing operations, providing onsite technical leadership, issue resolution and oversight of manufacturing readiness, batch record review, investigations and validation activities.

This role offers a unique opportunity to influence the successful development, validation and commercialization of innovative veterinary biologics while partnering with world-class CDMOs and cross-functional teams to bring transformative therapies to market. The successful candidate will possess deep expertise in biologics drug product development and manufacturing, extensive experience managing external manufacturing partners and demonstrated success leading complex cross-functional initiatives that support regulatory submissions.

Role Responsibility

So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:

• Serve as the primary operational lead for external drug product CDMOs and manufacturing partners, establishing strong relationships to ensure successful execution of clinical, PPQ, and commercial GMP manufacturing programs.
• Manage clinical stage CDMO performance, contractual deliverables, manufacturing schedules, budgets, and risk mitigation plans to support development and commercial objectives.
• Act as Person-in-Plant (PiP) during critical manufacturing, process validation and PPQ campaigns, providing onsite leadership and rapid issue resolution.
• Provide technical oversight for early to late clinical stage biologics drug product development, manufacturing operations, process validation and commercial readiness activities.
• Lead and support technology transfer, process characterization, validation strategy development, and PPQ readiness programs.
• Identify manufacturing and process risks and implement appropriate mitigation strategies to ensure successful execution and regulatory compliance.
• Coordinate PPQ planning and execution activities, including manufacturing readiness assessments, campaign oversight, data review and validation report preparation.
• Review and approve manufacturing and validation documentation, including protocols, technical reports, manufacturing proposals, batch records, deviations, investigations, CAPAs and change controls.
• Ensure all manufacturing activities are conducted in compliance with cGMP requirements and applicable regulatory expectations.
• Support preparation and review of CMC documentation for regulatory submissions, inspections, agency interactions and responses to health authorities.
• Collaborate closely with CMC Development, CMC Operations, Manufacturing and Supply, Quality, Regulatory Affairs, Clinical Operations and external partners to achieve program milestones and business objectives.
• Drive alignment across stakeholders to ensure timely execution of manufacturing campaigns, regulatory commitments and supply plans.
• Support establishment and maintenance of quality agreements, master service agreements, statements of work and other strategic partnerships with external providers.
• Champion continuous improvement initiatives that enhance operational performance, product quality, supply reliability, compliance and CDMO effectiveness.
• Promote a culture of accountability, collaboration, innovation and operational excellence across internal and external teams.
• Represent Dechra professionally and ethically, demonstrating integrity, respect, determination and commitment to company values in all interactions.

The Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are:

• Bachelor, Master, or PhD in Life Sciences, Pharmaceutical Sciences, Bioprocess or Chemical Engineering, or related science.
• Extensive experience of biotechnology or pharmaceutical industry experience with significant experience in biologics drug product development and manufacturing.
• Understanding of biologics drug product manufacturing, aseptic processing, fill-finish operations, packaging, labelling, storage and distribution.
• Demonstrated experience supporting late-stage clinical and commercial manufacturing programs.
• Experience managing external CDMOs for GMP drug product manufacturing.
• Experience serving as Person-in-Plant (PiP) during GMP manufacturing campaigns.
• Experience reviewing and approving CMC technical development documents
• Understanding of process validation principles and lifecycle management.
• Working knowledge of PPQ planning, readiness activities, execution, and reporting.
• Ability to travel (domestic/international) approximately 25-40%.

Desirable

• Passionate about animal-health and getting innovative veterinary medicines to market.
• Thrives in a fast-paced, highly collaborative biotechnology environment
• Knowledge of the animal health industry regulatory guidelines for CMC under FDA, EMA and USDA and other regulatory agencies.
• Working knowledge and understanding of current regulations and industry trends for large molecule DP product development and manufacturing.
• Experience supporting commercial product launches.
• Knowledge of sterile manufacturing operations and Annex 1 requirements.
• Working knowledge of lean and/or six sigma operations.