Associate Director, Biologics CMC Quality

Summary

*This is a remote position open to candidates located in North America or Europe.*

Invetx, a division of Dechra, is a veterinary biotechnology company based in the USA, engaged in the discovery and development of novel therapeutic proteins for the treatment of important diseases in veterinary species, focused on companion animals, using a proprietary platform that combines industry-leading technologies. In July 2024, Dechra Pharmaceuticals acquired Invetx. Invetx continues its focus on bringing differentiated biotherapeutics for dogs and cats to the animal health market as its own division within the Dechra organization.

The Associate Director of Biologics Drug Product Operations will play a key role in progressing pipeline candidates by providing oversight of drug product manufacturing and supply chain efforts, both internally and externally, through a network of third-party providers, including CDMOs.

The primary function of the Associate Director of Biologics Drug Product Operations is to lead drug product manufacturing operations and execution for biologics pipeline programs. The person in this role will be a key member in leading and building the CMC systems and network necessary to support drug product material supply for pivotal phase clinical studies, process validation, and commercial product launch. Additionally, the role will interface with CMC Development, Operations, Clinical, Quality, Discovery, and external CDMO teams to maintain coherence in technical development, manufacturing, submission of regulatory content, and compliance with quality. The ideal candidate should have broad professional experience and the drive to work with both internal and external stakeholders to define and manage the execution of cGMP and USDA manufacturing of drug product supplies. This position offers an opportunity to apply experience and skills across drug product manufacturing, supply chain, and related project management.

Main Responsibilities

• Serve as the main point of contact for biologics drug product (DP) CDMOs, building and maintaining strategic relationships with 3PLs and CDMOs.
• Responsible for driving execution of DP production plans for FDA, EMA, USDA, and other animal health agency-regulated pipeline programs.
• Provide operational oversight and troubleshooting support to ensure all deliverables meet company requirements, including successful execution of DP manufacturing operations, on-time shipments, quality compliance, and cost management.
• Maintain on-site presence when required at the CDMO facility as Person-in-Plant (PiP) to ensure flawless execution of clinical and commercial DP batches.
• Support review of CMC technical development documents focused on DP process and execution of DP process performance qualification (PPQ) and commercial DP batches.
• Partner with other CMC leads to develop a long-term manufacturing network strategy and maintain a flexible, reliable, robust, and cost-effective manufacturing network.
• Manage DP change management records, outsourced DP labeling, packaging, distribution activities, CMOs, and other external suppliers.
• Lead continuous improvement initiatives to resolve DP supply issues and increase productivity.
• Partner with other CMC functions, regulatory, and quality leads to ensure a culture of quality with our CDMOs and ensure that all activities and documentation comply with regulatory requirements.
• Establish a robust tracking and reporting process to monitor CDMO performance using a set of standard objectives and report progress to management.
• Lead identification and resolution of business-critical and contract issues; lead escalations to CMC technical and quality leadership.
• Work closely with Discovery and Clinical teams to ensure timely supply of DP material for clinical studies.
• Assist with CMC development alliance management and product development strategy. Serve as a liaison and streamline current interactions with external partners for biologics DP.
• May lead, manage, and participate in internal manufacturing of drug product batches, warehouse, and capacity capital projects.
• Coordinate with legal, technical, and development teams to establish nondisclosure agreements, service terms and conditions, and quality agreements. Review and facilitate approval of proposals, work orders, and changes.
• Represent Dechra in a highly professional manner with integrity, respect, determination, and ethics. Foster a team culture of collaboration, communication, ownership, and accountability.

Ideal Candidate

• An understanding of the science and technology underlying biologics drug product manufacturing, including primary and secondary packaging, labeling, transport, and distribution.
• Bachelor's, Master's, or PhD in Life Sciences, Pharmaceutical Sciences, Bioprocess or Chemical Engineering, or a related field.
• Ideally, 9+ years of experience in the biotech/pharmaceutical industry.
• Demonstrated understanding of the technical aspects of manufacturing, testing, and controls, and the regulations governing pharmaceutical operations.
• Good working knowledge of biopharmaceutical drug product process development, manufacturing, and analytical development/quality control.
• Experience in negotiating and executing process and product development activities.
• Experience with negotiating DP manufacturing contracts and master service agreements.
• Ability to travel (domestic/international) approximately 25-30%.

Desirable:

• Knowledge of the animal health industry regulatory guidelines for CMC under FDA, EMA, USDA, and other regulatory agencies.
• Working knowledge and understanding of current regulations and industry trends for large molecule DP product development and manufacturing.
• Working knowledge of lean and/or six sigma operations.
• Passionate about animal health and getting innovative veterinary medicines to market.

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