Associate Director, Biologics CMC Quality

Job Introduction

*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 CMC quality will play a key role in the progression of Biologics pipeline candidates by providing quality assurance oversight of key CMC development and manufacturing efforts that are currently ongoing both internally and externally through a network of third-party providers including CDMOs and CROs.

The primary function of the Associate Director of Biologics CMC Quality is leading Biologics CMC Quality assurance necessary to support the growth of the company toward pivotal phase clinical studies and commercial product launch.  The person will be a key member in leading and building the CMC quality system and ensuring quality assurance.  Additionally, the role will interface with CMC Development, Operations, Regulatory, Clinical and external CDMO teams . The right candidate should have relevant experience in managing quality systems to manage the execution and proper disposition of Drug Substance and Drug Product batches according to cGMP (21CFR) and USDA (9CFR) regulations.  

Main Responsibilities

• Serve as member of CMC team for providing Quality Assurance (QA) input from pre-clinical to late-stage commercial launch of pipeline programs and to support NADA, MAA and other regulatory filings. 
• Partners with technical SMEs to develop and approve the overall CMC strategy for progressing pipeline programs especially through clinical and commercial manufacturing stages. 
• Assessment of quality system for CMC currently in place within Biologics unit and at CMDOs/CROs to determine needs for GMP compliance for late-stage programs and commercialization of pipeline molecules.
• Support authoring of policies, SoPs and procedures to ensure compliance.
• Responsible for representing the CMC group for introducing best practices to the quality management systems (QMS)
• Review and approve GMP documentation for Biologics DS and DP manufacturing of batches.
• Support review of specifications and CoAs for batch disposition, and stability related documentation
• Support evaluation and further development of QMS for supporting  CMC in alignment broader QMS needs and in collaboration with other consultants and other employees.
• Evaluate and support use of appropriate quality data management software (QDMS) .
• Support qualification of new vendors and audits of existing vendors/CDMOs.
• Provide quality assurance support when needed and provide vendor management support as directed by the management team.
• Support review and approval of late-stage analytical method and process validation related protocols and documents
• Responsible for change control management through the product lifecycle to include impact assessments, tracking, and implementation.
• Also, as appropriate, responsible Quality member for oversight of all key Quality System deliverables associated with the drug development candidate including proactive Initiatives, Deviations, Investigations, CAPAs, and Complaints. 
• Work with CMC Teams to conduct risk assessments, as required, for all aspects of the drug development process.
• Responsible for communicating Quality risks within the Quality organization. 
• Collaborate with Regulatory to own Quality input for ongoing regulatory filings and updates to regulatory agencies including specifications, shelf-life extensions, etc.
• Collaborate with other CMC members and cross-functional groups to ensure successful execution of various CMC projects, and delivery of results on time and quality.
• Represent Dechra in a consistent highly professional manner with integrity, respect, determination and in an ethical manner. Foster a team culture of collaboration, communication, ownership, and accountability.

The Ideal Candidate

• Bachelor, Master, or PhD in Life Sciences, Pharmaceutical Sciences, Bioprocess or Chemical Engineering, or related science.
• Ideal candidate will have 9+ years of experience in the biotechnology industry with significant experience in quality assurance for GMP manufacturing of biologics, especially monoclonal antibody (mAb)-based products, and experience with global contract manufacturing networks and 3rd party relationships.
• Good working knowledge of biopharmaceutical process development, including biologics (mAb) Drug Substance and Drug Product process and quality control.
• Proven ability to navigate complex CMC quality aspects and requirements effectively.
• Working knowledge and understanding of current regulations related to cGMP and GLP practices, and industry trends.
• Ability to travel (domestic/international) approximately 20-25%.

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.
• Passionate about animal health and getting innovative veterinary medicines to market.

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About The Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.