Manager / Sr. Manager - Biologics CMC Operations

Vacancies

Manager / Sr. Manager - Biologics CMC 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

Invetx Inc., a Division of Dechra, is a veterinary biotechnology company based in the USA that is engaged in the discovery and development of novel therapeutic proteins for the treatment of important diseases in the 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 to bring differentiated biotherapeutics for dogs and cats to the Animal Health market as its own Division within the Dechra organization.

The Manager / Sr. Manger, Biologics CMC Operations will play a key role in the progression of biologics pipeline candidates and will be responsible for leading contract development, drug substance (DS) manufacturing operations activities and building related network of CDMOs/CROs. Working in collaboration with Invetx team members and our external partners in the planning and oversight of development and DS manufacturing activities is a key aspect of the role. This position offers an opportunity to apply your experience and skills across all aspects of clinical and commercial DS manufacturing from planning of manufacturing activities, project management, clinical and commercial supply of our products in North America, Europe and other markets. The person will be a key member of the CMC team of the company and will help build the CMC systems and network for manufacturing operations necessary to support the growth of the company toward pivotal phase clinical studies and commercial product launch.

Main Responsabilties

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

• Support implementation of comprehensive CMC strategies from IND-enabling activities through clinical-stage development, clinical supply, and commercial manufacturing and supply for FDA, EMA and USDA-regulated products.
• Provide project management and guide the systematic progression of projects from the proposal stage through project completion by managing Contract Development and Manufacturing Organizations (CDMOs) and other third-party vendors related to CMC activities ensuring high-quality execution and adherence to timelines and budget.
• Ensure all CMC activities comply with global Good Manufacturing Practice (GMP) and relevant regulatory guidelines.
• Oversee drug substance process development, manufacturing, and scale-up activities at CDMOs.
• Oversee successful technology transfers at CDMOs and between different manufacturing sites.
• Ensure on-time delivery of clinical supply.
• Serve as primary CMC lead on cross-functional project teams to ensure successful execution of pipeline projects, and delivery of results in-line with company goals and timelines.
• May support internal manufacturing and capital expense projects.
• Support negotiation of contracts and agreements related to process development and manufacturing for the Invetx product portfolio.
• Work in collaboration with the CMC team to review and facilitate approval of proposals, work orders, and change orders.
• Participate in site visits and support quality audits and quality agreements as required.
• Represent Dechra in a consistent highly professional manner with integrity, respect, determination and in an ethical manner. Fosters a team culture of collaboration, communication, ownership and accountability.

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. Ideal candidate will have extensive experience in biotech/pharmaceutical industry.
• Understanding of the science and technology underlying Biologics Drug Substance manufacturing platforms including fed-batch/continuous manufacturing and technology transfer.
• Demonstrated understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations will be essential.
• In-depth knowledge of biopharmaceutical drug development, including upstream and downstream processing and purification.
• Comprehensive understanding of global GMP regulations (FDA, EMA, ICH) for biologics.
• Commitment to quality and scientific rigor.
• Strong project management skills, managing and delivering on multiple priorities in parallel.
• Working experience in negotiating and executing process development activities.
• Exceptional communication and interpersonal skills, with the ability to influence and collaborate effectively.
• Familiarity with negotiating DS manufacturing contracts and master service agreements.
• Ability to travel (domestic/international) approximately 25-30%.
• The candidate should be comfortable working in a virtual project team environment

As 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.