Manager/ Senior Manager, Biologics MSAT

Vacancies

Manager/ Senior Manager, Biologics MSAT

Job Introduction

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

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. Manager, MSAT (Manufacturing Science & Technology) is a subject matter expert who will play a key role in the progression of pipeline candidates by providing technical oversight of Drug Substance and support some of Drug Product efforts both internally and externally through a network of third-party providers including CDMOs.

The primary function of the Manager, MSAT is to assist the Director of CMC Biologics Operations in planning and overseeing manufacturing related activities through the product development life cycle of biologics pipeline programs primarily related to drug substance manufacturing. The person will be a key member in supporting manufacturing activities at the various sites within the external manufacturing network (CDMOs) including technology transfer, manufacturing readiness, and execution. The position will support ongoing deviation investigations, change controls, CAPAs, and assist in clinical phase manufacturing and validation activities at the sites. 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 in quality. The right candidate should have broad professional experience and the drive to work with both internal and external stakeholders to execute cGMP and USDA manufacturing of Drug Substance clinical supply. This position offers an opportunity to apply experience and skills in technology transfer and manufacturing of biopharmaceuticals.

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:

• Serves as MSAT SME providing support of technology transfer and manufacturing activities with CDMOs.
• Understands the technical and scientific aspects of biologics drug substance manufacturing science and technology. Understanding of Drug Product manufacturing is also desired.
• Contribute to establishment of best practices and technical ways of working within manufacturing and development teams.
• Maintain on-site presence when required, at the CDMO facility as Person-In-Plant (PiP) to ensure flawless execution of clinical and commercial batches.
• Effectively communicates with external partners to drive manufacturing readiness and execution to meet company objectives and on time delivery of clinical supply.
• Ensure operational readiness including facility fit, equipment, materials procurement, and documentation.
• Reviews and approves protocols, manufacturing batch records, and supporting documentation for regulatory submissions.
• Performs process monitoring to assess performance of the external manufacturing sites.
• Provides technical input into quality deviations related to the manufacturing process and supports product impact assessment, root cause investigations and potential corrective and preventive actions in close collaboration with the External Site.
• Uses technical writing skills to ensure change controls and deviation reports are clear, concise and complete.
• Ensures timely progression of change controls and deviations.
• Supports internal manufacturing capital projects.
• Supports execution of process characterization and process performance qualification batches at CDMOs.
• Supports continuous process verification (CPV) activities including process monitoring and preparation of required annual reports.
• Partners with other CMC functions, regulatory and quality leads to ensure a culture of quality with our CDMO's and to ensure that all activities and documentation comply with regulatory requirements.
• 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

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.
• Understanding of the science and technology underlying Biologics Drug Substance manufacturing. Knowledge of Drug Product manufacturing is a plus.• Demonstrated understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations will be essential.
• Working knowledge of new product introduction, technology transfer, process validation, and production support .
• Experience working in cGMP environment.
• Hands-on experience at laboratory, pilot, or manufacturing scale for biologics.
• Ability to travel (domestic/international) approximately 25-30%.

Desirable

• Strong experience in process scale-up, tech transfer, and validation.
• 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 development and manufacturing.
• Working knowledge of lean and/or six sigma operations.

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.