Manager/Senior Manager, Biologics CMC Project Management

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, with a focus on companion animals. Invetx uses a proprietary platform that combines industry-leading technologies. In July 2024, Dechra Pharmaceuticals acquired Invetx. Invetx continues to focus on bringing differentiated biotherapeutics for dogs and cats to the animal health market as its own division within the Dechra organization.

The Manager/Senior Manager of Biologics CMC Project Management will play a key role in progressing pipeline candidates by providing CMC project management of activities, both internally and externally, through a network of third-party providers, including CDMOs and CROs. Additionally, the role will interface with CMC Development, Operations, Clinical, Quality, Discovery, and external CDMO/CRO teams to ensure coherence in CMC activities related to technical development, manufacturing, submission of regulatory content, and compliance with quality standards. The ideal candidate for this role should have a biologics manufacturing project management background, be highly organized, and excel at developing strong relationships and networks. This position offers an opportunity to apply experience and project management skills across all CMC stages of animal health therapeutic development, from discovery to commercial product launch.

Main Responsibilities

• Work with the CMC Development and Operations teams to ensure that CDMOs and CROs fulfill proposal/contract requirements and complete process development or manufacturing projects as appropriate.
• Track the progress of projects.
• Coordinate and communicate project activities and information flow both internally within Dechra and externally with CDMOs and CROs.
• Manage scope changes during project execution.
• Coordinate regular internal project meetings to discuss and plan projects.
• Participate in regular meetings with contract organizations to update progress via teleconference or site visits as appropriate.
• Maintain accurate records to document all relevant communications related to projects.
• Support the maintenance of high-quality templates and communication formats and overall harmonization and organization of documentation within the function.
• Monitor timelines and contracts for accuracy and follow up on any discrepancies with third-party networks and/or internal personnel.
• Support CMC activities by tracking and maintaining development and manufacturing documentation.
• Manage the transfer of data and records from contract manufacturing organizations.
• Coordinate with legal, technical, and development teams to establish nondisclosure agreements, service terms and conditions, and quality agreements.
• Review and facilitate the approval of proposals, work orders, and changes in a timely manner.
• Represent Dechra consistently in a highly professional manner, with integrity, respect, determination, and ethics. Foster a team culture of collaboration, communication, ownership, and accountability.

Ideal Candidate

• Understanding of project management principles for coordinating biologics development and operations activities for drug substance, drug product, and analytical method development and validation is essential.
• Good working knowledge of biopharmaceutical process development, manufacturing, and analytical development/quality control is essential.
• Bachelor's, Master's, or PhD in Life Sciences, Pharmaceutical Sciences, Bioprocess or Chemical Engineering, or a related science. The ideal candidate will have 5+ years of project management experience in the biotech/pharmaceutical industry.
• 2-3 years of experience with MS Project software and/or other project management software.
• Working experience in negotiating and executing process and product development activities and contracts.
• Working experience with progressing development and manufacturing contracts and master service agreements.
• Ability to travel (domestic/international) approximately 25-30%.

Desirable:

• Knowledge of the animal health industry and drug development timelines.
• Working knowledge and understanding of industry trends for large molecule product development and manufacturing.
• Working knowledge of lean and/or Six Sigma operations.
• PMP certification.