Project Manager, Drug Development CMC

Mississauga, ON / Cambridge, MA

Summary

Trillium Therapeutics is a clinical stage immuno-oncology company based in Cambridge, MA and Toronto, ON. Following recent promising clinical data updates and after raising over $300 million in 2020, the Company is now embarking on a substantial organizational scale-up to initiate a phase 2 program across a range of cancer indications. The Company is seeking Project Managers, Drug Development with focus on Chemistry Manufacturing and Controls (CMC) and currently has 3 openings for this role. The positions will report into a Senior Project Manager and will be based in either Mississauga, ON or Cambridge, MA.

The ideal candidate will be a highly energetic and motivated individual with a strong scientific and technical background and a keen interest in working in a small, entrepreneurial biotech with a lean team in a matrix–based environment with broad responsibilities and opportunities.

The Company

Trillium Therapeutics (Nasdaq:TRIL) is a clinical stage biotechnology company developing next generation immunotherapies targeting CD47, a checkpoint of the innate immune system. Immunotherapy is a rapidly evolving field that is redefining cancer care by harnessing a patient’s own immune system to eliminate tumor cells. First generation immunotherapies, targeting the adaptive immune system via T cell checkpoint inhibitors, have been enormously successful scientifically (2018 Nobel Prize), clinically (achieving real cure rates), and commercially (soon to be the largest drug class ever). CD47 is now emerging as one of the most promising next generation immuno-oncology targets.

Trillium has two highly differentiated CD47 blockers in development that – unlike other CD47 agents – have shown unique monotherapy activity across a range of hematologic malignancies. Under new leadership, Trillium has undergone a wide-ranging transformation program, including a major strategy reset. In 2020, the company raised over $300M, landed a strategic investment from Pfizer, and has been among the top performers on Nasdaq. Nearing completion of ongoing dose escalation studies, Trillium is now scaling up its organization to initiate a broad phase 2 program across several cancer indications.

The Position

Reporting to a Senior Project Manager (or similar), the Project Manager, Drug Development CMC, will be responsible for the hands-on operational execution, management and oversight of variety of CMC-focused activities supporting Trillium’s biologics product development. These activities include, but are not limited to planning, coordinating, directing CMC projects and the full spectrum of related activities outsourced to multiple external parties. Major components of the hands-on management of the CMC activities will include review, interpretation and archiving of data, batch records, protocols, study reports and other related technical documentation, tracking project timelines and budgets, and preparation, review, and management of CMC regulatory documentation. The position will be based in either Mississauga, ON or Cambridge, MA.

Accountabilities

  • Manage and provide operational support to drug development projects with emphasis on Chemistry Manufacturing and Controls (CMC) and CMC regulatory documentation.
  • Manage and coordinate with external parties performing outsourced CMC activities including but not limited to Contract Development and Manufacturing Organizations (CDMOs), Contract Testing Laboratories (CTLs), Subject Matter Experts (SMEs) and CMC regulatory strategy consultants. Work closely and manage relationships with these parties.
  • Review of all incoming CDMO documents, such as technical reports, batch records, protocols, change controls, and other documents related to drug supply chain in support of clinical studies.
  • Oversee all CMC quality control (QC) investigations at CDMOs from opening of an event until closure inclusive of implementation of all applicable Corrective and Preventative Actions (CAPAs).
  • Lead the preparation, management, review, QC and archiving of internal CMC databases.
  • Develop, maintain and implement internal and external processes to satisfy regulatory requirements for CMC data collection, integrity and archiving.
  • Develop projects timelines and study conduct plans, manage and coordinate effectively and efficiently assigned activities from start up to completion.
  • Where necessary ensure studies and activities are aligned with current Good Manufacturing Practices (GMP) regulatory guidelines, and where appropriate with current Good Clinical Practices (GCP) regulatory guidelines.
  • Proactively identify potential risks to CMC timelines, deliverables and budgets and implement effective risk management plans and mitigation strategies including issue escalation both internally and externally.
  • Prepare regular project status reports and maintain accurate and current details.
  • Manage and liaise with expert consultants in the areas of CMC regulatory strategy, analytical method development/qualification/validation and stability data trending/evaluation as required.
  • Function as a meeting facilitator between various internal and external teams and resolve conflicts as they arise using collaborative management skills.
  • Conduct site-monitoring, person-in-plant and audit visits at CDMOs/CTLs when required.
  • Contribute to the writing, compiling, review of CMC sections of regulatory documents, including but not limited to Investigational New Drug (IND) applications, Annual Updates, Clinical Trial Applications (CTA), CMC amendments to INDs and CTAs.
  • Survey FDA, HC, ICH regulatory guidance databases periodically to stay abreast of current regulatory guidelines.
  • Support development of CMC department-specific SOPs and standards, including CMC vendor oversight plans, in support of Trillium’s Quality Management System.
  • Other duties as necessary and required.
  • Work in compliance with the Trillium’s Code of Business Conduct and Ethics and all workplace policies, procedures and regulations.

Qualifications

  • Advanced Degree (MSc, PhD) is required in Biological Science, Biochemistry or related technical discipline.
  • Minimum of 5 years of progressive project management experience in a pharmaceutical or biotechnology drug development setting with emphasis on hands-on management of outsourced CMC activities; small biotech experience is strongly preferred.
  • Excellent knowledge and hands-on experience in all aspects of the manufacturing process and quality control for biopharmaceuticals with exposure to different scientific/technical CMC development areas (process development, analytical development, manufacturing, stability).
  • In depth CMC development knowledge in both early and late stage projects with sound understanding of all stages of drug development.
  • Excellent understanding of cGMP and FDA guidelines and regulations related to CMC.
  • Hands-on experience with regulatory filings for biologics (IND/IMPD, BLA/MAA).
  • Exceptional technical writing skills with CMC regulatory dossier experience considered a plus.
  • Exemplary ability to manage complex technical projects in collaboration with external parties including planning scope, allocating resources, defining timelines and tracking budgets.
  • Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project, MS Access).

Personal Attributes

  • Strong values-driven individual able to function in a diverse, cross-functional and multi-disciplinary team.
  • Must be willing and able to be “hands-on”, and thrive in a matrixed, fast-paced, dynamic and changing business environment.
  • Exceptional interpersonal skills and willingness to collaborate with others on assigned projects (including both internal teams and external parties).
  • Keen attention to detail and demonstrated ability to multitask.
  • Critical thinker with demonstrated ability to proactively identify issues and mitigate risks.
  • Highly versatile with ability to swiftly shift focus while attending to multiple competing priorities.
  • Willingness and ability to travel up to 25% of the time.

How to Apply

Please send your resume and cover letter to careers@trilliumtherapeutics.com with the title of the role in the subject line. Kindly note that phone calls and third parties are not accepted.

We thank all applicants for their interest. We will be reaching out only to candidates whose backgrounds most closely match our needs.