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 to recruit a Vice President, CMC Operations. The position will report into the Chief Development Officer and will be based in Toronto, Ontario.
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 Vice President (VP), CMC (Chemistry, Manufacturing and Controls) Operations will be responsible for leading and executing all CMC and related activities across Trillium’s biologics portfolio from pre-IND through to late clinical development stages. They will be responsible for the development and implementation of efficient and effective CMC regulatory strategies to ensure excellent process and product control in support of Trillium’s biologics products’ lifecycle management. They will take ownership of all aspects surrounding CMC activities, in order to advance key programs within the company’s oncology portfolio.
The ideal candidate will be a highly motivated individual with substantial CMC biopharmaceuticals experience, an exemplary “hands-on” operational approach and keen interest in working in a small, entrepreneurial biotech with a lean team and a matrix–based environment with broad responsibilities and opportunities.
- Develop and implement a sustainable and adaptable CMC strategy, lead CMC activities from pre-IND through to early and late clinical development stages, and ensure active executive management engagement and full visibility to all CMC-related activities including regular status updates for all programs at leadership team meetings and board discussions.
- Support the program teams to ensure the CMC strategy is aligned across the oncology portfolio.
- Ensure compliance within CMC to GMP and GCP standards.
- Provide input into the regulatory affairs strategy; lead the development, review and approval of all CMC sections in regulatory filings and also meetings with the relevant global health authorities (FDA/EMA/HC), ensuring the appropriate reporting and analyses of CMC sections.
- Enhance the departmental tools, systems and communication, in order to provide key input into the swift progression of pre-clinical drug candidates into first in human trials.
- Maintain CMC budget in adherence to corporate strategy and the overall goals and objectives of the company.
- Work with Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), Clinical Research Organizations (CROs) and internal teams including Drug Development, Clinical Development, Quality Assurance, Regulatory Affairs, Translational Research and Program Management to identify adequate product control strategies and ensure continuous improvement of manufacturing processes and product quality.
- Review of all CDMO documents, such as technical reports, batch records, protocols, change controls and other documents related to supply chain in support of clinical studies.
- Maintain an up-to-date understanding of all applicable regulations and industry standards for the development of biological products.
- Apply a “hands-on” operational approach across the full spectrum of CMC activities related to Trillium’s biopharmaceutical products including but not limited to cell line development, upstream and downstream process development/characterization/validation, analytical methods development/qualification/validation, formulation development, stability studies, product characterization and comparability, forced degradation studies, DS/DP cGMP manufacturing and clinical trial drug supply management across all programs at all stages of clinical development.
- Proactively engage in collaboration with internal and external stakeholders including Health Authorities and industry organizations to identify CMC trends and regulatory expectations in biopharmaceutical development and incorporate these into Trillium’s cost-effective and compliant CMC regulatory and development strategy and Quality Control (QC) approach.
- Develop, maintain and implement internal processes for CMC data collection, review, QC and archival, and for review and approval of all technical CMC documentation to satisfy contractual obligations and regulatory requirements.
- Oversee the development, validation and implementation of analytical methods for product release and stability programs and implement stage-appropriate process and product control strategies.
- Review and approve CMC QC investigations including change control (PR) investigations and corrective and preventative actions (CAPAs) implementation.
- Oversee, monitor and trend analytical methods performance and product stability data, confirmed out-of-trend (OOT) and out-of-specifications (OOS) results for shelf-life confirmation.
- Lead, coach, mentor and develop the CMC team and set the CMC objectives in alignment with corporate objectives to ensure specific targets are achieved and exceeded.
- Develop CMC department specific SOPs, processes and standards, including CMC vendor oversight program, in support of Trillium’s Quality Assurance (QA) and Quality Management System (QMS).
- Proactively identify potential risks to CMC timelines and deliverables and implement effective risk mitigation strategies.
- Oversee and manage external subject matter expert consultants in the area of CMC regulatory strategy, biopharmaceutical manufacturing process, quality control and compliance.
- Advanced Degree (Ph.D.) is required in Biological Science or related technical discipline.
- Minimum of 15 years’ experience in the Biotech/Pharmaceutical industry, with 10+ years in operational management capacity in a CMC/cGMP environment for biopharmaceuticals. Small biotech experience preferred.
- Substantial experience with cGMP manufacturing process for biopharmaceuticals from early clinical development stage through marketing.
- Demonstrated ability to devise and execute integrated and structured CMC development strategies.
- Subject matter expert in CMC drug development, across process, formulation, drug substance, drug product, scale-up and technology transfer.
- Profound understanding and superior knowledge of cGMP regulations, FDA/EMA/HC/ICH guidelines related to CMC, experience in the preparation of CMC regulatory filings for biopharmaceuticals and direct experience with regulatory authorities’ cGMP inspections and audits.
- Extensive experience in managing US and International CMOs/CROs//CTLs directly involved in or supporting cGMP manufacturing for DS and DP for biopharmaceuticals.
- Direct experience in leading a CMC operations team to oversee and manage the full spectrum of cGMP manufacturing activities for biopharmaceuticals while delivering stage-appropriate CMC control strategies and fulfilling applicable regulatory requirements for IND, CTA and BLA filings.
- Strong proficiency in MS Office Suite and additional computerized systems applicable for drug development setting and their respective compliance requirements.
- Willing to accommodate flexible work schedule.
- Once routine travel resumes, willingness and ability to travel up to 30% of time.
- Experienced leader with an exemplary “hands-on” operational approach to grow, develop, coach and mentor a functional CMC operations team.
- Ability to work with cross-functional teams (Drug Development, Clinical Development, Regulatory Affairs, Translational Sciences, Quality Assurance and Program Management) and thrive in a matrixed, fast-paced and dynamic corporate environment.
- Able to deliver high quality results across multiple projects and prioritize demands under tight timelines with competing priorities.
- Ability to proactively identify and mitigate risks while implementing technical, strategic and operational CMC plans.
- Strong and effective written and verbal communication skills, with excellent technical and scientific writing skills.
- Exceptional interpersonal skills, ability to influence and willingness to function in a global, dynamic and changing corporate environment.
How to Apply
Please send your resume and cover letter to firstname.lastname@example.org 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.