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 an Executive Director, CMC Biopharma Commercial Outsourcing. The position will report into the Chief Development Officer and will be based in Cambridge, MA.
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 Executive Director, Chemistry Manufacturing and Controls (CMC) Biopharma Commercial Outsourcing will provide the vision, leadership, strategy and management acumen to oversee the evaluation, selection, technology transfer and further expansion of company’s biologics CMC programs from a clinical stage to a commercial stage biopharmaceutical CMO. They will take ownership of all aspects surrounding the transition of the full breadth of CMC activities from clinical to commercial stage of manufacturing outsourcing, in order to advance key oncology programs through late stage development and marketing authorization.
The ideal candidate will be a highly motivated individual with hands-on experience working with commercial CMC Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and Contract Testing Labs (CTLs), and a keen interest in working in a small, entrepreneurial biotech with a lean team and a matrix–based environment, with broad responsibilities and opportunities.
This will be an opportunity to leave a ‘fingerprint’ on the forward development of medically important new cancer treatments.
The candidate will lead a team of 3-4 FTEs based in Cambridge, MA.
- Lead and oversee the Request for Proposal (RFP) process for the evaluation and selection of a commercial stage biopharmaceutical CMO for Trillium’s biologics programs.
- Lead, coordinate and manage the full transition, including technology transfer and further expansion of company’s biologics CMC programs from a clinical stage to a commercial stage biopharmaceutical CMO.
- Provide a nexus for communication between various departments and technical leads from the clinical stage CMO to the commercial stage biopharmaceutical CMO to ensure flawless and adequate product- and process-specific knowledge transition and manufacturing science transfer.
- Develop and implement a sustainable and adaptable late-stage/commercial CMC transition strategy for Trillium’s oncology portfolio.
- Ensure appropriate late-stage manufacturing process readiness, adequate product quality and cGMP compliance with all applicable global health authority regulations and expectations for marketing authorization.
- Develop close and trusted working relationships with commercial CMOs, CROs, CTLs and internal Trillium teams (Drug Development, Clinical Development, Quality Assurance, Regulatory Affairs, Program Management, Corporate Development and Translational Research) to implement in a timely and cost-effective manner Trillium’s product development and CMC control strategies.
- Develop, maintain and implement internal and external processes to satisfy CMO’s contractual and regulatory requirements for commercial CMC readiness.
- Set strategic objectives for commercial CMC readiness in alignment with corporate objectives and ensure that targets are achieved.
- Proactively identify potential risks to commercial CMC readiness timelines and deliverables and implement effective risk management plans and mitigation strategies.
- Represent commercial tech transfer CMC team at leadership meetings and board discussions.
- Provide input into regulatory affairs strategy, regulatory filings and meetings with relevant health authorities, ensuring the appropriate reporting, analyses and compliance of CMC sections.
- Maintain commercial tech transfer CMC budget in adherence to corporate strategy and the overall goals and objectives of the company.
- Ensure active senior management engagement and full visibility to all commercial CMC tech transfer related activities including regular status updates for all programs.
- Work in compliance with the Trillium’s Code of Business Conduct and Ethics and all workplace policies, procedures and regulations.
- Advanced Degree (MS, PhD) is required in Biological Science, Chemistry or related technical discipline.
- Minimum of 15 years’ experience in the biopharmaceutical industry, with at least 10 years in a management capacity in a cGMP environment for manufacturing of biopharmaceuticals.
- Industry experience in a small biotech organization is strongly preferred.
- Extensive experience in managing US and international commercial CMOs/CROs/CTLs for the cGMP manufacture of biopharmaceutical drug substance (DS) and drug product (DP).
- Subject matter expert in CMC biopharmaceuticals drug development across all aspects of cell line engineering, process development, scale-up, formulation development, DS and DP cGMP manufacturing and technology transfer.
- Substantial experience with CMC biopharmaceutical drug development from late clinical development stage through marketing.
- Profound understanding and superior knowledge of cGMP regulations, FDA/EMA/HC/ICH guidelines related to CMC, along with experience in CMC regulatory filings for biopharmaceuticals.
- Broad and direct experience with FDA/EMA regulatory authorities’ cGMP inspections.
- Demonstrated ability to devise and execute integrated and structured CMC development strategies.
- Proficient in the analysis of scientific data with the ability to review scientific literature including reports, publications and regulatory submissions.
- Strong proficiency in MS Office Suite and additional computerized systems applicable for drug development setting and their respective compliance requirements.
- Must be willing to effectively lead and coordinate the transition and technology transfer to a commercial stage biopharmaceutical CMO with an exemplary “hands-on” approach.
- Ability to work with cross-functional teams and thrive in a matrixed, fast-paced and dynamic corporate environment.
- Able to interface well with all levels of personnel, including peers and other department heads in Drug Development, Clinical Development, Regulatory Affairs, Translational Sciences, Quality Assurance, Corporate Development, Program Management and develop strong and trusted working relationships.
- Capable of collaboratively engaging with external parties and vendors to effectively manage and oversee the transition and execution of all technology transfer activities while maintaining productive 3rd party relationships.
- Able to deliver high quality results across multiple projects and prioritize demands under tight timelines with competing priorities.
- Focused on practical, commonsense and sensible approaches to finding effective solutions while embedding strong quality and compliance behaviors and robust processes.
- Ability to proactively identify and mitigate risks while implementing technical, strategic and operational CMC plans.
- Strong and effective written and verbal communication skills, including excellent technical and scientific writing skills.
- Exceptional interpersonal skills, ability to influence and willingness to function in a global, dynamic and changing corporate environment.
- Highly versatile, with great attention to detail and demonstrated ability to multitask.
- Willing to accommodate flexible work schedule.
- Once routine travel resumes, willingness and ability to travel up to 50% of the time, including international travel.
How to Apply
Please send your resume and cover letter to email@example.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.