TRL is a research organization that has transformed itself to refocus its discovery efforts on biological agents for the treatment of autoimmune diseases. The mission of the 'New TRL' is dedicated to improving the lives of people around the world through the creation of new and novel biologics.

At TRL, we look for talented individuals who have a high level of commitment to science and who want to be part of an entrepreneurial environment. We seek people who are inspired by our mission and want to make a difference in people's lives.

Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to becoming a great place to work. We provide excellent compensation and benefits and a collaborative environment that fosters respect and scientific excellence.

The individual researchers we hire should be willing to push boundaries and be open to new ideas; bring an optimistic and solution-oriented mindset; work with honesty and integrity; take ownership and accept accountability; execute with a sense of urgency; build and maintain a team oriented discipline and celebrate success.

Positions



Analytical R&D Scientist II

Tanabe Research Laboratories is dedicated to the discovery and development of effective biological drugs that will meet future medical needs for oncology and other serious medical conditions.

We currently have an open position and an excellent opportunity for a motivated and ambitious scientist to join our Analytical Research & Development group. The scientist will have many opportunities to make a meaningful contribution across a broad spectrum of critical areas, including discovery research, lead compound selection, IND-enabling studies and preclinical development of monoclonal antibodies, antibody-drug conjugates (ADCs), and other biologics. Job activities will include formulation studies, process development, biochemical/biophysical characterization, analytical method establishment, and other CMC-related activities necessary to support IND filings. The scientist will be responsible for developing downstream purification processes and robust analytical assays, writing tech transfer documents, and managing the transfer of these protocols and methods to GLP/GMP vendors. In addition, they will perform and supervise in-process testing of intermediates during process development and scale-up prior to GMP manufacturing. The scientist will also be responsible for designing, supervising, performing and troubleshooting complex analytical and formulation issues that occur during research and development of monoclonal antibody, ADCs and other biologics. They may also be required to supervise junior RAs

TThis position requires a Ph.D. in chemistry, biology, biochemistry, or other relevant discipline, with 3-5 years of industry experience. The successful candidate will have a strong background of scientific principles and concepts, and must have hands-on expertise in critical analysis of complex data and the ability to interpret and integrate experimental results with project objectives. Extensive experience in therapeutic antibody research is essential; experience working with ADCs and previous MS experience or expertise is preferred.

Excellent communication skills, the ability to work in a goal and team-oriented setting, well developed organizational skills, and the ability to thrive under pressure are also required.

Qualified candidates may submit their resume to


Director Drug Development

Tanabe Research Laboratories is dedicated to the discovery and development of effective biological drugs that will meet future medical needs for oncology and other serious medical conditions.

We currently have an open position and an excellent opportunity for a motivated Director of Drug Development to join our Development team. The Director will have many opportunities to make a meaningful contribution to the programs at TRL within the growing ADC and antibody portfolio and be responsible for the development, implementation, and oversight of effective strategies to supply drug product for clinical needs. This includes manufacturing, supply chain, procurement and distribution activities, as well as preparation of CMC sections for regulatory submissions. The Director is also responsible for participating and supporting novel biologic drug development projects working with antibodies, alternative scaffold proteins, or other non-small molecule entities targeting oncology or other diseases.

Direct responsibilities also include the development and implementation of comprehensive strategies for formulation and packaging development of parenteral drug products. Management oversight for: development & production activities at CMOs and provide technical support and troubleshooting; management of contract manufacturing organizations (CMOs) to produce Drug Product supply for non-clinical studies and clinical trials; upstream and downstream process development for manufacture of monoclonal antibodies, bispecifics and Fc fusion proteins; and, analytical test method development, qualification/validation, and transfer between CMOs and contract research organizations (CROs). The Director will have direct responsibility for supply chain logistics for drug product manufacturing activities including reviewing & providing input into quality agreements, master & executed batch records, and manufacturing deviations and investigations. Interface effectively with other team members and support operational budgets, cost controls and resource planning to meet corporate strategic objectives. Review and approve CMC portions of manufacturing process documentation for compliance with cGMP and other appropriate regulations and guidelines. Participate and support Company’s regulatory submission efforts and prepare technical reports in support of planned regulatory submissions.

This position requires a BA/BS in pharmaceutical science, chemical engineering or other related scientific discipline and 10+ years of hands on experience with increasing responsibility in biopharmaceutical development. In addition, a successful track record in selection and management of CROs/CMOs including site qualification, technical transfer, clinical supply logistics and oversight of activities. Must have experience in writing CMC documents for regulatory submissions (IND/BLA) and a strong understanding of pharmaceutical development, quality and regulatory issues. Must have hands on working experience with early stage (up to phase II) of drug development, as well as in-depth knowledge and full understanding of GMP requirements and CMC regulatory requirements for ADCs. A familiarity with phase III/commercial development is a plus. Excellent communication skills, the ability to work in a goal and team-oriented setting, well developed organizational skills, and the ability to thrive under pressure are also required.

Qualified candidates may submit their resume to


Director Clinical Operations

Tanabe Research Laboratories is dedicated to the discovery and development of effective biological drugs that will meet future medical needs for oncology and other serious medical conditions.

We currently have an open position and an excellent opportunity for a motivated Director of Clinical Operations to join our Development team. The Director will have many opportunities to make a meaningful contribution to the programs at TRL within the growing ADC and antibody portfolio by providing management and daily execution to the newly established clinical program. Responsibilities include developing the infrastructure to support clinical trials, operational leadership and successful execution of clinical trials according to regulatory guidelines, oversight of CROs, timelines, budgets, resources, clinical trial sites, vendors and key project deliverables; oversight and continuous improvement of department infrastructure through the development of SOPs and guidelines. The Director will also be responsible for contributing to strategic planning to ensure optimized clinical development plans for assigned projects in alignment with company goals; ensuring operational feasibility of clinical development plans and scenarios; and, ensuring all study activities are completed in accordance with country specific ICH GCP, health authority regulations and necessary TRL SOPs. In addition, will drive clinical activity including resourcing, staffing, direction and action plans and develop, implement and maintain standards across clinical studies within a program. Director will also coordinate the preparation and finalization of clinical aspects of IND submissions: providing technical expertise (along with clinician consultant) for the development of clinical documents, including prioritizing, authoring, and approving study activities (i.e. protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.

This position requires a BA/BS in related scientific or healthcare field and 10+ years progressive clinical operation experience gained working in pharmaceutical or biotechnology industry environment, with a strong preference for antibody/biologics/ADC experience, including supervisory experience managing clinical operations staff. The successful candidate will have experience in a hands-on early development role within a small organization and a proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors. Experience managing the clinical operations for drug across multiple therapeutic areas is a plus with emphasis on Oncology. Excellent communication skills, the ability to work in a goal and team-oriented setting, well developed organizational skills, and the ability to thrive under pressure are also required.

Qualified candidates may submit their resume to

Please note we do not accept unsolicited resumes from any source other than directly from candidates.

TRL is proud to be an Equal Opportunity Employer. We will always select the most qualified candidate regardless of race, color, religion, national origin, ancestry, sex, gender, gender identity, age, medical condition, sexual orientation, marital status, citizenship, pregnancy, physical or mental disability, genetic characteristics, veteran or other protected status.