Orum Therapeutics (KRX: 475830) is a public biotechnology company developing TPD2®, a novel class of targeted protein degradation therapeutics. Also known as degrader-antibody conjugates (DACs), these therapeutics combine the precision of antibodies with Orum's novel degrader payloads to break down disease-causing proteins inside specific cells.

By enabling the selective degradation of previously “undruggable” targets, Orum is working to improve the effectiveness, safety, and reach of targeted protein degradation. The company’s lead programs target GSPT1, and it is also advancing next-generation payloads to expand the potential of its DAC pipeline.
In parallel, Orum is developing proprietary linker technologies to increase the flexibility and precision of future DAC programs.

With headquarters in Daejeon, South Korea, and Lexington, Massachusetts, U.S., Orum is globally positioned to deliver first-in-class cancer therapies for patients with hard-to-treat diseases. For more information, visit www.orumrx.com.

Industry: Biotechnology Research
Company Size: 51-200 employees

Orum Therapeutics

Savvy Admin PROD

Orum Therapeutics is seeking a highly motivated and accomplished scientist to lead the Bioanalytical (BioA) and PK/PD function. This role is designed for a technical expert who thrives at the intersection of large and small molecule analysis, specifically focused on the complex characterization of Antibody-Drug Conjugates (ADCs). As a key scientific lead, you will orchestrate the bioanalytical lifecycle — from internal method innovation to global CRO oversight — ensuring high-quality data generation in a GLP/GCP environment. Beyond assay management, you will serve as a strategic partner in project teams, leveraging pharmacokinetic modeling to translate data into actionable insights that drive candidate selection and program progression.

Principal Duties and Responsibilities

- Design and execute integrated Bioanalytical and PK/PD strategies for ADC programs, utilizing the three-analyte quantification approach (Total Ab, Conjugated, and Free Payload) from lead optimization to IND filing.

- Oversee in vitro and in vivo ADME studies, including payload metabolism, drug-drug interactions (DDI), and transporter assays, to define the metabolic fate of the ADC and the released payload.

- Provide high-level technical oversight for hybrid bioanalytical workflows, specifically bridging LBA and LC-MS/MS platforms to ensure robust quantification of complex modalities.

- Lead CRO selection and management, serving as the primary point of contact for method transfer, development, validation, and troubleshooting of proprietary assays under aggressive timelines.

- Review and approve SOPs, validation reports, and bioanalytical study plans in alignment with GLP/GCP standards and current FDA guidance.

- Act as the BioA/PK subject matter expert (SME) within multidisciplinary project teams, collaborating with Research & Development and Clinical teams to drive program milestones.

- Drive continuous improvement by evaluating emerging technologies to enhance the throughput and quality of ADC characterization.

- Execute an integrated role that bridges high-level scientific leadership and direct lab-based contributions, ensuring seamless translation from internal innovation to external CRO execution.

- Serve as the lead author for BioA and PK sections of regulatory submissions (IND/IB), ensuring full compliance with GLP/GCP and current FDA/EMA bioanalytical guidance.

**Skills, Abilities & Competencies**

- Extensive experience in pharmacokinetic (PK) and biodistribution studies of Antibody-Drug Conjugates (ADCs), including application of advanced bioanalytical methods such as LC-MS/MS for small-molecule quantitation and MSD-based ligand-binding assays (LBAs).

- Proven track record in developing, validating, and implementing bioanalytical assays for ADC modalities, including total antibody, free and conjugated payload, and anti-drug antibodies (ADA) assays, in support of preclinical and clinical PK studies.

- In-depth understanding of ADME principles and drug discovery/development workflows, including screening strategies from early feasibility through candidate nomination.

- Experience in non-compartmental analysis of PK data, with hands-on experience in PK/PD modeling and simulation, population PK analysis, and meta-analysis is a plus.

- Working knowledge of GLP and GCP regulations and their application within bioanalytical and clinical study environments.

- Demonstrated ability to operate independently in fast-paced biotech settings while effectively collaborating within cross-functional, global teams.

- Excellent communication, organizational, and time-management skills, with the ability to manage multiple priorities and deliver high-quality results.

- Strong work ethic with a high degree of accountability, initiative, and ability to work with minimal supervision.

Education

Ph.D. or equivalent degree in Analytical Chemistry or a related field with a minimum of 5 years' experience. Level will be commensurate with experience and accomplishments.

- U.S. citizens and those authorized to work in the U.S. (green card) are encouraged to apply. We are unable to sponsor/transfer at this time.

- Candidate must be able to pass a background investigation.

- Unable to work with 3rd party candidates or agencies.

~~To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.~~

~~Orum Therapeutics is an Equal Opportunity Employer (EOE). ~~

Bioanalytical Scientist

BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.

Industry: Internet News
Company Size: 11-50 employees

BioSpace

**Company Overview**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

**Role Summary**

The position will support and oversee analytical method development, method transfer and qualification, and overall management of CMC activities related to internal and external analytical testing and stability of antibody drug conjugates and intermediates. The Principal Scientist will lead analytical development for several preclinical programs, and direct method qualification for use in GMP production of clinical materials (Phase 1-3) with guidance from analytical leadership. This includes identification, selection, and setup of a central testing lab (CTL), and coordinating external activities related to analytical method development at the CTL and at various manufacturing organizations (CDMOs). This role works closely with key stakeholders within Technical Operations as well as across the company including Platform Research, Regulatory, and Project Management.

This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week.

**Primary Responsibilities Include**

- Oversight of all analytical aspects for bioconjugate drug substance and drug product as well as support for PMO and ASO oligonucleotides and small molecule intermediates including analytical method development, product quality characterization, technology and method transfer, analytical method qualification, in-process and release testing, and stability programs.

- Assist with developing the analytical strategy for complex biologics/bioconjugates guided by ICH frameworks.

- Identify and direct external cGMP laboratories conducting raw materials, intermediate and DS/DP product testing.

- Work with partner organizations and internal quality as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, OOS/OOT investigations, and CAPAs are initiated, addressed, and closed within target timeframes.

- Develop, review and approve method transfer/validation protocols and validation approaches.

- Author and review change controls, risk assessments and product specifications.

- Manage external CMOs and CTLs for the transfer and validation of analytical methods, product characterization testing and product release/stability testing.

- Advise and plan extended characterization of intermediates and drug substance to expand product understanding and impurity characterization.

- Support establishment of critical quality attributes, specifications, and overall control strategy.

- Partner with QA to provide oversight of cGMP-related activities and documents (change controls, deviations, CAPAs, procedures, batch release support, stability protocols and programs etc.)

- Support Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate.

- Support the development of regulatory CMC documentation including INDs, IMPDs and BLA as well as RTQs.

- Support internal analytical wet lab work as needed and the development and expansion of the internal AD/CMC lab.

**Education And Skills Requirements**

- PhD or equivalent experience in a scientific discipline.

- Minimum of 8 years of experience in Analytical Chemistry preferably in a clinical-stage biotechnology company.

- Knowledge and hands-on experience with a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and mass spectroscopy.

- Strong experience with bioconjugates/ADCs a plus.

- Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment.

- Excellent interpersonal, organizational, negotiation, and communication skills; a team member that can work collaboratively with colleagues across functions.

MA Pay Range

$159,000 - $195,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

~~Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.~~

Principal Scientist, Analytical Development

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