Senior Scientist, Analytical Development

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Description

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.

We are seeking a Senior Scientist, Analytical Development to join ADCT's QC & Analytical team.

Why ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a rapidly growing commercial-stage biotechnology company that is improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs) for patients. ADC Therapeutics' CD19-directed ADC ZYNLONTA™ (loncastuximab tesirine-lpyl) was approved by the FDA on April 23, 2021 for the treatment of adult patients with relapsed and refractory diffuse large B-cell lymphoma.

To learn more about ADC Therapeutics, please visit us at and follow us on Twitter and LinkedIn.

What You'll Do:

Lead and support Analytical Development activities related to analytical method development, product characterization and comparability assessment for multiple early-stage and late-stage programs of the ADC Therapeutics. This role will report to the Director of Analytical Development.

* Work in a team environment to manage and co-ordinate analytical development activities between contract testing labs, CMO and ADCT
* Develop, improve, and implement platform methodology for release/stability and characterization testing for ADCT products
* Manage product characterization and analytical comparability assessment activities
* Author and review analytical documents including but not limited to protocols, reports, procedures and certificates
* Write and review analytical sections in regulatory submission documents (e.g. IND, IMPD, BLA)
* Work closely with Quality Control in analytical method implementation, qualification/validation, and transfer. Serve as a technical expert to aid in analytical investigations and assay trouble shooting in routine GMP Quality Control testing.
* Be a key member of the interdisciplinary CMC project teams.

Requirements

Who You Are:

* Bachelor's degree required. Prefer candidates with a Master's and/or PhD in Biochemistry, Chemistry, a BS/MS degree
* 5+ years of industry experience in (bio-) pharmaceutical manufacturing and testing
* 5+ years' experience in Mass spectrometry, chromatography (e.g. SEC, RP-HPLC, IEX), and capillary electrophoresis (e.g. icIEF, CE-SDS) techniques for protein therapeutics
* Experience with structural characterization of both large and/or small molecules
* Experience in analytical method development and qualification/validation for GMP quality control testing
* Experience with antibodies, highly potent cytotoxic active pharmaceutical ingredients and/or antibody drug conjugates is a strong plus
* Hands-on experience with outsourcing of assay development, stability and quality control in support of CMC activities
* Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions
* Excellent communication skills for both written and verbal presentations
* Strong and proven leadership capabilities related to project management
* Self-motivation, enthusiasm and ability to interact within a multi-disciplinary team across multiple locations.
* Ability to articulate issues to management in a timely manner
* Experience in working in entrepreneurial stage companies
* Demonstrable ability to work proactively and independently, tenacious when necessary.
* Self-motivated, goal driven with a pragmatic, hands-on approach.
* Positive, professional team member
* Strong organizational skills
* High quality standards
* Excellent oral and written communication skills.
* Creative problem-solving skills.

ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional and respectful work environment where employees are empowered for success.