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Position:
Associate Director, Commercial Stability San Mateo, CA • QC & Analytical

Employer:
ADC Therapeutics

Description:

Company Profile

Founded in 2011, ADC Therapeutics is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers with significant unmet need. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to pivotal Phase 2 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development. 

 The Company has recently successfully completed an initial public offering (IPO) and its commercial organization is building the pre-launch market activities. There are operations in Lausanne Switzerland (Head office and Clinical), London UK (R&D), New Jersey US (Clinical and Commercial) and San Francisco US (CMC manufacturing). For more information please visit the company website www.adctherapeutics.com.

 

Position Overview

The successful candidate is responsible for leading a commercial stability team that would oversee global stability programs for ADCT at CMOs and contract testing laboratories. The candidate will be responsible for contributing to key functional, tactical, and operational aspects of the commercial stability group at ADCT. Knowledge of cGMP and filing regulations, guidelines, industry practices, and trends pertaining to the manufacture and stability testing of biologics is a requirement. The candidate must have excellent written and verbal communication skills.

Job Responsibilities

  • This individual will provide technical expertise and execute stability program activities of commercial biologic and pharmaceutical products
  • Activities include protocol authoring, LIMS study approval, stability data evaluation and trending, expiry dating of products and authoring stability reports
  • Critically review stability documents for consistency and quality
  • Work in collaboration with regulatory sciences, CMC teams and technical experts to author CMC stability sections of initial and post approval HA submissions
  • Respond to HA stability questions
  • Complete and close all stability studies
  • Author APQR and present the data at internal meetings
  • Act, escalate, identify information regarding stability programs that may impact product studies or regulatory commitments directly and promptly to line management
  • Approve, identify, write and revise stability related SOPs.
  • Serves as resource for deviations, investigations, OOT/OOS, and CAPAs for stability related quality events.
  • Capture, measure, and report critical performance and compliance metrics related to stability testing, review, and approval cycle times and investigations


Qualifications/Experience:
  • Prior experience with stability programs and demonstrated expertise in Biologics, Pharmaceutical, or Protein Therapeutic molecules
  • Knowledge and understanding of ICH Guidelines (Q1A, Q5C), US/EU/ROW stability requirements, and industry best practices 
  • Thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a biologics or pharmaceutical manufacturing facility.
  • Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
  • Hands-on experience authoring stability sections for submissions, technical assessment of stability specification changes, and stability investigations.
  • Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment
  • Strong leadership and decision-making skills
  • Experience with evaluating and interpreting stability data using statistics and statistics software 
  • Data entry and verification experience in the electronic laboratory information management system (LIMS) 
  • Strong computer, scientific, and organizational skills
  • Minimum of 5 years (PhD)/ 10 years (MS) /15 years (BS) relevant cGMP experience in biopharma


Location: San Mateo, CA

Contact: recruiting@adctherapeutics.com

Post Date: 2/17/2021 1:37:35 PM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 5/10/2021; Admin Logon
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