Job Description

Head of CMC (id 1845)

Belgium Biotechnology Employee
Posted by Luc Decat on 28/10/2020

Novellas Healthcare is looking for a Head of CMC  (chemistry, manufacturing, control) for a clinical stage biotechnology company, pioneering a new class of therapeutic agents. These are targeted, microbe-based, specifically
designed agents that express and locally deliver potential disease-modifying therapeutics at disease
sites. The company have a strong R&D pipeline and an extensive portfolio of agents advancing toward clinical development.

MISSION:
The Head of CMC will be responsible for CMC-related activities across the product portfolio including
process development, (pre-)formulation, manufacture and supply of clinical trial materials. The ideal
candidate will be a highly motivated individual with experience and interest in working in a small,
entrepreneurial environment with a broad set of responsibilities and opportunities.

JOB DESCRIPTION:

  • Overall responsibility for all CMC activities from preclinical development through delivery of clinical drug supplies for early to late-stage clinical drug candidates
  • Identification, selection and management of Contract Manufacturing Organizations (CMOs) for process development, cGMP manufacture and supply of Drug Substance DS) and Drug Product (DP) in support of ongoing clinical programs
  • Lead DS/DP formulation & process development and execution of all CMC activities in view of business needs in a rapidly changing business environment
  • Develop, execute and communicate CMC development strategies and project plans in close collaboration with Project Teams
  • Lead CMC project planning, budget, identify scientific/project risks and work with Project Teams to create mitigation plans
  • Execute plans for registration and validation of DS and DP as required by cGMP, ICH and FDA regulations
  • Ensure that master service agreements and quality agreements are in place in a timely manner, in cooperation with the legal & quality departments
  • Evaluate stability data; adjust and implement bulk supply strategies as needed
  • Prepare, review or edit cGMP batch records, CMC SOPs, CMC Regulatory and Quality
    documents
  • Writing and reviewing CMC documents for IND/CTA submissions; represent the company as the CMC expert for US and European regulatory and business interactions
  • In coordination with Quality Assurance (QA), implement stage appropriate analytical
    methods and ensure that the CMC/QA/QC teams and all CROs and CMOs are using systems and processes in compliance with applicable regulatory standard
  • Collaborate with QA & QP to build in quality & compliance throughout development
  • Actively contribute to improve quality management system

 

REQUIREMENTS & QUALIFICATIONS:

  • A Master or PhD degree in Pharmaceutical Sciences, Biotechnology, Bioscience Engineering or related scientific discipline
  • A minimum of 10 years of experience in pharmaceutical or biotech industry and at least 5
    years in drug development
  • Substantial experience in managing International CRO/CMOs for the manufacture of cGMP DS and DP
  • Substantial experience with projects at different stages of clinical development including
    multiple pharmaceutical dosage forms (e.g. capsules, tablets, topicals, etc.)
  • Strong expertise in the field of biological DS/DP manufacturing and characterization.
  • Experience with live biotherapeutic products is a plus.
  • In-dept understanding of clinical drug development, cGMP manufacturing, analytical
    development, supply chain management and IND/CTA and BLA/MAA filings; thorough
    knowledge of relevant FDA and EMA regulations
  • Experience with implementing technical, strategic and operational plans
  • Entrepreneurial mindset with positive attitude
  • Being able to work independently and to collaborate with and direct internal/external teams on assigned projects
  • Ability to identify and resolve critical issues and to quickly adapt in changing demands and business environment
  • Excellent written and verbal communication and organizational

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