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CMC & Regulatory Lead (H/F/X)

June 12th 2023

Exothera is a contract research, development, and manufacturing organization (CRDMO) dedicated to virus, viral vector, and nucleic acids production. As a Univercells company, Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated discovery services as well as process development/optimization to rapidly reach GMP clinical and commercial production of viruses, viral vectors, and nucleic acids. At Exothera and Univercells, our mission is to make health equally accessible to all.

Mission Description

As CMC and Regulatory Lead you will be responsible for driving the CMC strategy within internal and external projects through their lifecycle, and for delivering on CMC-related specific client requests to projects (e.g., writing or reviewing of CMC part of regulatory dossiers, comparability studies, providing regulatory input to answer Health Authorities CMC questions). You will also provide operational CMC&RA leadership inside the team and inside projects team and will support the sharing of regulatory knowledge at Exothera.

RESPONSIBILITIES

Projects

• You will take the lead in driving the CMC & Regulatory strategy for assigned projects from the project set-up, including the identification of relevant milestones and plans for their delivery. This includes but is not limited to:
  • Ensure alignment of operational activities with the Client’s CMC strategy, 
  • Develop written CMC plans/ strategies aligned with the Client’s strategy and with regulatory expectations for the type of product and the clinical stage,
  • Ensure the implementation of CMC recommendations received by the Client from Regulatory agencies and develop a tracker tool if appropriate,
  • Identify CMC risks and their mitigation approaches,
• You will ensure the delivery of CMC segments of the process [and product if/when relevant] development in a matrix environment. This includes but is not limited to:
  • Quality target product profile and identification of quality attributes and their criticality
  • Building of control strategy (product control and process control), including identification of required in-process controls, release, characterization, and stability tests, with justification for the set-up of action limits or acceptance criteria; identification of process performance attributes and process parameters (CPP, KPP, non-KPP) with their target control ranges, 
  • Analysis and interpretation of product and process development data 
  • Establishment of specifications for SM, DS, DP, diluent, placebo, and excipients,
  • Design/review of stability studies 
  • Writing and/or reviewing development plans/ reports, risk assessments, position papers, SOPs and any other technical reports required to support regulatory filings
• You will as well ensure the delivery of CMC part of regulatory files (for submission) as required to support the Client’s interactions with competent authorities, including and not limited to:
  • Author and/ or review appropriate CMC sections for regulatory files (CTA, IND, Scientific advice requests, pre-IND etc.),
  • Assemble the CMC documentation packages required by Clients for regulatory filings,
  • Assist in writing answers to CMC questions from Regulatory Agencies received during IND or CTA process if required by Clients, 
  • Author and/or review specific protocols/ reports required to support regulatory filling (e.g., comparability exercise, risk analyses, adventitious agents’ safety evaluation reports, any others as per client’s needs) 
• You will represent the voice of CMC & Regulatory team during project meetings (internal and external), report on CMC activities status in project team meeting and to Manager
• You will Identify the appropriate project contribution baseline (scope, timelines) and priorities

Team

• You will provide operational supervision and/or teaching to CMC & Regulatory Associate for alignment on the interpretation of regulatory guidelines in accordance with ‘Teach/Lead’ value 
• You will participate in the dissemination of CMC requirements within the field of viral vectors inside the CMC & Regulatory team and inside the projects team in accordance with the ‘Teach/Lead’ value

Knowledge sharing and regulatory surveillance

• You will participate in regulatory surveillance around viral vectors-based products, and maintain an up-to-date registry of regulatory references, including its sharing in accordance with the ‘Teach/Lead’ value of Exothera
• You will write position papers or in-house guidance as per internal needs

Candidate profile

• PhD or MSc (or equivalent) in life sciences (or chemistry, or pharmacy) or related discipline
• At least 4 years of direct experience in CMC or regulatory fields in the biotherapeutics/biopharmaceutical/biotech or pharmaceutical industry
• Experience with viral-based gene therapies and/or viral vaccines
• Scientific Knowledge of viral vectors development (process and product) principles, as well as demonstrated understanding of general pharmaceutical development concepts (e.g., quality by design, design of experiment, analytical development, drug substance and product manufacturing)
• Experience in authoring IMPD and/or CMC section for IND and/or BLA, and/or in authoring CMC part of Scientific Advice requests
• Experience in direct interactions with Regulatory Authorities is an asset
• Strong knowledge of regulatory guidelines (EU, US, ICH, WHO), in particular in the field of viral vectors for Vaccines and Gene Therapies
• Good knowledge of EU and US pharmaceutical regulations (GMP)
• Full professional proficiency in English is a must (written and verbal)
• Scientific writing skills
• Ability to move forward multiple projects simultaneously with stringent timelines.
• Strong communication, presentation, and listening skills
• Problem-solving and negotiation skills

Offer

CMC & Regulatory Lead (H/F/X)

Contact Details

https://exothera.world/our-values/open-positions/cmc-regulatory-lead-exothera/