Sr Director, Head CMC Development

  • Location

    Germany
  • Salary

    Negotiable
  • Job Type

    Permanent
  • Functions

    Technical Operations

Sr Director, Head of Late-Stage CMC Development

Berlin

Summary

Advancing a new era of medicines to address the challenges faced by patients with limited treatment options, leveraging a unique technology platform for the creation of cutting-edge therapeutics.

They are currently expanding a diverse pipeline of innovative RNA-based therapies, focusing on genetic diseases. Their wholly-owned pipeline prioritizes high unmet needs in hematology, cardiovascular, and rare diseases.

Role Purpose

Accountable for the progression of Late-Stage CMC Development Programs (Phase II and beyond), encompassing devising/implementing CMC strategy, executing manufacturing plans, overseeing Contract Manufacturing/Testing Organizations for Drug Substance (DS) & Drug Product (DP), coordinating analytical lifecycle activities, and executing Regulatory strategies.

There will be substantial engagement with Contract Manufacturing Organizations (CMO’s), so a comprehensive understanding of cGMP regulations, and awareness of Regulatory requirements for therapeutic development, will be important.

Oversight of the delivery of DS and DP, ensuring quality, cost-effectiveness, and close collaboration with CMC project managers and core teams.

Responsibility for planning, budgeting, and executing activities with limited support. You will actively participate in forward-looking strategic processes and serve as the external representative with CMOs, Scientific organizations, and partners.

Working Relationships

Internal: Executive Leadership, Project directors, Supply Chain, GMP/GCP Quality, Non-Clinical Development, Clinical Operations, Clinical Science, Project Management, Regulatory Affairs, Legal and Finance

External: CMO’s/CDMO’s, Regulatory authorities, partners, Scientific Organizations, and consultants.

Responsibilities

  • Management and support of CMC Project Leaders, overseeing late-stage programs.
  • Development of Late-Stage CMC Development strategies emphasizing rapid, high-quality, and cost-effective program evolution.
  • Oversite of CMOs, involving MSA/QTA negotiation, SOW review and negotiation, participation in JSCs/working team meetings, and managing transactions as needed.
  • Collaboration with GMP QA to ensure high-level compliance in the manufacturing network.
  • Collaboration with Early-Stage CMC Development for smooth hand-over of program responsibilities, as required.
  • Proactively drive production process improvements for enhanced yield and robustness, optimizing costs.
  • Responsible for CMC project management activities from Phase 2 through Phase 3.
  • Execution of RNA project activities, including drug substance and drug product manufacturing, process and analytical development, scale-up, and clinical product manufacturing.
  • Collaboration with relevant SMEs to ensure analytical lifecycle requirements are met at CMOs.
  • Ensure accurate forecast requirements for proprietary starting materials are communicated to internal support organization.
  • Assist in the resolution of Product Quality Investigations by providing Technical Input.
  • Identification, communication, and mitigation of relevant business and quality risks.
  • Ensure generation and archiving of scientific reports, regulatory documentation, IP, and status reports according to relevant guidelines.
  • Contribute to/review relevant CMC regulatory documentation for IMPDs, INDs, Briefing Documents, etc.
  • Represent the company at conferences.
  • People and functional budget management.
  • Allocate necessary resources to support the creation, review, administration of plans, protocols, records, reports, SOPs, risk assessments, dossiers, contracts, presentations related to development, production, analytics, quality assurance, supply chain activities.
  • Contribute to the development, optimization, and maintenance of processes, standards, and systems within CMC department.

Experience and Education

  • Advanced University degree in Chemistry, Pharmacy, or a similar natural science, preferably PhD.
  • Extensive experience in the biotech/pharmaceutical industry with strong demonstrable managerial experience.
  • Extensive experience in GMP Manufacturing of DS and DP, oligonucleotide, or peptide synthesis (small molecule or biologic experience will be considered), GMP QA principles, Project Management, and execution, CMO oversight, and interaction.
  • Working understanding of late-stage drug development process and Health Authority expectations.
  • Experience including pharmaceutical tech transfer, production scale-up, manufacturing process characterization validation, preparation of complex CMC-related documents for regulatory submissions.
  • Skills/Competencies
  • People management and leadership competencies, and capable of working independently with limited guidance.
  • A collaborative working style, focus on relationship building, strong influencing skills, and excellent stakeholder management.
  • Strong budgeting/financial skills and business acumen.
  • Proven team and goal-oriented person with a strong focus on quality, details, and the ability to drive multiple activities from inception to completion.
  • Excellent written and spoken English language skills.

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