direkt zum Inhalt springen
Abdeckung

Jobs

 

Jobs & Karriere

Gestalten Sie einen der führenden Biotechnologieparks Deutschlands mit.

Silence Therapeutics GmbH

Director / Senior Director, Head of Late-Stage CMC Development

21.02.2024 / Silence Therapeutics GmbH seeks Director / Senior Director, Head of Late-Stage CMC Development

Our 20-plus years of RNAi experience together with our validated mRNAi GOLD™ platform make us a partner of choice for pharmaceutical companies looking to access the benefits of the siRNA and add this revolutionary modality to their discovery pipeline. As pioneers in the design and development of siRNAs (short interfering RNAs), Silence Therapeutics is advancing a new generation of medicines to potentially address the needs of patients who have limited or inadequate treatment options. 

Our mission is to use our technology to create a new generation of therapeutics that can improve patient outcomes and, in the process, build shareholder value. 

We are developing a deep pipeline of innovative siRNAs based on our mRNAi GOLD™ platform for diseases with a genetic basis. The depth and versatility of our liver-targeting technology gives us the opportunity to address a wide range of conditions in virtually any therapeutic area. Our wholly-owned pipeline is currently focused in three therapeutic areas of high unmet need: hematology, cardiovascular, and rare diseases.  

Role Purpose

This position is directly responsible for advancement of Silence Therapeutics Late-Stage CMC Development Programs (Phase II and beyond).  This responsibility includes development and implementation of CMC strategy, execution of manufacturing plans, management of Contract Manufacturing/Testing Organizations for Drug Substance and Drug Product, coordination of analytical life cycle activities (in partnership with relevant internal SMEs) and execution of Regulatory strategies. The incumbent will be a member of the CMC Leadership Team and contribute to its effectiveness.

The position requires significant external contact with Contract Manufacturing Organizations (CMO’s), understanding of cGMP regulations and awareness of Regulatory requirements for the development and commercialization of therapeutics for human use.

This person in this position will be responsible for delivery of DS and DP according to state-of-the-art scientific principles, at the right quality, with manageable cost in close collaboration with CMC project managers and Silence project core teams.

As Director you have the full responsibility for planning, budgeting, and execution of planned activities with limited support. You play an active role in the forward-looking strategic process, are the external representative for the company in contacts with CMO, Scientific organizations and partners.

Working Relationship:

  • Internal contact points: Executive Leadership, Project directors, Supply Chain, GMP/GCP Quality, Non-Clinical Development, Clinical Operations, Clinical Science, Project Management, Regulatory Affairs, Legal and Finance
  • External contacts: CMO’s/CDMO’s, Regulatory authorities, partners, Scientific Organizations, and consultants.

Key Responsibilities

Functional responsibilities:

  • Management and support of CMC Project Leaders responsible for directing late-stage programs.
  • Development of Late-Stage CMC Development strategies with intent of rapid, cost-effective, and high-quality program evolution.
  • Management of CMOs to include: MSA / QTA negotiation, SOW review and negotiation, attendance to JSCs / working team meetings, managing transactions when required.
  • In partnership with GMP QA, ensure a high-level of GMP compliance in our manufacturing network.
  • Partners with Early-Stage CMC Development team to ensure smooth hand-over of program responsibilities when required.
  • Actively seek to drive production process improvements to improve yield and robustness while optimizing cost. 
  • Responsible for CMC project management activities for projects starting at Phase 2 through Phase
  • Responsible for execution of siRNA project activities, including drug substance and drug product manufacturing including process and analytical development, scale-up and clinical product manufacturing of siRNA compounds.
  • In cooperation with relevant SMEs, ensures analytical lifecycle requirements are met at CMOs.
  • Responsible for ensuring accurate forecast requirements for proprietary starting materials arecommunicated 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.
  • Secure generation and archiving of scientific reports, regulatory documentation, IP and status reports according to relevant guidelines.
  • Contribute/ review relevant CMC regulatory documentation for IMPDs, INDs, Briefing Documents etc.
  • Represents Silence Therapeutics at relevant conferences.
  • People and functional budget management.
  • Allocate necessary resources to support 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 development, optimisation and maintenance of processes, standards and systems within CMC department.

Person Specification

  • Advanced University degree in Chemistry, Pharmacy, or a similar natural science, preferably PhD.
  • 12-15 years of experience in pharmaceutical or biotech industry with at least 5 years of managerial experience
  • Broad experience in the following areas: 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 complex CMC-related documents for regulatory submissions.

Skills/Competencies

  • Drug Substance and Drug Product Manufacturing expertise.
  • People management and leadership competencies.
  • Capable of working independently with limited guidance.
  • Competent negotiator who seeks “win-win” outcomes for both parties.
  • A collaborative working style, focus on relationship building, strong influencing skills and excellent stakeholder management.
  • Strong financial skills and business acumen.
  • Proven team and goal-oriented person with strong focus on quality, details and ability to drive multiple activities from inception to completion.
  • Sense for practicality, identifying relevant details, problem-solving.
  • Excellent written and spoken English language skills.

If this sounds like the job for you, please send your cv and a cover letter to HR@silence-therapeutics.com

Silence Therapeutics GmbH

Alle Jobs im Überblick