Associate Director, Drug Substance Msat

vor 1 Woche

Zug, Zug, Schweiz Apellis Pharmaceuticals Vollzeit

Reports to:
Head of MSAT

Position Summary:


As part of the MSAT team, the Associate Director of Drug Substance, Manufacturing Science and Technology (MSAT), will assume broad responsibility for tech transfer, process qualification and validation at contract drug substance manufacturing sites.

The Associate Director of DS MSAT is responsible for process tech-transfer, scalability, PPQ, monitoring and optimization of processes, and manufacturability of drug substance and key intermediates.

The incumbent will bring deep and diverse expertise in manufacturing and related late stage and commercial affairs supporting other functional areas.

The position will provide technical support to Manufacturing and support a combination of late-stage lifecycle projects primarily and early-stage pipeline projects as appropriate.


Key Responsibilities Include:

  • Project member of internal or external projects (process implementation, validation, and tech transfers) as a MSAT technical expert.
  • Stewardship for products by coordinating the launch, tech transfer, validation and changes.
  • Manage risks and troubleshooting by participating in major deviations and handling of problems as requested by the supplier relationship team (SRT).
  • Manage development and manufacturing activities, ensuring close partnership through open and transparent communication, scientific and strategic understanding, and attention to priorities and details.
  • Conducting technical transfer as well as lifecycle management planning & development from a manufacturing and scientific point of view.
  • Proactively anticipate, evaluate, and resolve technical challenges, major deviations and other problems within the area of expertise.
  • Ensuring manufacturing processes, facilities, equipment, raw materials and cleaning methods are qualified and where needed validated and maintained in a state of compliance with all GMP and global health regulations.
  • Partner with crossfunctional stakeholders (PM, QC, QA, Supply Chain and Regulatory etc.) to enable tech transfer, startup of new product lines, scale up and PPQ.
  • Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams.
  • Confirming the equipment qualification as a part of the process validation process (e.g. correct installation, efficient operation and robust performance).
  • Assess opportunities for continuous improvement of the manufacturing processes based on trend analysis, advances in manufacturing technology and controls and new industry standards.
  • Support evaluation of major deviations, rootcauseanalysis, corrective action preventive action (CAPA) and change control processes with strong focus on quality, risk mitigation and regulatory compliance.
  • Develop process for management of data and analysis of various operational parameters, including Annual Product Review (APR) and Continuous Process Verification (CPV).
  • Participate in the active writing and review of CTD Module 3 sections for regulatory submissions (NDA, PAS, etc).

Education, Registration & Certification:

  • College degree in life sciences / engineering or in a related area. Advanced degree (MS or PhD) preferred.

Experience:

  • Several years of progressive experience in cGMP development & manufacturing a strong scientific and technical background with experience in MSAT.
  • Knowledge of pharmaceutical processes, technology and systems along with significant process development, techtransfer scaleup, validation and manufacturing.
  • Extensive work experience in manufacturing science and technology (MSAT) or a related area.
  • Experience in process validations and lifecycle management activities.

Skills, Knowledge & Abilities:

  • Attention to detail and a handson approach towards project management tasks such as compilation of data, reports and presentations, dashboards and budget tracking.
  • Excellent technical computer skills, communication, comprehension, interpretation, problemsolving, team spirit, critical thinking and organization skills.
  • Demonstrated ability to work effectively in a team environment with the ability to effectively manage and build great relationships with external and internal collaborators.
  • Strong expertise with at least two different modalities (peptides, oligonucleotides, biologics, small molecules or gene therapy) is a plus.
  • Must have valid passport and must be authorized to work in Switzerland.
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