Senior CMC Project Manager / Associate CMC Project Director

☞ Ichnos Sciences

전망: 208

갱신일: 26-03-2024

위치: La Chaux-de-Fonds Neuchâtel NE

범주: R & D 과학 노동

산업: Biotechnology

수평: Director

직업 종류: Full-time

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작업 내용

Senior CMC Project Manager / Associate CMC Project Director

Job Description

ROLE OVERVIEW

In this position you will join an innovative CMC NBE drug development department with a strong track record of success in developing novel antibody therapeutics. The ideal candidate will have (strong) experience in project management within CMC early-stage development and knowledge of the elements that constitutes a CMC project; cell line development, process development, scale up, analysis etc.

RESPONSIBILITIES:

  • Lead early-stage CMC Development of NBEs as well as supporting potential new indications.
  • Project Manage and Lead the CMC core team including tech transfers and up scaling activities
  • Ensure alignment and follow-up with the functional leads/line managers (PS, MSAT, QC, QA, RA and clinical Operations) and external consultants for timely execution of deliverable.
  • Present project status/risks/mitigations etc. on a regular basis to senior CMC management team and relevant Global Stakeholders to secure alignment and structured decision making.
  • Author or review critical CMC documentation - CMC development plans, regulatory submissions, minutes of internal and external meetings, QTPP, risk assessments etc.
  • Prepare, follow, and adjust the CMC project budget and resource forecasting.
  • Manage CTM supply according to the clinical Development Plans as well as product disposition and inventory.
  • Serve as CMC representative in the Global Project Team ensuring alignment between the CMC activities and the Program strategy and requirements and providing updates and proposed CMC strategy to the Program Team.

EDUCATION AND DESIRED EXPERIENCE:

  • MSC/PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline with around 10 years relevant CMC experience in an industrial setting
  • In-depth knowledge of current GMP guidelines, familiarity with regulatory authority submissions (IMPD/IND/BLA), quality and technical agreement drafting (CMO)
  • Experience (hands-on or theoretical) in process/ analytical technology transfer and process scale up
  • Experience with drug development of Antibodies
  • Proficiency in state-of-the-art project management tools
  • Fluency in English
  • Personal competences: Disciplined, shows initiative, excellent planning and organizing, excellent communication, customer oriented, persuasive, problem analysis and solving, results orientated, teamwork, decisiveness

LOCATION:

You will join us, in a picturesque city of La Chaux-de-Fonds, Neuchâtel, Switzerland.

This is a rare opportunity to join our growing scientific team at the very start of something special. You will become a part of the foundation of a new company imprint…

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마감 시간: 10-05-2024

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