Senior Project Manager - CMC, Biologics
- Employer
- Barrington James
- Location
- Switzerland
- Salary
- up to 160,000
- Start date
- 27 Sep 2019
- Closing date
- 27 Oct 2019
View more
- Discipline
- Regulatory Affairs, CMC, Project Management, Manufacturing Project Management, Quality Project Management, Regulatory Project Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
RESPONSIBILITIES:
Lead late 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 as well as Process Characterization 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 deliverables
Serve as a point of contact for CMOs and CROs related to DS and DP manufacturing
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 Compound Development Team ensuring alignment between the CMC activities and the Program strategy and requirements and providing updates and proposed CMC strategy to the Program Team
REQUIREMENTS:
MSc/PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline with 10 years or more of relevant biologics CMC (including project management) 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/validation
Experience with drug development of Antibodies
Experience with late stage development (Process Characterization and PPQ)
Experience with PFS - preferred
Proficiency in state of the art project management tools
Competencies: Disciplined, shows initiative, excellent planning and organizing, excellent communication, customer-oriented, persuasive, problem analysis and solving, results orientated, teamwork, decisiveness
Fluency in English, both written and spoken
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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