1. Job description
- Responsible for the overall coordination, execution, control and
completion of the Drug Substance and /or Product associated projects assigned.
- Ensuring delivery and development of projects upon business needs.
- Working in collaboration with the Head of R&D, the candidate
will work to develop and grow the capabilities, productivity, and quality
levels of the group.
- Duties will be variable depending on the nature of the projects to
be undertaken. These will mainly fall within the areas of CMC (drug product)
but may be concerned with: Cross-functional Project Management during
pre-clinical or clinical stage development of various pipeline assets.
Works on complex CMC (drug product) issues in which analysis of situations or
data requires an in-depth evaluation of diverse factors.
- May work either alone or as part of a CMC or cross-functional team
depending on the size and nature of project, and typically act as CMC liaison.
- If acting as Drug Product Lead, responsible for managing each
project and for monitoring and reporting progress and is accountable for all
matters relating to that project and for communication with the CDMO.
- Design and plan pre-formulation development / formulation
development experiments and troubleshoot existing protocols with or without
- Support external collaborating scientists in execution of
pre-formulation development / formulation development or CTM production.
Consolidate, generate and independently analyze multi-parameters data sets.
- Maintain and track well written and accurate research documentations
detailing work undertaken.
- Primary point of contact between Bridge Bio and the external
collaborator (e.g. CDMO, academia, KOL).
- Management of the designated project in accordance with the agreed
project planning and control documentation, including initiation and
maintenance of the project plan.
- Liaising with cross-functional teams as key Bridge Bio contact.
- Control of all project related documentation either in paper or
- Monitoring and advising on compliance with agreed budget relating to
- Responsible for the deliverables of the project.
- Master’s degree with at least 3 years of
pharmaceutical industry work experiences on formulation/preformulation OR
Doctorate Degree with at least 2 years of pharmaceutical industry work
experiences on formulation/preformulation.
- Extensive experiences pre-formulation / formulation / CTM
- Strong hands-on experience with particle sizer, Blenders, Roller
compactor, Extruder, Encapsulators, Tablet press, HPLC, Pan coaters, etc.
- Proficiency with Microsoft office applications.
- Excellent organizational, record keeping, oral and written
- Team player, detail oriented with excellent organization and time
management skills enabling support of multiple projects simultaneously.
- + 3 years of experience working on a drug development project team
from early discovery through clinical testing.
- Solid understanding of the applications, principles, concepts,
practices, and standards of pharmaceutical project management.
- Excellent interpersonal relationship skills and ability to liaise
successfully with internal and external project teams.
skills / written and spoken English.