Overview
Location: CB4 0WE, Cambridge, England, United Kingdom
Duration: 12 months
Flexibility: At least 50% of the time in the office after initial induction period.
This is NOT a fully remote role.
Responsibilities
- Experience of working in a team within a matrix management structure within a larger organization
- Knowledge and experience of tech/design transfer activities for medical/pharma products moving from R&D into production
- Experience of inputting into and writing manufacturing related sections of DHF documentation
- Knowledge and experience in supplier management and capital equipment acquisition
- Knowledge and experience of process development tools and industry accepted risk management and validation methods
- Provide expertise and input into device scale-up activities including DFM; DFA, precision component moulding and assembly.
- Specialist expertise knowledge area in one or more of the following:
- DFM/precision medical component moulding
- Combination products including sterile injectables, selection, fill-finish and assembly
- Secondary & Tertiary packaging for medical/pharma products, development and manufacturing
Qualifications
- Proven track record (5+ years) in development of medical devices and /or combination products within a pharmaceutical, medical devices, and/or combination products setting with significant cross-functional team management responsibilities.
- Significant career examples working in matrix teams
- Track record of goal-driven behaviour, problem-solving, ability to make pragmatic decisions, readiness for new challenges
- Given examples of complex projects involving tech transfer of MedTech products where candidate played a significant role
- Significant experience of interfacing with leading MedTech CMO's and capital equipment suppliers whilst representing a professional organisation. Ability to lead and control interactions to achieve desired outcomes
- Demonstrable experience of implementing industry standard guidance's and tools (ICH Q8,Q9,Q10 ISO13485, ISO14971, cGMP, CFR210/211 )
- Significant given examples of projects involving scale-up of complex precision MedTech products where candidate played a significant role
- Specific qualifications, training and/ or experience in the listed areas, backed
Overview
Location: CB4 0WE, Cambridge, England, United Kingdom
Duration: 12 months
Flexibility: At least 50% of the time in the office after initial induction period.
This is NOT a fully remote role.
Responsibilities
- Experience of working in a team within a matrix management structure within a larger organization
- Knowledge and experience of tech/design transfer activities for medical/pharma products moving from R&D into production
- Experience of inputting into and writing manufacturing related sections of DHF documentation
- Knowledge and experience in supplier management and capital equipment acquisition
- Knowledge and experience of process development tools and industry accepted risk management and validation methods
- Provide expertise and input into device scale-up activities including DFM; DFA, precision component moulding and assembly.
- Specialist expertise knowledge area in one or more of the following:
- DFM/precision medical component moulding
- Combination products including sterile injectables, selection, fill-finish and assembly
- Secondary & Tertiary packaging for medical/pharma products, development and manufacturing
Qualifications
- Proven track record (5+ years) in development of medical devices and /or combination products within a pharmaceutical, medical devices, and/or combination products setting with significant cross-functional team management responsibilities.
- Significant career examples working in matrix teams
- Track record of goal-driven behaviour, problem-solving, ability to make pragmatic decisions, readiness for new challenges
- Given examples of complex projects involving tech transfer of MedTech products where candidate played a significant role
- Significant experience of interfacing with leading MedTech CMO’s and capital equipment suppliers whilst representing a professional organisation. Ability to lead and control interactions to achieve desired outcomes
- Demonstrable experience of implementing industry standard guidance’s and tools (ICH Q8,Q9,Q10 ISO13485, ISO14971, cGMP, CFR210/211 )
- Significant given examples of projects involving scale-up of complex precision MedTech products where candidate played a significant role
- Specific qualifications, training and/ or experience in the listed areas, backed
#J-18808-Ljbffr…
