Job opening - Sr Associate Scientist | Scientist TechTransfer and Life Cycle Management | Yacht Life Sciences| in Leiden

summary

leiden, zuid-holland
€5,750 per month
permanent

job category
engineering

job details

MSAT manages the process technology platform strategy for the production of biotherapeutics and vaccines in Leiden. They are responsible for Validation and Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of their commercial production processes.
The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
The (Sr Associate) Scientist is a member of the Manufacturing Science and Technology (MSAT) Team with the dedicated focus on:
1. New Product Introduction (NPI) / Life Cycle Management (LCM)
2. (Process) Validation
3. Process improvements
4. Standards and new technology deployment

Essential Job Duties and Responsibilities

Contribute to LCM/New Technology Introduction for the Site
Lead and/or support Life Cycle Management projects
Lead and/or support introduction of new technologies and digitalization projects
Act as Subject Matter Expert in USP and/or DSP for commercial manufacturing of pharmaceutical proteins and vaccines
Define (process) validation strategies.
Write and review (process) validation protocols and reports
Responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines and meet the quality requirements
Ensure integration of the global standards into local production processes
Act as primary interface between the Leiden site Operations, Quality, BTDS departments and the MSAT organization
Capable of leading and supporting complex investigations, facilitation of risk assessments
Act as SME during internal and external audits and inspections
Represent Leiden MSAT in global project teams.

Job Description
We have a vacancy for a (Sr Associate) Scientist TechTransfer / Life Cycle Management (LCM) to work at Johnson & Johnson Innovative Medicine, at Leiden site Manufacturing Science and Technology (MSAT).
MSAT manages the process technology platform strategy for the production of biotherapeutics and vaccines in Leiden. They are responsible for Validation and Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of their commercial production processes.
The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
The (Sr Associate) Scientist is a member of the Manufacturing Science and Technology (MSAT) Team with the dedicated focus on:
1. New Product Introduction (NPI) / Life Cycle Management (LCM)
2. (Process) Validation
3. Process improvements
4. Standards and new technology deployment
...

Essential Job Duties and Responsibilities

Contribute to LCM/New Technology Introduction for the Site
Lead and/or support Life Cycle Management projects
Lead and/or support introduction of new technologies and digitalization projects
Act as Subject Matter Expert in USP and/or DSP for commercial manufacturing of pharmaceutical proteins and vaccines
Define (process) validation strategies.
Write and review (process) validation protocols and reports
Responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines and meet the quality requirements
Ensure integration of the global standards into local production processes
Act as primary interface between the Leiden site Operations, Quality, BTDS departments and the MSAT organization
Capable of leading and supporting complex investigations, facilitation of risk assessments
Act as SME during internal and external audits and inspections
Represent Leiden MSAT in global project teams.

experience
7
skills
Job requirements
- A minimum of 7 years of relevant experience and BS degree or equivalent OR 4+ years with advanced degree MS/MBA/Ph.D. or equivalent in Life Sciences, Biotechnology, Biochemistry, Manufacturing Science and Technology
- Excellent knowledge of and experience in a scientific or technical core area. Overall knowledge of multiple technical and business disciplines.
- Experience with technical transfer
- Experience with Life Cycle Management (LCM)
- Ability to deliver local as well as regional small projects, global project work streams or departmental programs successfully under limited supervision. Selects applicable engineering/scientific tactics. Manages multiple moderate size projects.
- Experienced in coaching and training others
- Supports in defining department, project and/or program goals and tactics. Defines objectives to achieve targets on a team and/or individual level.
- Troubleshoots more complex problems and suggests effective resolutions.
- Provides direct input to budget and resource planning.
qualifications
HBO,WO

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sr associate scientist | scientist techtransfer and life cycle management | yacht life sciences|.

job details

experience

skills

qualifications

the application process.

apply with randstad.

we'll give you a call.

getting you registered.

compliance check.

reference and background check.

the perfect job for you.

the interview.

start your new job.

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