Validation Project Manager
- Recruiter
- Spring Technology
- Location
-
London
South East EnglandUnited Kingdom
- Salary
- Competitive
- Posted
- 14 Oct 2021
- Closes
- 22 Oct 2021
- Job Title
- Project Manager
- Category
- Scientific and Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
We have an exciting opportunity for a Validation Project Manager. The Contractor will be responsible for leading Process Validation and Life Cycle Management. The role will also be supporting Technology Transfer projects, Manufacturing investigations, Health Authority Inspections, and submissions.
Experience
* Strong scientific background including experience of Biopharmaceutical/Gene Therapy (ATMP) manufacturing processes.
* Experience on root cause problem solving and process optimization skills.
* Working across organizational boundaries through partnering, collaboration, influencing and negotiation.
* Excellent team player with strong customer focus.
Prinicipal responsabilities
* Leading the implementation and execution of process validations including reporting, product life–cycle improvements and technical transfer projects in compliance with internal corporate and global regulatory expectations.
* Supporting Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations including support on related aseptic process manufacturing activities e.g. sanitization, sterilization and aseptic simulation process development.
* Supporting "process fit to plant" during early and late stages of development to provide guidance to both development and manufacturing teams.
* Supporting "person in plant" by providing support during manufacturing campaigns for new products or during process validation campaigns.
* Providing expertise to Tech Transfer team on manufacturing facility design and capabilities, scale–up considerations and GMP operations.
* Support of complex manufacturing investigations, in particular event, deviations and CAPA by facilitating risk assessments to help meet product release specifications and timelines.
* Experience in quality systems, such as change controls, investigations and root cause analysis, risk management and/or control strategy.
* Partnering with Project Teams to provide input, review and approval support for BLA submissions.
* Participating in cross–functional project teams.
* Interpreting project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
* Fostering a culture of Lean and Continuous improvement within the department and with internal and external partners.
knowledge, skills, abilities and experience required)
* A minimum of a Bachelor's degree in Biology, Pharmacy, Engineering or related scientific field is required, advanced degree is preferred.
* 8+ years' experience within a regulated biologics or pharma industry, preferred gene therapy experience.
* Biological commercial manufacturing experience, either cell culture and/or purification and/or fill finish processes and strong process validation knowledge, in gene therapy programs is a plus.
* Good knowledge of EHSS and GMP requirements.
* Excellent communication, skills, both oral and written.
* Relationship building, partnering and influencing in a matrix organization is required.
* Capable of planning and leading experiments or projects steps with some supervision.
* Ability to work well in a team environment, strong collaboration skills and flexibility.
* Excellent interpersonal skills with the ability to adapt to rapid changes in project priorities and requirements.
* Acute attention to detail
* A focus on patients and customers at all time
Spring acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Spring Group UK is an Equal Opportunities Employer.
By applying for this role your details will be submitted to Spring. Our Candidate Privacy Information Statement explaining how we will use your information is available on our website.
Experience
* Strong scientific background including experience of Biopharmaceutical/Gene Therapy (ATMP) manufacturing processes.
* Experience on root cause problem solving and process optimization skills.
* Working across organizational boundaries through partnering, collaboration, influencing and negotiation.
* Excellent team player with strong customer focus.
Prinicipal responsabilities
* Leading the implementation and execution of process validations including reporting, product life–cycle improvements and technical transfer projects in compliance with internal corporate and global regulatory expectations.
* Supporting Technical Transfer activities through generation of protocols/reports, technical writing, execution of laboratory scale studies and participation in manufacturing operations including support on related aseptic process manufacturing activities e.g. sanitization, sterilization and aseptic simulation process development.
* Supporting "process fit to plant" during early and late stages of development to provide guidance to both development and manufacturing teams.
* Supporting "person in plant" by providing support during manufacturing campaigns for new products or during process validation campaigns.
* Providing expertise to Tech Transfer team on manufacturing facility design and capabilities, scale–up considerations and GMP operations.
* Support of complex manufacturing investigations, in particular event, deviations and CAPA by facilitating risk assessments to help meet product release specifications and timelines.
* Experience in quality systems, such as change controls, investigations and root cause analysis, risk management and/or control strategy.
* Partnering with Project Teams to provide input, review and approval support for BLA submissions.
* Participating in cross–functional project teams.
* Interpreting project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
* Fostering a culture of Lean and Continuous improvement within the department and with internal and external partners.
knowledge, skills, abilities and experience required)
* A minimum of a Bachelor's degree in Biology, Pharmacy, Engineering or related scientific field is required, advanced degree is preferred.
* 8+ years' experience within a regulated biologics or pharma industry, preferred gene therapy experience.
* Biological commercial manufacturing experience, either cell culture and/or purification and/or fill finish processes and strong process validation knowledge, in gene therapy programs is a plus.
* Good knowledge of EHSS and GMP requirements.
* Excellent communication, skills, both oral and written.
* Relationship building, partnering and influencing in a matrix organization is required.
* Capable of planning and leading experiments or projects steps with some supervision.
* Ability to work well in a team environment, strong collaboration skills and flexibility.
* Excellent interpersonal skills with the ability to adapt to rapid changes in project priorities and requirements.
* Acute attention to detail
* A focus on patients and customers at all time
Spring acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Spring Group UK is an Equal Opportunities Employer.
By applying for this role your details will be submitted to Spring. Our Candidate Privacy Information Statement explaining how we will use your information is available on our website.