Scientist - Injectable Drug Product Process Development

Social network you want to login/join with:

Scientist - Injectable Drug Product Process Development, Slough

Client: Next-Link

Location: Slough, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: a384c62637cc

Job Views: 3

Posted: 18.04.2025

Expiry Date: 02.06.2025

Job Description:

Job Description
Primary Purpose / Regulatory Responsibilities:

1. Technical expert in the establishment of robust, fit for purpose injectable drug product manufacturing processes from toxicology studies or first in human until BLA approval.
2. Define and select drug product manufacturing processes and parameters for clinical manufacture.
3. Cooperate with a wide range of internal and external stakeholders, including contract manufacturing organizations, as part of a project team.
4. Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (e.g., filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc.)
5. Capture and analyse critical manufacturing process data for process understanding and process characterization.
6. Perform process risk assessments.
7. Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products.
8. Define the investigational medicine product preparation process in clinical trials.
9. Provide support to ensure timely manufacture of stability and clinical DP batches.
10. Provide support to process performance qualification/validation.
11. Ensure products are manufactured in accordance with our quality system, cGMP and latest regulatory requirements.
12. Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities.
13. Provide support in investigations of deviations and complaints related to DP quality.
14. Support knowledge transfer from late phase development to commercial for validated DP processes.
15. Contribute to develop the ways of working in the department.

Requirements

1. Minimum 2-3 years’ experience in liquid drug product development and/or manufacturing within the pharmaceutical industry is required.
2. Experience within the bio pharmaceutical industry is an advantage.
3. Knowledge and technical experience in liquid drug product development and cGMP manufacturing under aseptic conditions (such as vial, cartridge and pre-filled syringe filling) is an advantage.
4. Technical knowledge of sterile DP development covering DP components, process transfer, scale-up and optimization is an advantage.

Education and Certifications:
- Bachelor's Degree - Other (Specify): Bachelor (Belgium) or experience Equivalent
- Certification (Specify): Veeva CRM certification (MUST): system admin gold configuration level
- Salesforce CRM (Nice to have)
- Veeva Vault (preferred)

Experience:
- CRM system admin experience (technical expertise and functional expertise)
- Project management skills
- Business analyses
- Can help in shaping our CRM strategy
- At least 10 years in Pharma
- At least 10 years in CRM

Skills:
1) Organized & well structured
2) Can do both Project manager & Business analyst
3) Stakeholder management (focus on priorities, scoping where needed)
4) IT context (be able to manage architecture, integrations, Dev-Acc-Prod, UAT & IT standard processes)