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Quality Control and Validation Manager, Cambridge
Client: Bicycle Therapeutics
Location: Cambridge, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 7117fb72e641
Job Views: 12
Posted: 26.04.2025
Expiry Date: 10.06.2025
Job Description:
Reporting to the Senior Director, CMC Quality, you will provide expert advice to the Bicycle CMC team on environmental monitoring, microbiology sampling, and testing for aseptic drug products. You will review and approve analytical and microbiological validation documents, process validation documents, test methods, specifications, stability documentation, and Certificates of Analysis (CoAs). Collaboration with the Regulatory team to verify data for submissions is also required.
* Provide technical expertise and leadership in QC microbiology for aseptic products.
* Design stability protocols, validation protocols, sampling plans, and test methods.
* Review and approve stability documents, validation documents, sampling plans, release specifications, CoAs, and test methods from CDMOs.
* Manage deviations, OOS investigations, and change controls using the eQMS system.
* Create, review, revise, and maintain SOPs and controlled documents for GxP activities.
* Work with leaders, CDMOs, and Quality teams to set up, maintain, and improve QC KPIs.
* Ensure the BicycleTx PQS is inspection-ready, addressing gaps as needed.
* Manage the QC self-inspection and internal audit program.
* Qualify GxP testing providers as per the Bicycle Supplier Qualification procedure, including audits if applicable.
* Review analytical and microbiological GMP data from CDMOs for regulatory submissions.
* Manage reference materials.
Qualifications:
* Experience in QC microbiology for aseptic manufacturing.
* Experience in process validation.
* Experience in method validation and verification.
* Knowledge of GMP release procedures for materials and products.
* Strong understanding of FDA and EU regulations in CMC development.
* Collaborative with excellent relationship-building skills and high integrity.
* Effective communication and stakeholder management skills.
* Resilient, adaptable, and capable of working in a fast-paced environment.
Additional Information:
* State-of-the-art campus with amenities including on-campus restaurant and Montessori nursery.
* Flexible working environment.
* Competitive rewards including annual bonus.
* Employee recognition schemes.
* 28 days annual leave plus bank holidays, with options to buy additional days.
* Employer contributes to pension; no employee contribution required.
* Life assurance (4x salary), private medical insurance, group income protection, employee assistance, health cash plan, subsidized gym membership, share options, cycle to work scheme.
Bicycle Therapeutics values diversity and inclusion. We consider all qualified applicants regardless of race, religion, gender, sexual orientation, age, disability, marital or veteran status.
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