Job Description
Reporting to the Senior Director, CMC Quality, you will provide expert advice to the Bicycle CMC team on the requirements for environmental monitoring, microbiology sampling and testing for aseptic drug products. You will work closely with the Analytical Sciences team and will be accountable for the review and approval of analytical and microbiological validation documents and process validation documents. You will be accountable for the review and approval of test methods specifications, stability documentation and CoAs. You will work closely with the Regulatory team to verify data for regulatory submissions.
* Provision of technical expertise and leadership in QC microbiology for aseptic products
* Provision of technical expertise and leadership in the design of stability protocols, validation protocols, sampling plans and test methods.
* Quality review and approval of stability documents, validation documents, sampling plans, material and drug product release specifications, CoAs and test methods documents provided by CDMOs.
* Using the eQMS to manage deviations, OOS investigations and change controls.
* Participate in the creation, review, revision and maintenance of Standard Operating Procedures (SOPs) and controlled documents for GxP activities.
* Work with functional leaders, CDMOs and Quality to set-up, maintain and improve QC KPIs.
* Ensure that the BicycleTx Pharmaceutical Quality System (PQS) is always inspection ready phase appropriate, and where gaps are identified ensure that action plans are in place to return to a compliant state.
* Manage the self-inspection and internal audit program for QC.
* Qualify GxP testing providers where necessary per Bicycle Supplier Qualification procedure (this may include some audit travel where applicable).
* QC review of CDMO provided analytical and microbiological GMP data and data to be used in regulatory submissions.
* Management of reference materials
Qualifications
* Experienced QC microbiology requirements for aseptic manufacturing
* Experienced in process validation
* Experienced in method validation and verification
* Knowledge of phase appropriate GMP release of materials and product
* Strong background in GMP Quality and Compliance with a strong understanding of both FDA and EU regulations in CMC development settings
* Highly collaborative, strong relationship building skills with a high level of integrity.
* First class communication and influencing skills with the ability to manage multiple stakeholders.
* Resilient and able to work effectively in a demanding and fast-paced environment.
Additional Information
* State-of-the-art campus environment with on campus restaurant and Montessori nursery
* Flexible working environment
* Competitive reward including annual company bonus
* Employee recognition schemes
* 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually
* Employer contribution to pension (employee does not have to contribute)
* Life assurance cover 4x basic salary
* Private Medical Insurance, including optical and dental cover.
* Group income protection
* Employee assistance program
* Health Cash Plan
* Access to company subsidized gym membership.
* Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
* Cycle to work scheme
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.