Quality Control and Validation Manager

Company Description

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle Radio Conjugates (BRC) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle technology to develop therapies for diseases beyond oncology.

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA USA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination.
• We are One Team. We only succeed when we work together.

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.