Manager/Senior Manager, Batch Record Review & Documentation

Position Overview

Bicara Therapeutics is seeking a Manager/Senior Manager of Batch Review & Documentation to provide guidance, support and oversight of GxP activities across manufacturing, non-clinical, clinical and commercial programs. This role ensures compliance with internal SOPs, regulatory requirements (FDA, ICH, country-specific) and industry standards.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

• Author and/or review SOPs to ensure consistency, compliance and effective implementation.
• Advise departments on regulatory interpretation, risk management, and best practices.
• Oversee resolution of compliance issues, including CAPA planning and approval.
• Support clinical trial compliance and drug safety practice reviews.
• Conduct and support internal and external GxP audits and inspections.
• Review GxP related documents and provide staff training guidance.
• Partner with department heads to address training needs from regulatory changes, audit findings, or trends.
• Collaborate cross-functionally to achieve company objectives.
• Support inspection readiness and assist during regulatory inspections.
• Administer EQMS, including use access, training and controlled documentation.
• Other duties based on business needs.

Qualifications

• BS in a life science field required.
• Strong knowledge of GMP and ICH requirements.
• 5+ years of direct GxP pharmaceutical/biotechnology experience.
• 3+ years of experience with batch record review.
• Experience communicating with and managing external vendors.
• Excellent written and oral communications skills.
• The ability to manage multiple priorities in a dynamic, fast-paced environment.
• Excellent interpersonal skills with foundational negotiation, influence, and conflict management abilities to ensure effective collaboration within and across departments.
• Organized, self-motivated, and effective in cross-functional teams.

Company Overview

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.