--- title: 'Senior Director, GMP Quality at Generate Biomedicines' canonical: 'https://feeny.ai/job/senior-director-gmp-quality-generate-biomedicines-somerville-fc88949dnbya' type: 'job' last_seen: '2026-09-26' --- # Senior Director, GMP Quality at Generate Biomedicines - **Company:** Generate Biomedicines - **Location:** Somerville, MA - **Compensation:** $210k–$290k - **Posted:** 2026-09-18 - **Last confirmed live:** 2026-09-26 - **Apply:** https://generatebiomedicines.com/open-positions?gh_jid=4714150006 ## Job description The Role: The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and company requirements. This is a hands-on individual contributor leadership role that will partner closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company stakeholders to support programs from development through commercialization. This role will report to the Vice President, Head of Quality. Here's how you will contribute: - Establish and maintain a scalable, risk-based GxP Quality framework covering analytical testing, manufacturing, technology transfer, validation, product lifecycle management, and regulatory commitments. - Provide independent, phase-appropriate Quality oversight of CMC and analytical strategies, including control strategies, CQAs, CPPs, specifications, method development and validation, comparability, stability, reference standards, and lifecycle management. - Serve as an enterprise Quality leader and strategic advisor to Technical Operations, Regulatory Affairs, Supply Chain, executive leadership, and cross-functional teams on product quality, supply continuity, regulatory readiness, and business objectives. - Build a culture of quality, accountability, scientific rigor, collaboration, and proactive risk management across Generate and its external partners. - Lead Generate’s CMC Quality relationships with CDMOs, contract testing laboratories, and other technical partners, including qualification, quality agreements, governance, performance management, audits, and issue escalation. - Provide Quality oversight of outsourced development, manufacturing, testing, packaging, and storage activities, ensuring compliant and timely execution of clinical supply, GMP release, stability, validation, and lifecycle management activities. - Provide Quality leadership across technology transfer, scale-up, process characterization, manufacturing changes, comparability, continued process verification, and other product and process lifecycle activities. - Review and approve key GMP and regulatory documentation, and provide quality leadership for manufacturing campaigns, batch review and release, deviations, investigations, OOS/OOT results, CAPAs, change controls, product disposition, and other significant quality events. - Drive product quality risk management, audit and inspection readiness, data integrity, computerized systems compliance, and alignment with global regulatory expectations, cGMP requirements, quality agreements, and Generate standards. - Support global regulatory submissions and health authority interactions by developing and reviewing CMC/QC Quality content, assessing data and control strategies, and supporting responses to regulatory questions. - Establish and monitor Quality performance indicators, identify evolving regulations and industry pr Leadership Qualities: - Brings deep GMP, GLP, manufacturing, and regulatory expertise with sound judgment, business partnership, and strong people leadership. - Sets a clear Quality vision while remaining engaged in critical operational issues and making timely, well-reasoned decisions. - Identifies and prioritizes compliance and product risks, maintaining Quality’s objectivity and challenging decisions when patient safety, data integrity, or regulatory compliance may be compromised. - Provides practical, timely, and science-based guidance that enables development progress while protecting product quality, participant safety, data reliability, and regulatory integrity. - Builds trust and alignment across Technical Operations, Preclinical, Regulatory, Clinical, Supply Chain, and internal and external partners through credibility, listening, diplomacy, and consistency. - Creates a culture in which Quality is owned across the organization, while maintaining strong oversight of documentation, data integrity, systems, and remediation commitments. - Develops fit-for-purpose Quality systems that support growth without unnecessary complexity, using metrics, lessons learned, and root-cause thinking to strengthen processes and prevent recurrence. - Provides day-to-day leadership to Quality contractors and other team members; may assume broader people-management responsibilities as the organization grows The Ideal Candidate will have: - Bachelors degree in a relevant scientific discipline and 15+ years of biopharmaceutical industry experience - Extensive GxP quality leadership experience supporting biologics development, including GMP and GLP operations. - Strong understanding of quality systems, including deviations, investigations, CAPAs, change controls, OOS/OOT management, data integrity, and inspection readiness. - Experience providing quality oversight across preclinical, CMC, clinical manufacturing, quality control, supply chain, and product lifecycle activities. - Strong knowledge of biologic products regulations, process validation, method validation, stability, comparability, specifications, and control strategies. - Proven ability to establish phase-appropriate Quality strategies and scalable systems for early- and late-stage development programs. - Significant quality oversight experience working with CDMOs, CROs, contract testing laboratories, suppliers, and other external partners. - Experience leading audits, quality agreements, partner performance management, investigations, remediation, and risk mitigation. - Demonstrated success supporting regulatory submissions, health authority interactions, inspections, and responses to regulatory findings. - Experience partnering with Technical Operations, Preclinical, Regulatory, Clinical, Manufacturing, and Supply Chain teams. - Proven ability to build, mentor, develop and lead high performing Quality Teams - Excellent communication and influencing skills, with the ability to explain complex scientific, regulatory, and quality matters to executive leadership and external stakeholders. - A strategic, proactive, and hands-on leader who anticipates risk, makes sound decisions, and holds teams and partners accountable. - Commitment to patient safety, product quality, data integrity, compliance, and continuous improvement. ## Nice to Have - Involvement in pre-approval inspections, regulatory inspections, and commercialization readiness for biologics. - Exposure to highly outsourced or virtual biotechnology operating model. - Involved in implementing new quality technologies, electronic systems, automation, or data-driven quality tools - Global experience with health authorities, suppliers, and development or manufacturing partners. - Strategic Quality and GMP leadership for combination drug product development ## About Generate Biomedicines We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines. Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation. At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors. Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto. Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range $210,000—$290,000 USD ## About Generate Biomedicines ## Company Overview - **One-liner**: Generate Biomedicines is a clinical-stage generative biology company pioneering the use of machine learning to design and develop protein-based medicines on demand. - **Entity Type**: Public (ticker: GBIO) - **Headquarters**: Somerville, Massachusetts, USA (Boynton Yards and Andover locations) - **Founded**: 2018 - **Founders**: Gevorg Grigoryan, Daria Hazuda, and others ## Core Business - **Primary industry**: Biotechnology / Drug Discovery & Development - **Target customers**: B2B (pharmaceutical partners) and patients (via clinical programs) - **Mission statement**: "We don’t discover medicines—we design them," with a belief that speed is a moral obligation to patients. ## Products & Services - **[Generate Platform™]**: An integrated computational and biohardware innovation stack that uses generative biology to design proteins with defined biological intent. It can generate up to a billion designed variants per cycle with cycle times as fast as ~8 days. - **[GB-0895 (Anti-TSLP Antibody)]**: A next-generation anti-TSLP monoclonal antibody for severe asthma and COPD, currently in global Phase 3 trials. Designed for ultra-high affinity (106 fM binding, 20x improvement over tezepelumab) and an extended half-life (98 days, longest known among TSLP-targeting therapies), enabling twice-yearly subcutaneous dosing. - **[GB-5267 (MUC-16 Armored CAR-T)]**: A cell therapy candidate for metastatic ovarian cancer, expected to enter Phase 1 in 1H26. - **[GB-4362 (Free MMAE Toxin Neutralizer)]**: A first-in-class neutralizer designed for combination with MMAE-based antibody-drug conjugates (ADCs), with Phase 1 initiation in bladder cancer expected 1H26. ## Market Standing - **Valuation/Market Cap**: Not publicly disclosed; IPO in February 2026 raised net proceeds of approximately $370 million. - **Key Metric**: $221.5 million cash balance at YE 2025, plus ~$370 million from IPO (early 2026). - **Notable Investors/Partners**: Strategic collaborations with Amgen, Novartis, MD Anderson Cancer Center, and Roswell Park Comprehensive Cancer Center. - **Growth Signals**: 5 clinical-stage programs enabled by the platform; initiated global Phase 3 studies for GB-0895; operating out of 140k+ square feet of lab and office space; has studied millions of proteins and generated 42,000 proteins built and tested. ## Competitive Advantages - **Fully integrated computational-biohardware loop**: Machine learning drives generative design, which feeds directly into high-throughput experimentation (including proprietary CryoEM with four of the best microscopes in the world), and results continuously train the AI system — a "living feedback loop" that compounds over time. - **Multimodal platform**: Can generate candidates across antibodies, CAR-T, and other protein modalities from a single core technology, enabling a pipeline that covers both immunology and oncology. - **Record speed and scale**: Capable of generating up to a billion designed variants in ~8-day cycles, dramatically reducing the time and cost traditionally associated with drug discovery. - **First-mover in next-gen anti-TSLP**: First known next-generation anti-TSLP antibody to enter the clinic (GB-0895) with a differentiated half-life profile that could enable twice-yearly dosing, a significant competitive edge in a large market. ## Strategic Focus - **Clinical execution**: Advancing GB-0895 through global Phase 3 trials in severe asthma (with data in 2H27/1H28) and initiating late-stage development in COPD. - **Pipeline expansion**: Moving GB-5267 (CAR-T) and GB-4362 (ADC neutralizer) into Phase 1 in 2026, expanding the platform's therapeutic scope. - **Platform scaling**: Continuing to refine the generative biology engine to unlock new modalities and therapeutic areas, while deepening existing strategic collaborations with major pharma partners. - **Organizational growth**: Building out the team across computational, wet-lab, clinical, and operational functions to support the growing pipeline. ## Why Work Here - **Mission-driven**: The company is explicit that "speed is not just a competitive advantage—it’s a moral obligation." Employees are directly involved in designing drugs rather than discovering them, with a focus on getting treatments to patients faster. - **Interdisciplinary culture**: The company emphasizes true integration across machine learning, biological engineering, and medicine. As stated on their site, "We are a close-knit group of cross-disciplinary experts... each conversant in one another’s fields, working together to create a new one." - **Cutting-edge technology**: Access to unique computational and biohardware infrastructure, including "the four best CryoEM microscopes in the world" and a high-throughput experimental loop that powers AI training in real-time. - **Values-driven leadership**: Explicit leadership behaviors include "value the knowledge we gain more than the knowledge we have," "bring creativity, tenacity, and ingenuity to every challenge," and "hold oneself and others to an obligation to dissent." - **Hybrid/office policy**: Not explicitly stated, but the company operates large physical facilities in Somerville and Andover, MA, and offers free parking, monthly subway passes, or subsidized commuter rail passes, suggesting a significant on-site expectation. - **Comprehensive benefits**: Competitive pay, employee stock option plan, health/vision/dental insurance, long- and short-term disability, life insurance, EAP, retirement savings, paid parental/adoption/caregiver leave, free weekly lunch, and stocked kitchen. - **Growth trajectory**: As a newly public company with a cash-rich balance sheet and multiple catalysts over the next 12–24 months, the company offers significant career growth potential for those who want to be part of building a "transcendent company" that redefines an industry. ## Sources 1. [generatebiomedicines.com](https://generatebiomedicines.com/) 2. [generatebiomedicines.com/careers](https://generatebiomedicines.com/careers) 3. [generatebiomedicines.com/about-us](https://generatebiomedicines.com/about-us) 4. [investors.generatebiomedicines.com](https://investors.generatebiomedicines.com/) 5. [Non-Confidential Overview (April 2026)](https://investors.generatebiomedicines.com/wp-content/uploads/2026/04/Generate-Biomedicines-Non-Confidential-Overview_April-2026-1.pdf) ## Other roles at Generate Biomedicines - [Director, Wet Lab Engineering](https://feeny.ai/job/director-wet-lab-engineering-generate-biomedicines-somerville-ac89ba7e1ywd) — Somerville, MA - [Associate Director, Clinical Operations](https://feeny.ai/job/associate-director-clinical-operations-generate-biomedicines-remote-wv0n1zc42hm9) - [Senior Manager, Clinical Data Management](https://feeny.ai/job/senior-manager-clinical-data-management-generate-biomedicines-remote-t922kj0yrt6x) - [Director, Clinical Operations](https://feeny.ai/job/director-clinical-operations-generate-biomedicines-remote-s8tfcjh9tsm4) - [Senior Director, Protein Analytics & Biophysics](https://feeny.ai/job/senior-director-protein-analytics-biophysics-generate-biomedicines-somerville-svzx43cekjwx) — Somerville, MA - [Senior Director, Medical Monitor (Respiratory indications)](https://feeny.ai/job/senior-director-medical-monitor-respiratory-indications-generate-biomedicines-7fsgqef53wnk) - [Senior Scientist I, Biotherapeutic Production Technologies](https://feeny.ai/job/senior-scientist-i-biotherapeutic-production-technologies-generate-biomedicines-bv9g98d0ty9p) — Andover, MA - [Senior Director, Analytical Development](https://feeny.ai/job/senior-director-analytical-development-generate-biomedicines-somerville-zvvqdh5c10xe) — Somerville, MA - [Vice President, Head of Immunology and Inflammation Development](https://feeny.ai/job/vice-president-head-of-immunology-and-inflammation-development-generate-0rh42ghav49e) - [Director, Clinical Scientist (Respiratory indications)](https://feeny.ai/job/director-clinical-scientist-respiratory-indications-generate-biomedicines-remote-sfd31c7p5ean)