Pioneering generative biology to create breakthrough therapeutics.

Industry: Biotechnology Research
Company Size: 201-500 employees

Generate:Biomedicines

Savvy Admin PROD

**The Role:**

We are seeking a Principal Scientist, DS Process Development & Manufacturing, to join our growing Drug Substance group at Generate:Biomedicines. This role will support monoclonal antibody (mAb) drug substance development with a strong MS&T focus, bridging process development, scale-up, tech transfer, and GMP manufacturing execution. The position offers broad exposure across upstream and downstream operations, CDMO management, and quality systems.

**Here's how you will contribute:**

- Support Drug Substance process development and manufacturing activities (e.g., upstream expression, purification, UF/DF, viral clearance)

- Design and execute scale-up, process characterization, and PPQ-enabling studies

- Own tech transfer and support GMP campaigns at CDMO (person-in-plant support as needed)

- Review and/or author GMP documentation including batch records, change controls, deviations and CAPAs

- Provide technical leadership for GMP manufacturing, including troubleshooting and data-driven decision making

- Partner cross-functionally across CMC, QA, Regulatory, and Supply Chain to drive program execution

- Drive continuous process improvement and process robustness initiatives

- Leverage AI-driven tools for knowledge management and data analysis to enable efficient and scalable CMC workflows

**The Ideal Candidate will have:**

- PhD or MS in Chemical Engineering, Biochemistry, or related field with relevant industry experience in biologics manufacturing

- 5–8 years of industry experience in Drug Substance process development and/or GMP manufacturing in a biotech/pharma setting

- Strong attention to detail with the ability to analyze complex technical data

- Excellent communication and strong technical writing skills

- Experience working with CDMOs, supporting tech transfer, and regulatory submissions

- Hands-on experience with GMP documentation (eg: executed Batch Records) and quality systems (deviations, change control, CAPA)

- Demonstrated ability to lead complex technical programs and collaborate effectively in cross-functional teams.

- Familiarity of regulatory issues pertaining to the manufacture of biologics, process validation, QbD principles and industry trends

**Nice to Have (Optional)**

- Experience supporting BLA/IND submissions.

- Exposure to accelerated development environments for early to late-stage program transitions

**Location: **This role is based out of Somerville, MA with flexibility for hybrid work (1-2 days a week in the office).

**Why Join Us?**

This is an opportunity to contribute to the development of innovative biologics at a company transforming medicine through Generative Biology™. At Generate Biomedicines, you’ll work closely with cross-functional teams and external partners to support the delivery of high-quality Drug Substance for clinical programs. You’ll gain or broaden your exposure to late-stage CMC activities, collaborate with leading CDMOs, and play a key role in ensuring robust documentation and data integrity for products that matter to patients.

**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

$160,000—$224,000 USD

Principal Scientist, Drug Substance Process Development & Manufacturing

**The Role:**

Generate Biomedicines is seeking a Research Associate II/Senior Research Associate to join our CryoEM Group in generating large-scale protein structural datasets. This role offers the opportunity to work at the intersection of protein biochemistry and cutting-edge structural biology, contributing to our mission of accelerating drug discovery through advanced imaging technologies.

**Here's how you will contribute:**

- Perform protein purification, complexation, vitrification, and clipping, ensuring high-quality sample preparation for CryoEM.

- Load and operate CryoEM microscopes, executing data collection with automated workflows.

- Collaborate with multidisciplinary teams to support high-throughput protein structure determination.

- Follow standard operating procedures (SOPs) and contribute to process optimization.

- Document experimental data and report findings in internal databases.

- Interpret and troubleshoot experimental data, contributing to planning and prioritization of concurrent CryoEM experiments.

- Apply and refine data analysis methods; determine reliability of results and communicate findings in presentations or team meetings.

- Contribute to process optimization and implementation of new protocols.

**The Ideal Candidate will have:**

- MSc in Biochemistry, Structural Biology, Biophysics, Molecular Biology, Chemistry, or a related field and 0-2+ years of experience, or a BSc in Biochemistry, Structural Biology, Biophysics, Molecular Biology, Chemistry, or a related field with 2-4+ years of related experience.

- Hands-on experience in basic wet lab techniques, including pipetting, buffer preparation, and protein purification.

- Strong understanding of protein chemistry concepts, such as molarity, protein concentration, and buffer formulation.

- Ability to work in a fast-paced, collaborative research environment.

- Strong attention to detail and ability to troubleshoot technical issues.

**Preferred Additional Skills**

- Familiarity with structural biology techniques and CryoEM sample preparation.

- Prior exposure to CryoEM workflows or microscope operation with SerialEM.

**Who Will Love This Job:**

- You’re excited to learn fast and build deep expertise in CryoEM and structural biology—this role offers hands-on training with advanced instrumentation, real ownership of experiments, and the chance to grow your technical skillset alongside experienced scientists.

**Additional Information**

On-site position at our Andover, MA CryoEM lab

**Location: **Andover, MA (On-site, 5 days/week)

**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: $85,000 USD - $111,000 USD

Research Associate II/ Senior Research Associate

**About Generate:Biomedicines**

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

**The Role:**

We are seeking an experienced and pragmatic Senior Software Engineer to build and evolve the platform that powers machine learning at Generate. You will develop reliable, scalable, and observable systems that enable efficient model training, evaluation, and deployment for protein design. You will work closely with ML researchers, data scientists, and infrastructure engineers to translate research workflows into production-grade systems. This role requires 3 or more days/week onsite in our Somerville, MA location.

**Here's how you will contribute:**

- Build, maintain, and scale distributed ETL pipelines to integrate proprietary and public datasets into ML model training

- Design and deliver core services for model training, evaluation, and deployment across the ML platform.

- Collaborate with scientists, engineers, and product managers to define requirements and drive system improvements.

- Ensure reproducibility, observability, and cost efficiency across ML workflows.

- Contribute to the next generation of AI driven workflow orchestration, enabling researchers to run and evaluate models autonomously.

- Implement and evolve APIs and microservices with the cloud engineering team using AWS services and infrastructure as code to automate and standardize workflows.

**The Ideal Candidate will have:**

- 5 or more years of experience in software engineering, ideally building infrastructure or data systems for ML workloads.

- Practical experience designing, monitoring, and optimizing data pipelines and relational databases such as PostgreSQL or Redshift.

- Strong proficiency in Python and solid understanding of software design principles and patterns.

- Experience with distributed systems and containerized deployments on AWS using Docker, ECS, or Kubernetes.

- Familiarity with CI/CD, observability, and infrastructure as code tools.

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

$154,000—$216,000 USD

Senior Software Engineer I, ML Ops

**The Role:**

We are seeking a creative, motivated Computational Scientist to join our Model-Driven Design team at Generate:Biomedicines. You will join a talented and collaborative group of ML scientists, engineers, and wet-lab scientists dedicated to redefining how medicines are made. This role sits at the intersection of machine learning, structural biology, and therapeutic development, where you will stay at the leading edge of internal and external models for de novo protein design and systematically benchmark, integrate, and apply them within tightly integrated design–build–test–learn cycles to advance our therapeutic pipeline and impact patients' lives.

The ideal candidate combines deep structural intuition with a demonstrated ability to rapidly assess and apply protein design methods and metrics across diverse design problems, thinks in terms of reusable capabilities, benchmarks, and feedback loops across applications, and uses modern generative models and experimental readouts to guide iterative design cycles across modalities. You don't just run existing tools; you understand what's missing from current approaches and are driven to fill those gaps.

This role is based in our Somerville, MA office with flexibility for hybrid work.

**Here's how you will contribute:**

- Model application and optimization: develop, validate, and productionize de novo protein generation protocols and optimization techniques on our experimental platform, using measured data in-the-loop to iteratively refine models across modalities and therapeutic applications.

- Define and implement in silico metrics: design, interpret, and implement biophysical and functional metrics for evaluating generated designs, leveraging existing literature, adapting known metrics to new contexts, and performing original research to benchmark and deploy new scoring approaches.

- Benchmark foundation models and guide their application: rigorously evaluate new models and tools and provide quantitative conclusions on where they are best applied to generate new therapeutics, including designing systematic internal benchmarks and discovering how to expand model capabilities to prosecute new therapeutic targets in novel ways and to maximize reuse across targets and programs.

- Propose new therapeutic strategies: identify and implement solutions to create new therapeutics through mechanisms of action unlocked by de novo tools and modalities.

- Partner cross-functionally to drive therapeutic development: work closely with experimental colleagues, biologists, and clinical scientists to define design objectives, interpret experimental readouts, and guide iterative design-build-test-learn cycles that advance programs.

- Advance the state of the art: push forward sequence–structure–function understanding with a focus on reusable platform capabilities and model-informed feedback loops.

- Integrate agentic tools into workflows: leverage agentic AI tools to rapidly iterate on models, benchmarks, scores, critics, and other analysis tools, accelerating the pace of discovery.

- Build production-quality tools: develop robust, production-ready code in a collaborative team setting and present scientific progress in regular research meetings.

**What Success Looks Like**

- First 3 months: You have familiarized yourself with the proprietary Generate platform and either completed a first-pass design for a therapeutic program or built and applied your first internal tool or benchmark.

- By 6 months: You are fully fluent in the Generate stack. You have taken ownership of building or extending a segment of the platform applied to protein design, including designing or maintaining key benchmarks or metrics, or you are contributing materially to an active therapeutic program, driving design decisions with increasing independence.

- By 12 months: Given strategic direction, you operate with full autonomy scoping, building, and deploying new tools and methods that advance our protein design capabilities and therapeutic pipeline and strengthen our continuously learning, model-informed design platform.

**The Ideal Candidate will have:**

- PhD in Computational Biology, Biophysics, Computer Science, or a related field, with demonstrated experience in protein design applications.

- 0–2 years of experience applying computational and/or ML methods to protein design, modeling, or prediction.

- Hands-on experience with machine learning and generative modeling for protein design, including familiarity with modern methods such as RFDiffusion, ProteinMPNN, BindCraft, BoltzDesign, or equivalent approaches and how to deploy or evaluate them in practice.

- Strong structural intuition and understanding of protein biophysics with the ability to quickly assess and adapt design methods and metrics to new problems.

- Familiarity with protein therapeutic modalities such as antibodies, mini-proteins, VHHs, peptides, or enzymes, and an eagerness to deepen expertise across these within de novo design workflows.

- Proficiency in Python and scientific computing; comfort working in a production codebase.

- Experience designing, running, or interpreting benchmarks for computational or generative methods and drawing quantitative conclusions about model applicability and limitations.

**Strongly Preferred**

- Experience designing, executing, and interpreting experiments and experimental data (e.g., binding assays, stability measurements, structural characterization) and using those readouts to inform computational design iterations.

- Familiarity with agentic AI tools and their integration into scientific workflows.

- Exposure to structure-based design techniques and computational tools for modeling protein-protein interactions.

- Track record of translating research ideas into working software or reusable platform components used across multiple projects or applications.

**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

$154,000—$216,000 USD

Scientist I / Scientist II, Computational Protein Generation

**The Role:**

We are seeking a creative, motivated Computational Scientist to join our Model-Driven Design team at Generate:Biomedicines. You will join a talented and collaborative group of ML scientists, engineers, and wet-lab scientists dedicated to redefining how medicines are made. This role sits at the intersection of machine learning, structural biology, and therapeutic development, where you will stay at the leading edge of internal and external models for de novo protein design and systematically benchmark, integrate, and apply them within tightly integrated design–build–test–learn cycles to advance our therapeutic pipeline and impact patients' lives.

The ideal candidate combines deep structural intuition with a demonstrated ability to rapidly assess and apply protein design methods and metrics across diverse design problems, thinks in terms of reusable capabilities, benchmarks, and feedback loops across applications, and uses modern generative models and experimental readouts to guide iterative design cycles across modalities. You don't just run existing tools; you understand what's missing from current approaches and are driven to fill those gaps.

This role is based in our Somerville, MA office with flexibility for hybrid work.

**Here's how you will contribute:**

- Model application and optimization: develop, validate, and productionize de novo protein generation protocols and optimization techniques on our experimental platform, using measured data in-the-loop to iteratively refine models across modalities and therapeutic applications.

- Define and implement in silico metrics: design, interpret, and implement biophysical and functional metrics for evaluating generated designs, leveraging existing literature, adapting known metrics to new contexts, and performing original research to benchmark and deploy new scoring approaches.

- Benchmark foundation models and guide their application: rigorously evaluate new models and tools and provide quantitative conclusions on where they are best applied to generate new therapeutics, including designing systematic internal benchmarks and discovering how to expand model capabilities to prosecute new therapeutic targets in novel ways and to maximize reuse across targets and programs.

- Propose new therapeutic strategies: identify and implement solutions to create new therapeutics through mechanisms of action unlocked by de novo tools and modalities.

- Partner cross-functionally to drive therapeutic development: work closely with experimental colleagues, biologists, and clinical scientists to define design objectives, interpret experimental readouts, and guide iterative design-build-test-learn cycles that advance programs.

- Advance the state of the art: push forward sequence–structure–function understanding with a focus on reusable platform capabilities and model-informed feedback loops.

- Integrate agentic tools into workflows: leverage agentic AI tools to rapidly iterate on models, benchmarks, scores, critics, and other analysis tools, accelerating the pace of discovery.

- Build production-quality tools: develop robust, production-ready code in a collaborative team setting and present scientific progress in regular research meetings.

**What Success Looks Like**

- First 3 months: You have familiarized yourself with the proprietary Generate platform and either completed a first-pass design for a therapeutic program or built and applied your first internal tool or benchmark.

- By 6 months: You are fully fluent in the Generate stack. You have taken ownership of building or extending a segment of the platform applied to protein design, including designing or maintaining key benchmarks or metrics, or you are contributing materially to an active therapeutic program, driving design decisions with increasing independence.

- By 12 months: Given strategic direction, you operate with full autonomy scoping, building, and deploying new tools and methods that advance our protein design capabilities and therapeutic pipeline and strengthen our continuously learning, model-informed design platform.

**The Ideal Candidate will have:**

- PhD in Computational Biology, Biophysics, Computer Science, or a related field, with demonstrated experience in protein design applications.

- 0–2 years of experience applying computational and/or ML methods to protein design, modeling, or prediction.

- Hands-on experience with machine learning and generative modeling for protein design, including familiarity with modern methods such as RFDiffusion, ProteinMPNN, BindCraft, BoltzDesign, or equivalent approaches and how to deploy or evaluate them in practice.

- Strong structural intuition and understanding of protein biophysics with the ability to quickly assess and adapt design methods and metrics to new problems.

- Familiarity with protein therapeutic modalities such as antibodies, mini-proteins, VHHs, peptides, or enzymes, and an eagerness to deepen expertise across these within de novo design workflows.

- Proficiency in Python and scientific computing; comfort working in a production codebase.

- Experience designing, running, or interpreting benchmarks for computational or generative methods and drawing quantitative conclusions about model applicability and limitations.

**Strongly Preferred**

- Experience designing, executing, and interpreting experiments and experimental data (e.g., binding assays, stability measurements, structural characterization) and using those readouts to inform computational design iterations.

- Familiarity with agentic AI tools and their integration into scientific workflows.

- Exposure to structure-based design techniques and computational tools for modeling protein-protein interactions.

- Track record of translating research ideas into working software or reusable platform components used across multiple projects or applications.

**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: $140,000 USD - $200,000 USD

**The Role:**

The Senior Director, GCP & GVP will lead clinical quality and pharmacovigilance strategy across development-stage programs. This role ensures global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) compliance, provides guidance on clinical trial operations and safety reporting, and fosters a culture of quality, compliance, and patient safety. The Senior Director drives proactive risk identification and mitigation across the clinical development and pharmacovigilance lifecycle, ensuring inspection readiness and effective regulatory engagement.

This leader will partner cross-functionally to embed quality and safety considerations in clinical planning and will oversee a small, high-performing team of quality and pharmacovigilance professionals.

**Here's how you will contribute:**

- Lead GCP and GVP quality strategy and execution across clinical programs, ensuring compliance with FDA, EMA, and other global regulations.

- Maintain a phase-appropriate Quality Management System (QMS) for clinical and pharmacovigilance activities, including SOPs, training, document control, and vendor oversight.

- Oversee clinical quality and pharmacovigilance activities: site/vendor audits, deviation management, CAPAs, and safety reporting compliance.

- Serve as the primary contact for internal teams and CROs/vendors on clinical quality and safety matters.

- Support EU clinical compliance and collaborate with the Qualified Person (QP) on European clinical supply certification and release.

- Drive inspection readiness and support regulatory inspections and submissions (IND, CTA, BLA, MAA).

- Develop and monitor key quality and safety metrics to identify risks, ensure patient safety, and support continuous improvement.

- Lead, mentor, and develop a small team of GCP/GVP professionals.

- Partner with Regulatory Affairs to align quality and safety with regulatory strategy.

**Leadership Responsibilities**

- Set high standards for performance and accountability, ensuring clarity of expectations and outcomes.

- Recruit, develop, and retain diverse, high-performing team members.

- Foster transparent, courageous communication and cross-functional collaboration.

- Encourage adaptability and calculated risk-taking, modeling resilience through change.

**The Ideal Candidate will have:**

- BS or advanced degree in biology, chemistry, life sciences, or related field.

- 10+ years in biotech/pharma, with 6+ years in clinical quality and pharmacovigilance leadership.

- Strong knowledge of GCP, GVP, and global regulatory expectations, including EU regulations.

- Experience supporting both early- and late-stage development programs.

- Demonstrated success with inspection readiness and direct interactions with health authorities.

- Strong communication, collaboration, and leadership skills in a fast-paced, high-growth environment.

**Nice to Have**

- Prior experience with regulatory submissions.

- Proven ability to influence cross-functional stakeholders in an outsourced model.

**Location: ** This role will be based out of our headquarters in Somerville, MA. Open to hybrid work arrangement (in office 2-3 days/week)

**Why Join Us**

This is a unique opportunity to shape and advance a mission-critical function in a rapidly scaling, innovative biotech. You will directly impact the integrity of our clinical programs and contribute to the development of breakthrough medicines that redefine what’s possible in biotherapeutics.

**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 — $315,000 USD

Senior Director, GCP & GVP Quality

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