Principal Scientist, Drug Product Development

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 over $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 to expand the technical development group within technical operations by recruiting a talented and collaborative principal scientist, responsible for developing sterile injectable dosage forms for large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into sterile drug products.

This position provides the opportunity to develop AI-based, next generation biologic therapeutics while enabling a high degree of independence in daily work, opportunities for cross-functional learning, contribution to project direction and scope, and potential contribution to technical and regulatory documents in a well-funded biotech startup.

Here's how you will contribute:

• Be a seasoned biologics product developer responsible for designing and developing sterile products for injectables and ocular drug products.
• Support both early and late-stage development candidates that will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.
• Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small group of scientists during product development to ensure completion of key milestones and laboratory / regulatory documentation.
• Active strategic and technical leadership to influence program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.
• Outstanding communication skills and the ability to clearly articulate risks and trade-offs experienced within product development to appropriate governance venues and management
• Responsible for ideating, leading, and championing organizational strategic and innovation objectives aligned with organizational goals.
• Has subject matter expertise with process scale up, modeling, regulatory filings for commercialization and/or driving key capability evaluation/ build
• Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.
• Proven demonstration of leadership behaviors
• Be a change agent for continuous improvement of internal processes contextualizing the broader portfolio outside of their assigned programs.

The Ideal Candidate will have:

• Ph.D. with 8 years of industry experience, or a Master’s degree with at least 12 years in Chemical/Biomedical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.
• Strong track record in biologics product development, including multiple regulatory filings across modalities such as monoclonal antibodies, ADCs, fusion proteins, and combination products.
• Expertise in process development and characterization for biologic drug products, with a proven record of successful technology transfers to GMP manufacturing sites.
• Demonstrated external presence through scientific publications and/or patents.
• Experience designing and executing DOE studies to assess risks such as oxidation and light exposure in drug products.
• Strong knowledge of Quality by Design (QbD) principles and experience applying QbD tools in development.
• Familiarity with analytical methods and specifications for biologic drug products and formulation considerations for drug substances.
• Preferred experience in lyophilization and combination drug product development with a good understanding of the inter-relationship among formulation parameters, process parameters, device performance, product delivery and quality
• Experience developing and submitting regulatory filings for biologic combination products (e.g., IND, BLA, MAA), including response preparation for Health Authorities.
• Ability to support CMC and program teams as a subject matter expert, including technical due diligence and CRO/CMO assessment and management.
• Skilled in authoring, reviewing, and approving technical protocols, reports, and GMP/quality documentation.
• Strong understanding of current regulatory expectations and emerging technologies in drug product and combination product development.
• Collaborative mindset with the ability to work across cross-functional teams and disciplines.
• Strong problem-solving skills and ability to work independently in a fast-paced, startup environment.
• Effective communication skills; able to present complex data clearly to a range of audiences.
• Proactive and organized, with the ability to manage multiple tasks, timelines, and priorities.
• Proficient in Microsoft Office (Excel, Word, PowerPoint)
• Experience working with contract research organizations (CROs).

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.

COVID Safety:

Generate:Biomedicines enforces a mandatory vaccination policy for COVID-19. All employees must be fully vaccinated and have received a booster. The purpose of this policy is to safeguard the health of our employees, their families, and the community at large from infectious disease that may be reduced by vaccinations. The Company will make exceptions to this policy if required by applicable law and will consider requests for an exemption from this policy due to a medical reason, or because of a sincerely held religious belief, or any other exemptions that may be recognized by applicable.

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.