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. Generate 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 was founded in 2018 by Flagship Pioneering and has received over $420 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with over 250 employees.

The Role:

Generate is seeking a highly experienced and innovative Director Drug Product & Device Development to join our growing team. This candidate will work closely with our machine-learning and data sciences to revolutionize drug development and enhance patient lives through innovative dosage forms and drug delivery systems. This role is responsible for early-stage clinical formulation development, developing several enabling formulations and drug delivery systems for use in clinical studies and future validation of drug product manufacturing processes. This role will report to the Sr. Director of Development and play a key role in advancing the CMC strategy for Generate's pipeline.

Here's how you will contribute:

• From pre-clinical through commercialization, this role is accountable for product definition, formulation development, aseptic process development and characterization, container science, process scale up, and technology transfer through validation
• Design, execute, and lead pre-clinical and clinical formulation development efforts and associated manufacturing in the development of solid/liquid oral dosage forms for use in clinical studies and potential commercialization
• Investigate formulation development approaches in early stages and understand processes to facilitate fast entry into humans
• Design phase appropriate formulations at different stage of development (preclinical to clinical phase III) and commercialization
• Support formulation and manufacturing work for current and future drug products at CDMOs; needs to work effectively by providing technical oversight to ensure project timelines and technical deliverables are met
• Lead technical interaction with drug product and device partners to develop, manufacture, and package products
• Responsible for troubleshooting and innovating solutions for challenging formulations for higher concentration, larger volumes and long-acting injectables
• Lead combination device development focused on enabling device design for challenging applications for optimizing delivery; patient-centric interfaces for self-administration and drug-device development iteration cycles to minimize risks for clinical outcomes
• Interface closely with Clinical Operations and Early Development organizations to execute and support clinical in-use characterization studies and related documentation
• Design and carry out physical characterization/physical pharmaceutics/materials science studies required for the assessment of developability of an API into a formulated product that meets the target product profile.
• Serve as the scientific leader in drug product formulation, develop strategic development plans in alignment with our clinical trial plans and company goals
• Work in close collaboration with the Project and CMC teams and related functions, including discovery, non-clinical development, process development, analytical development, Quality, clinical supply chain, and Regulator

The Ideal Candidate will have:

• Ph.D. in chemistry, biochemistry, and pharmaceutical sciences, or related field with 12 years of relevant experience in pharmaceutical development and drug product manufacturing or M.S. in chemistry, biochemistry, pharmaceutical sciences, or related field with 16 years of relevant experience in pharmaceutical development and drug product manufacturing or Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 18 years relevant industry experience
• Expertise in protein pre-formulation and formulation development, lyophilization, and analytical and biophysical characterization skills
• The candidate must have sound understanding of material properties to develop a robust formulation in support of clinical trials and commercial, along with pre-formulation, reformulation, and drug delivery experience
• Required 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
• Experienced and demonstrated track record in biopharmaceutical development including biologics formulation development drug product development, drug product process characterization, QbD, control strategy, and process validation
• 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
• Display a strong understanding of early and mid-stage drug product development and transfer needs of commercial development
• Excellent communication, influencing skills and ability to deal with ambiguity and change

Who Will Love This Job

• A go-getter to loves taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
• Someone who operates effectively, even when things are not certain, or the way forward is not clear
• A partner who gains the confidence and trust of others through honesty, integrity, and authenticity
• A technical subject matter expert who relies on a mixture of analysis, wisdom, experience, and judgement when making recommendations
• Someone who enjoys working in a fast-paced, team environment where ideas and information are shared to secure the best outcome for the company and our patients

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 Generate Biomedicines'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 Generate will not owe any referral or other fees with respect thereto.

#LI-RT1