Senior/Principal Scientist – Formulation Sciences and Drug Product Manufacturing
Magenta Therapeutics is a clinical-stage biotechnology company developing therapeutics to reset the immune system to cure more patients with devastating and life-threatening diseases. This immune reset approach can be applied through stem cell transplant to multiple diseases, including autoimmune diseases, such as multiple sclerosis and systemic sclerosis; blood cancers, such as acute myeloid leukemia; and genetic diseases, such as sickle cell disease.
Magenta's comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective. Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact, and pursuing progress for the patients we seek to serve.
We are seeking a motivated and experienced formulation and drug product scientist to drive formulation development, drug product development and manufacturing activities across the portfolio. Our team is a place where the autonomy to chase an idea and drive innovative solutions are not just encouraged and supported but expected. If you are looking for a place where you can impact the actual strategy of your company while remaining close to the lab and the science, we would like to hear from you.
You are perfect for this role if you are engaged by and want to be responsible for:
- Formulation and drug product development strategy from research through commercialization
- Phase-appropriate formulation and drug product development studies for peptides, mAbs, bispecific antibodies, and other modalities to deliver program and corporate objectives
- Formulation and drug product process tech transfer to CMOs
- Evaluating and delivering fit-for-purpose GLP Tox, FIH, and commercial liquid or lyo formulations
- Leading and supporting departmental or cross-functional key initiatives to drive scientific and technical innovation and develop internal capabilities and expertise
- Parenteral drug product development, manufacturing, and associated CMC activities including late-stage and readiness for commercialization
- Ensuring that technically sound drug product processes are designed, developed, and scaled up, and transferred to manufacture of clinical supplies and commercialization
- Drug product control strategy, risk assessments, and studies including those related to particles, elemental impurities, L/E, and container closures
- Collaborating with the clinical, translational sciences, and pharmacology teams to support non-clinical and clinical studies and translating the TPP, clinical dosage, and other relevant input into formulation and drug product targets and specification justifications
We would be thrilled if you brought the following with you:
- PhD in pharmaceutical sciences or related discipline and at least 6 years of experience in biologics development
- Expertise in early- and late-stage biologics formulation development and drug product process development following QbD principles
- Experience with drug product tech transfer to CMOs
- Experience with liquid and lyo drug products for a variety of modalities including but not limited to peptides, monoclonal antibodies, bispecific antibodies, and ADCs
- Experience supporting pre-formulation and in-use stability studies in support of non-clinical studies is strongly preferred
- Solid understanding of the evolution of formulation and drug product development principles from IND-enabling studies through BLA, including FIH and commercial formulation and process development, risk assessments, process characterization, and PPQ
- Experience working with contract manufacturing organizations to complete formulation and drug product process tech transfer and scale-up for liquid and lyo products
- Experience with parenteral drug products, aseptic fill/finish, and associated microbiological safety-related considerations
- Experience with contributing formulation- and drug product-related content of regulatory submissions and familiarity with phase-appropriate requirements and ICH and other regulatory guidelines
- Experience with visible and sub-visible particle characterization and testing
- Experience with biophysical methods including CD, FTIR, DSC, AUC, light scattering, etc.
- Proven ability to deliver results independently while collaborating effectively within cross-functional teams
- Excellent analytical, communication, organizational and presentation skills
- Commitment to a high-performance, patient & people-first culture, where there is alignment around a common vision and individuals are supported in their growth path
Successful leaders and contributors within Magenta are:
- Driven. You will be focused on the achievement of Magenta's mission and major corporate goals.
- Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way
- Intuitive. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business
- Collaborative. You will have demonstrated the ability to achieve objectives across complex projects and organizational structures
- Process-oriented, yet flexible. You will appreciate and be able to create and drive process, while also recognizing when flexibility is needed.
- Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders
- Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company
- A role model for the company's cultural pillars; Courage Commitment & Excellence
At Magenta, we celebrate our differences. We value the power of a diverse array of folks who bring all of themselves to their work. We embrace cultural, cognitive, social, and professional diversity because we know the only way we're going to make new cures possible is by working together.