Scientist II, R&D Formulation Development

Lonza•Houston, TX

1d•Onsite

About The Position

Scientist II, R&D Formulation Development Location: This is an on-site position located in Pearland, TX The purpose of this role is to work as an essential part of a high performing team with the goal of designing and optimizing robust, stable formulations for viral vector products, with special emphasis given to AAV and lentiviral vectors for clinical and commercial cell and gene therapy applications. The successful candidate will serve as a subject matter expert in formulation science and drive innovation at the interface of development, analytics and manufacturing to ensure product safety, quality and scalability. What you will get: This is a competitive, salaried paid position. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge. What you will do: Apply deep expertise in biophysics, colloidal chemistry, and pharmaceutical sciences to understand degradation pathways (aggregation, precipitation, potency loss) and translate them into rational formulation designs. Generate and interpret data from orthogonal analytical methods (e.g., infectivity assays, particle characterization, chromatography, and potency/stability readouts) to define and refine formulation design space. Develop and author technical reports describing formulation rationale, stability data, and control strategies for viral vector drug products in support of regulatory filings. Function as a technical leader and subject matter expert within Lonza, mentoring junior scientists and associates and shaping best practices, workflows, and platform approaches for viral vector formulations. Represent formulation science in project teams and internal, as well as external collaborations, clearly communicating data, risks, and recommendations to stakeholders in development, quality, regulatory, and manufacturing. Drive continuous improvement and innovation by evaluating new excipients, technologies, and analytical tools relevant to viral vector formulation, with an emphasis on scalability, robustness, and cost-effective manufacturing. What we are looking for: Highly skilled in formulation studies (stability, solubility, excipients) as well as design and optimization of both frozen and liquid biopharmaceutical drug products. Strong analytical background and familiarity with HPLC, DLS, MALS and relevant biophysical/biochemical assays to characterize impurities, product integrity and activity to direct formulation screening. Experience with viral vector is highly preferred, including viral vector biology, upstream and downstream unit operations and an understanding how they impact product quality attributes. Ph.D., or Master’s degree in chemistry, pharmaceutical sciences, or a related life sciences field with industrial formulation development for regulated and GMP-compliant pharmaceutical applications, or equivalent relevant research experience in academia as evidenced by high profile peer-reviewed publications. About Lonza: At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Requirements

Highly skilled in formulation studies (stability, solubility, excipients) as well as design and optimization of both frozen and liquid biopharmaceutical drug products.
Strong analytical background and familiarity with HPLC, DLS, MALS and relevant biophysical/biochemical assays to characterize impurities, product integrity and activity to direct formulation screening.
Ph.D., or Master’s degree in chemistry, pharmaceutical sciences, or a related life sciences field with industrial formulation development for regulated and GMP-compliant pharmaceutical applications, or equivalent relevant research experience in academia as evidenced by high profile peer-reviewed publications.

Nice To Haves

Experience with viral vector is highly preferred, including viral vector biology, upstream and downstream unit operations and an understanding how they impact product quality attributes.

Responsibilities

Apply deep expertise in biophysics, colloidal chemistry, and pharmaceutical sciences to understand degradation pathways (aggregation, precipitation, potency loss) and translate them into rational formulation designs.
Generate and interpret data from orthogonal analytical methods (e.g., infectivity assays, particle characterization, chromatography, and potency/stability readouts) to define and refine formulation design space.
Develop and author technical reports describing formulation rationale, stability data, and control strategies for viral vector drug products in support of regulatory filings.
Function as a technical leader and subject matter expert within Lonza, mentoring junior scientists and associates and shaping best practices, workflows, and platform approaches for viral vector formulations.
Represent formulation science in project teams and internal, as well as external collaborations, clearly communicating data, risks, and recommendations to stakeholders in development, quality, regulatory, and manufacturing.
Drive continuous improvement and innovation by evaluating new excipients, technologies, and analytical tools relevant to viral vector formulation, with an emphasis on scalability, robustness, and cost-effective manufacturing.