Staff Scientist

Smith+Nephew•Fort Worth, TX

1d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Staff Scientist – Microbiologist will serve as a scientific and technical leader within the Wound Operations business, supporting product and process improvement through deep expertise in microbiology, enzymology, and data analysis. This role focuses on understanding, designing, and optimizing microbiologically driven systems and interactions that underpin product performance, safety, and clinical relevance. Working in a highly matrixed environment, you’ll collaborate across R&D, Engineering, Quality, Regulatory, Manufacturing, and Marketing to advance programs from early innovation through commercialization. What will you be doing? Lead the design, execution, and interpretation of microbiological and enzymatic studies (e.g., enzyme activity/kinetics/stability/inhibition; functional performance in biologic systems). Develop, optimize, and validate enzymatic and microbiological assays (bacterial growth, enzyme expression, functional activity, MOA-based assays). Provide subject matter expertise on microbial interactions, enzymatic mechanisms, and biological system behavior relevant to wound healing, regenerative medicine, and biologics. Interpret enzyme-driven and microbiology data to inform product safety, efficacy, and differentiation. Develop, maintain, and characterize master and working cell banks in line with regulatory and internal quality standards; own and update procedures for bacterial cell bank maintenance. Independently investigate and prototype process/method improvements tied to productivity and sustainability; apply in-process data and statistical analysis to continuously improve methods. Contribute to pipeline strategy by identifying opportunities that improve productivity and resilience; partner with internal/external thought leaders to track emerging technologies and competitive trends. Collaborate closely with Regulatory Affairs, Clinical, Quality, Manufacturing, and Marketing to align biology, claims, and regulatory strategy; support regulatory submissions (e.g., BLA, biological safety documentation) with clear scientific rationale and data interpretation. Select, manage, and technically oversee external CROs/vendors supporting microbiological and enzymatic studies; communicate complex concepts to technical and non-technical stakeholders. Apply project management principles to deliver milestones, KPIs, and timelines; lead troubleshooting and root-cause investigations related to enzymatic performance, microbiological variability, aseptic process failures, or assay failures. Provide technical oversight and mentorship to junior scientists and cross-functional teams; serve as a scientific SME for biologics and enzyme-based technologies. What will you need to be successful? Bachelor’s in microbiology required. PhD in Microbiology or related field preferred. Deep understanding of enzyme-driven biological systems and microbial behavior. Strong experimental design, data/statistical analysis, and scientific writing skills, with meticulous documentation and data integrity practices. Ability to work independently while influencing outcomes in a matrixed organization; strong verbal and written communication skills. Proven ability to present, influence, and align stakeholders around scientific strategy; capable of working with minimal direction. Ability to manage multiple concurrent initiatives, adapt to shifting priorities, and collaborate effectively in teams.

Requirements

Bachelor’s in microbiology required.
Deep understanding of enzyme-driven biological systems and microbial behavior.
Strong experimental design, data/statistical analysis, and scientific writing skills, with meticulous documentation and data integrity practices.
Ability to work independently while influencing outcomes in a matrixed organization; strong verbal and written communication skills.
Proven ability to present, influence, and align stakeholders around scientific strategy; capable of working with minimal direction.
Ability to manage multiple concurrent initiatives, adapt to shifting priorities, and collaborate effectively in teams.
Required: 10+ years’ experience in biologics and medical device product development.

Nice To Haves

PhD in Microbiology or related field preferred.
Experience in fermentation processes, cGMP, GLP, aseptic processing, and related manufacturing procedures.

Responsibilities

Lead the design, execution, and interpretation of microbiological and enzymatic studies (e.g., enzyme activity/kinetics/stability/inhibition; functional performance in biologic systems).
Develop, optimize, and validate enzymatic and microbiological assays (bacterial growth, enzyme expression, functional activity, MOA-based assays).
Provide subject matter expertise on microbial interactions, enzymatic mechanisms, and biological system behavior relevant to wound healing, regenerative medicine, and biologics.
Interpret enzyme-driven and microbiology data to inform product safety, efficacy, and differentiation.
Develop, maintain, and characterize master and working cell banks in line with regulatory and internal quality standards; own and update procedures for bacterial cell bank maintenance.
Independently investigate and prototype process/method improvements tied to productivity and sustainability; apply in-process data and statistical analysis to continuously improve methods.
Contribute to pipeline strategy by identifying opportunities that improve productivity and resilience; partner with internal/external thought leaders to track emerging technologies and competitive trends.
Collaborate closely with Regulatory Affairs, Clinical, Quality, Manufacturing, and Marketing to align biology, claims, and regulatory strategy; support regulatory submissions (e.g., BLA, biological safety documentation) with clear scientific rationale and data interpretation.
Select, manage, and technically oversee external CROs/vendors supporting microbiological and enzymatic studies; communicate complex concepts to technical and non-technical stakeholders.
Apply project management principles to deliver milestones, KPIs, and timelines; lead troubleshooting and root-cause investigations related to enzymatic performance, microbiological variability, aseptic process failures, or assay failures.
Provide technical oversight and mentorship to junior scientists and cross-functional teams; serve as a scientific SME for biologics and enzyme-based technologies.