Sr Scientist, Quality Control and AD

PACKGENE BIOTECH INC•Houston, TX

57d•Onsite

About The Position

Sr Scientist, Quality Control and Analytical Development (QCAD) is responsible for providing scientific and technical leadership in support of analytical development and GMP Quality Control activities for gene therapy products. The incumbent will lead and execute analytical method development, optimization, qualification/validation, method transfer, troubleshooting, and implementation of methods for routine GMP testing. The focus area of this role is primarily on HPLC methods but will be involved with other analytical methods. The Sr Scientist will serve as a technical resource within QCAD, applying scientific expertise to the development and lifecycle management of analytical methods supporting raw materials, in-process samples, drug substance, drug product, stability, characterization, and product release testing. The role will lead new project implementation and execution in a timeline-driven manner, support client and cross-functional technical interactions, and mentor junior scientists and laboratory staff. The final job title, level, and scope of responsibilities may be adjusted to Scientist I, Scientist II, or Senior Scientist based on the selected candidate’s education, relevant experience, technical expertise, and demonstrated capabilities.

Requirements

Ph.D. or M.S. in Biology, Biotechnology, Bioengineering, Chemistry, Pharmaceutical Sciences or other relevant scientific field.
6-8+ years of relevant industry experience with a Ph.D. or 8-10+ years with M.S., preferably supporting biologics, viral vector, cell and gene therapy products.
Demonstrated experience in analytical method development, optimization, qualification/validation, transfer, troubleshooting, and/or implementation into routine GMP testing.
Experience applying scientifically sound experimental design, statistical analysis, Quality by Design (QbD), and/or Design of Experiments (DOE) approaches to analytical development and optimization activities is preferred.
Strong working knowledge of cGMP laboratory requirements and regulatory expectations applicable to analytical development and Quality Control within an FDA-regulated environment.
Working knowledge of analytical procedure development and validation principles, including applicable ICH Q2 and ICH Q14 expectations, is preferred.
Demonstrated understanding of good documentation practices, data integrity, laboratory controls, specifications, reference standards, critical reagents, instrument qualification, and GMP analytical testing.
Demonstrated ability to work cross functionally in multi-disciplinary teams.
Hands-on experience with multiple analytical technologies used for viral vector or biologics release and characterization, which may include qPCR/ddPCR, ELISA, electrophoresis, HPLC/chromatography, cell-based assays, potency assays, and other molecular, biochemical, biophysical or microbiological methods.
Ability to manage multiple analytical projects and priorities while meeting development, manufacturing, and GMP testing timelines.
Proficient in MS Office and applicable laboratory data tools.
Ability to independently prioritize and manage multiple projects, studies and laboratory activities.
Strong problem-solving, critical-thinking, and root-cause analysis skills.
Excellent written and oral communication skills, with demonstrated ability to communicate complex scientific concepts, experimental results, risks, conclusions, and recommendations to technical teams, leadership, clients, and other stakeholders.
Strong collaboration and influencing skills in multidisciplinary and cross-functional environments.
Strong project planning and organizational skills, including the ability to establish study plans, timelines, milestones, and deliverables.
Demonstrated ability to mentor and technically develop junior scientists and laboratory personnel.
High level of scientific curiosity, accountability, attention to detail, and commitment to data integrity and continuous improvement.

Nice To Haves

Experience applying scientifically sound experimental design, statistical analysis, Quality by Design (QbD), and/or Design of Experiments (DOE) approaches to analytical development and optimization activities.
Working knowledge of analytical procedure development and validation principles, including applicable ICH Q2 and ICH Q14 expectations.

Responsibilities

Lead and participate in laboratory capability development activities, including implementation of new analytical technologies, equipment acquisition and qualification, method implementation, laboratory readiness, and coordination with vendors and internal stakeholders.
Maintain a high level of scientific and technical expertise in analytical technologies applicable to viral vectors, biologics, and gene therapy products.
Design, develop, optimize, and troubleshoot analytical methods supporting product characterization, process development, in-process control, release, and stability testing.
Lead analytical method qualification/validation, verification, transfer, comparability, and implementation activities, including development of study strategies, protocols, acceptance criteria, data analysis, and technical reports.
Serve as a technical owner and subject matter expert for assigned analytical methods and platforms, providing scientific oversight throughout the analytical method lifecycle.
Provide technical leadership across analytical technologies that may include qPCR/ddPCR, ELISA, electrophoresis, HPLC/chromatographic methods, cell-based assays, potency assays, and other molecular, biochemical, biophysical, or microbiological methods.
Perform and provide technical oversight for routine and non-routine GMP testing of raw materials, in-process samples, drug substance, drug product, stability samples, characterization samples, and other materials, as applicable.
Participate in technical discussions with clients and serve as a QCAD subject matter expert for assigned analytical methods, assay strategies, investigations, and analytical development activities.
Lead and support analytical method transfers from Analytical Development, Process Development, clients, external laboratories, or other sites into the GMP QCAD laboratory, ensuring methods are appropriately implemented and analysts are successfully trained and qualified.
Independently design and execute analytical development, characterization, method optimization, comparability, routine QC testing, and troubleshooting studies using scientifically sound experimental approaches.
Establish appropriate experimental designs, controls, system suitability criteria, and acceptance criteria based on method purpose, scientific principles, product development stage, and regulatory expectations.
Perform timely data acquisition, advanced data analysis, statistical evaluation, interpretation, and troubleshooting; clearly communicate conclusions, risks, recommendations, and project progress in technical and cross-functional meetings.
Review and interpret complex analytical data and identify trends, variability, assay drift, or method performance issues requiring further investigation or improvement.
Lead technical troubleshooting and laboratory investigations associated with assay failures, invalid results, atypical results, OOS/OOT events, deviations, instrument issues, reagent performance, or method-related variability.
Provide scientific input into root cause investigations, CAPAs, change controls, risk assessments, and continuous improvement activities.
Draft, review, and approve technical and controlled laboratory documentation, including analytical methods, SOPs, specifications, protocols, qualification/validation reports, transfer reports, technical assessments, investigations, and study reports.
Ensure experimental and GMP activities are documented contemporaneously and accurately in accordance with cGMP, good documentation practices, and data integrity requirements.
Support establishment, qualification, and lifecycle management of critical reagents, standards, controls, and reference materials used in analytical testing.
Coach and mentor junior scientists and laboratory staff on scientific principles, experimental rationale, study design, assay execution, data interpretation, troubleshooting, GMP expectations, and technical documentation.
Provide technical training and support analyst qualification for methods and technologies within the Sr Scientist's areas of expertise.
Collaborate with Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, Project Management, and other functions to establish appropriate analytical strategies and ensure testing supports development and manufacturing timelines.
Support preparation for and participation in client audits, internal audits, and regulatory inspections as a technical SME, as applicable.
Evaluate new analytical technologies, automation, alternative methods, and process improvements to increase laboratory capability, assay robustness, efficiency, and testing capacity.
Demonstrate a high level of accountability, scientific integrity, and communication and foster a culture of collaboration, compliance, trust, and teamwork.
Build strong, cohesive working relationships with colleagues across the company to accomplish goals.
Other duties as assigned