Description:

The Analytical Development Senior Scientist will be responsible for development and establishment of analytical assays to be used in the characterization and evaluation of our viral vector and cell product. Candidates are expected to demonstrate the ability to design and conduct critical analytical assays using techniques with cell culture, flow cytometry, molecular biology, virology, and chemical analyses. The Analytical Development Senior Scientist will support activities involving projects and documentation performed internally and externally relating to the evaluation of our viral vector and cell product platforms. This support includes assay and protocol development for vector and cell characterization, killing/phagocytosis, chemical analyses, and vector and cell-based potency assays.

The candidate is expected to also perform routine and custom assays, review results, and aid in validation/qualification.

Responsibilities:

Responsible for resource management and initiating timely resource planning based on production forecasts and business needs

Help to establish the growing Analytical Development laboratory, including parameters related to facilities, instruments, processes, and procedures

Manage projects in collaboration with other team members, both internally and at external contract development and manufacturing organizations, to evaluate and implement new analytical and process technologies to develop next generation Cell and Gene Therapeutics

Lead, schedule, and execute laboratory studies for development, optimization, and manufacturing of vector and cell product including design, planning, execution, analysis, and reporting

Execute analytical method for validation/qualification and perform routine testing using analytical techniques for cell culture, flow cytometry, killing/phagocytosis, molecular biology, virology, chemical analyses, and vector and cell-based potency assays

Write and conduct routine assays in compliance with Carisma Standard Operating Procedures

Manage samples inventory, raw materials, and reference standards.

Participates in investigations related to assay failures, system deficiencies, deviations, equipment, and assay troubleshooting

Participates in transferring methods and procedures for new assignments as required

Participate in the batch record review process, including escalation of issues and maintain timelines for reporting

Author and review protocols, technical reports, regulatory source documents and memos to summarize experiments and support investigations

Support Regulatory submissions and Quality Assurance with technical content and expertise

Appropriately analyze data, interpret results, maintain and review laboratory notebook and logbook; prepare and deliver presentations at team meetings

Interact with internal cross-functional team members including Research, Process Development, Quality Control, Manufacturing, Nonclinical, Clinical, Quality Assurance, Regulatory, and Legal

Work effectively in a team environment to meet project timelines and objectives

Occasional travel may be required

Perform other duties as assigned

***VIROLOGY EXPERIENCE REQUIRED***

Skills:

cell based assay, vector, characterization, killing/phagocytosis, ELISA, HPLC, cell culture, potency assay, virus, Digital PCR, Infectivity

Top Skills Details:

cell based assay,vector,characterization,killing/phagocytosis,ELISA,HPLC,cell culture,potency assay,virus,Digital PCR,Infectivity

Additional Skills & Qualifications:

A degree in biology, biochemistry, chemical/bioengineering, cell biology, immunology, virology, or related discipline and

BS with 6+ years of relevant experience

MS with 4+ years of relevant experience

PhD with 1+ years of relevant experience

Biopharmaceutical industry experience preferred, in analytical assay development, GLP/GMP testing facility, or research and discovery

Proficient in target specific primer and probe assay design, blast, and alignment

A strong background in several of the following areas of expertise: cell culture, potency assays, infectivity assays, cell-based analytical methods, flow cytometry, killing/phagocytosis, MSD, ELISAs, qPCR, ddPCR, and other molecular based assays, HPLC and other physical/chemical-based technologies with expectations for significant expertise in developing, optimizing and qualification or validation of assays

Proven ability to critically analyze data and interpret results

Experience authoring and reviewing written records of work in the form of laboratory notebooks (paper or electronic)

Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, interpersonal skills, and a helpful team spirit

Able to read, comprehend, and make appropriate alterations to documents such as batch records, SOPs, etc

Proficiency with Microsoft Excel and statistical analysis software for analyzing and presenting data

Ability to function in a rapidly changing environment and balance multiple priorities simultaneously

Able to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees

Effective personal organization and time management skills

Highest moral and ethical integrity

A desire and willingness to learn, adaptability, and a “can do” attitude

Preferred:

Experience in development of potency panel assays for viral vector and cell product

Knowledge and understanding of current Good Manufacturing Practices (cGMP

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.