Sr. Scientist II, Biologics - Contract

TalentBurst, Inc.

Aliso Viejo, CA

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JOB DETAILS

SALARY

$56.73–$71.15 Per Hour

SKILLS

Analysis Skills, Analytical Chemistry, Analytical Development, Assay Development, Assay Methods, Assays, Biochemistry, Biological Assay, Biotech and Pharmaceutical, CMOS, Chromatography, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Decision Support, Detail Oriented, Droplet Digital PCR (ddPCR), Drug Delivery Systems, Drug Development, Drug Manufacturing, Drug Products, Drug Release, FDA (Food and Drug Administration), GxP, High Performance Liquid Chromatography (HPLC), ICH Regulations, Identify Issues, Leadership, Leading Edge Technology, Liquid Chromatography-Mass Spectrometry (LC-MS), Microsoft Windows CE Operating System, Multitasking, New Drug Application, People Management, Presentation/Verbal Skills, Product Testing, Project Evaluation, Project/Program Management, Quality Control, Real-time PCR (qPCR), Regulations, Regulatory Compliance, Regulatory Submissions, Requirements Management, Securities and Exchange Commission (SEC), Small Molecules, Strategic Planning, Technical Support, Technical/Engineering Design, Time Management, Training/Teaching, Trend Analysis, Writing Skills

LOCATION

Aliso Viejo, CA

POSTED

1 day ago

Title: Sr. Scientist II, Biologics
Location: Aliso Viejo, CA 92656
Direct Hire Position

Vertical Description:
What You ll Do:

This position is within the Analytical Technologies team of the Applied Research department. This role focuses on developing, validating, and transferring analytical and biological potency assay and cell-based assay methods to support large molecule drug development and formulations from early-stage clinical studies through commercialization. The position also involves overseeing stability studies and conducting trending analysis. The position will establish, coordinate and monitor analytical related activities both internally and with CROs and CMOs to ensure quality and timeliness of projects. The ideal candidate works effectively and collaboratively with cross-functional groups and will represent as analytical lead on CMC project teams. This position is expected to communicate data both verbally at group meetings and through written documents and reports and be able to comfortably multitask across projects and disciplines.

Provides technical expertise to design, conduct, and implement analytical and development activities for large and small molecules to support all stages of drug development.
Troubleshoots and solves technical challenges independently in a timely manner and ensures generation of high-quality scientific data.
Evaluates and interprets data from release and stability studies and provides scientific conclusions to support decision making.
Maintains expertise in cutting-edge assay technologies and continuously develops excellent assay troubleshooting skills in analytical methodologies used for the characterization of drug delivery systems and protein formulations for drug release, potency, biological activity, stability, impurity testing and aggregation profile.
Collaborate with protein/peptide engineering SMEs and contribute biological knowledge to the design of Client proteins with desired pharmacological characteristics.
Prepares high quality experimental protocols and technical reports in support of regulatory submissions.
Independently authors appropriate portions of CMC section of INDs, NDAs and prepares responses to regulatory questions.
Provides training and guidance to scientists in the team.
Provides regular and open communication to keep project teams, and management informed of direction, progress and strategic developments in supporting and meeting companies goals and objectives.
Actively participates in departmental committees/meetings as an advisor in scientific, administrative and regulatory areas.
Represents as analytical lead on CMC project teams, provides scientific solutions and contributes to team discussions.
Support QC department with establishing robust methods, product specifications, method validations and method transfers.
Proactively develops and maintains knowledge in current analytical and bioanalytical sciences and investigates new technologies, recommends and implements innovative techniques to the team.

Requirements:
How You ll Get There: Strong hands-on knowledge of chromatographic theory and technology. Working knowledge of HPLC, UPLC, IEX-HPLC, SEC-HPLC, LC-MS, CE techniques, cIEF, MSD, ELISA, ddPCR, qPCR, Octet, Biacore, and other common analytical and bioassay techniques used to determine potency, purity, and in-vitro performance of drug substance and drug product for large molecules. Ability to independently lead investigations and troubleshoot technical problems at all stages of development, being detail oriented are important attributes. Excellent written and verbal communication skills; prior experience working within regulated environments (e.g., GxP, ICH, FDA) to ensure analytical activities meet compliance standards and support regulatory filings and inspections. Strong ability and knowledge to develop, validate and transfer methods. Experience in oversight of stability studies, conducting trend analysis and interpreting data. Strong scientific and leadership skills with the ability to be a subject matter expert at matrix teams and influence and collaborate. Ability to work within a diverse workforce, scientific participation and collaboration with colleagues in industry, academia and regulatory agencies. Experience in interacting with pharmaceutical CROs and CMOs and providing guidance. Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. Good knowledge of drug development and product regulations. Ph.D. (with 8 years) or M.S. (10 years) in biochemistry, immunoanalytical/analytical chemistry, or related scientific field and 6 years of pharmaceutical industry experience in large molecule analytical development, drug product analysis and regulatory submissions.

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About the Company

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

COMPANY SIZE

5,000 to 9,999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2002

WEBSITE

http://www.talentburst.com/