Associate Scientist MSAT Advanced Therapies ValidationsUS Tech Solutions • Somerville, NJ, US

Associate Scientist MSAT Advanced Therapies Validations

US Tech Solutions • Somerville, NJ, US

1 day ago

Job type

Full-time

Temporary

Job description

Job Description

Duration : 12 months contract, Full-Time

Employment Type : W-2

Job Description :

The Associate Scientist MSAT Advanced Therapies Validation is responsible for validating supporting processes, implementing improvements within commercial manufacturing, and managing the lifecycle of these processes. The Associate Scientist acts as a Subject Matter Expert for validation studies, particularly in optimizing commercial manufacturing of lentiviral vectors, and liaises with various stakeholder departments.

Responsibilities :

Contribute to Life Cycle Management (LCM) and New Technology Introduction for the site.

Execute validation of supporting processes (e.g.,mixing, sterilization, thermal processing, bio-decontamination).

Support the introduction of new technologies and digitalization projects through validation protocol execution.

Support the introduction of new materials via execution of validation protocols.

Validate process parameters (e.g., process hold times).

Contribute to Life Cycle Management projects.

Act as Subject Matter Expert for one or more validation categories. Leverage the global MSAT network to identify and implement best practices.

Author and review well-documented protocols and reports for all processes to be qualified / validated, in accordance with corporate / site guidelines, procedures, regulatory requirements, and industry best practices.

Coordinate and support the execution of validation studies that conform to site standards and client guidelines, while meeting quality requirements.

Support the site change control program by performing validation impact assessments and delivering the resulting implementation plan.

Investigate deviations associated with process validation activities and oversee pre-validation and validation activities resulting from technical changes.

Propose and formalize enhancements to qualification and validation processes and procedures to support process validation throughout the lifecycle and ensure program sustainability.

Assist with writing Quality Risk Assessments for existing and new or changed processes.

Ensure integration of global standards into local production processes.

Support complex investigations and risk assessments.

Act as SME during internal and external audits and inspections.

Experience :

Minimum of 2 years of relevant Manufacturing, Science, & Technology experience in the pharmaceutical industry.

Experience with cell therapy manufacturing or viral vector manufacturing.

GMP manufacturing and / or validation experience in pharmaceuticals.

Skills in communication, planning, documentation, risk management, root cause problem-solving, and knowledge management.

Understanding of regulatory requirements and industry guidelines for validation (e.g., FDA, EMA, ICH, ASTM, ISO, ISPE, PDA, etc.).

Affinity with process technology and digitalization in manufacturing.

Capable of successful delivery of local small projects, regional project work streams, or departmental programs under supervision. Selects applicable engineering / scientific tactics.

Works independently within scope, requiring general guidance.

Skills :

Stem Cell Therapy

Good Manufacturing Practices (GMP)

Drug Manufacturing

Education :

BSc in Biochemistry, Biotechnology, Chemical Engineering, or a related field.

Advanced degree (MSc / PhD) in Biochemistry, Biotechnology, Chemical Engineering.

About US Tech Solutions :

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details : Name : Azhar

Email : Azhar@ustechsolutionsinc.com

Internal Id : 25-53773

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Associate Scientist • Somerville, NJ, US

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