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Job Description
Duties:
Author and finalize appropriate Module 3 documents and responses to agency questions in collaboration with Regulatory CMC and technical subject matter experts.
Experience in analytical method development for vector and T cell products, including extended characterization, with awareness of ICH guidelines and global compendial requirements governing analytical development and characterization/comparability of advanced therapy medicinal products and vector intermediates.
Qualifications:
Bachelor's, master's, or PhD in biochemical engineering, chemical engineering, biomedical engineering, biotechnology, biology, biochemistry, or equivalent, with 7+ years (Bachelor's), 5+ years (Master's), or 3+ years (PhD) of relevant experience.
Experience with CMC/Module 3 regulatory submissions.
Proficiency in technical writing and high-quality documentation.
Knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and analytical and process development.
Thorough knowledge of biologics analytical methods and process development; cell therapy process development experience is highly desirable.
Understanding of product lifecycle stages including product and process development, clinical trials, validation, regulatory submissions, and GMP manufacturing.
Working knowledge of regulatory requirements for biologics, pharmaceuticals, and medical devices.
Why Choose
R&D Partners? As an employee, you have access to a comprehensive benefits package including: Medical insurance – PPO, HMO & HSA Dental & Vision insurance 401k plan Employee Assistance Program Long-term disability insurance Weekly payroll Expense reimbursement Online timecard approval Pay Scale: $160,000 - $166,000 annually ( dependent on experience ) R&D Partners is a global staffing and strategic resource provider specializing in scientific, clinical research, and engineering fields. We offer job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.
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R&D Partners? As an employee, you have access to a comprehensive benefits package including: Medical insurance – PPO, HMO & HSA Dental & Vision insurance 401k plan Employee Assistance Program Long-term disability insurance Weekly payroll Expense reimbursement Online timecard approval Pay Scale: $160,000 - $166,000 annually ( dependent on experience ) R&D Partners is a global staffing and strategic resource provider specializing in scientific, clinical research, and engineering fields. We offer job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.
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