Manufacturing Transfer Specialist
2 weeks ago
A leading biotechnology firm is seeking a Technical Transfer Specialist to enhance Operations, Development, and Regulatory functions during the introduction of new Assays, Reagents, and Bulk Materials. This role is crucial in ensuring that all operational requirements are fulfilled from perspectives of manufacturability, quality, cost, and scheduling.
Key Responsibilities
- Communicate and implement manufacturing best practices to the core project team, ensuring scalability and manufacturability.
- Facilitate understanding and communication of all operational stakeholders' needs (including Manufacturing, Process Engineering, Validations Engineering, and Quality) throughout the transfer process.
- Apply Technology Transfer standard practices to continuously enhance the transfer process.
- Utilize project management techniques to plan, monitor, and ensure the timely completion of transfer projects.
- Develop expertise in site manufacturing processes to promote and enhance GMP, ensuring successful transfer activities in terms of cost, quality, and delivery.
- Incorporate manufacturing requirements into development projects to guarantee effective technical transfer into operations by providing input during the design phase.
- Execute Validation protocols with support from fellow Technical Transfer Specialists, adhering to Good Manufacturing Practices (GMP) and standards for transferred products.
- Engage in cross-functional teams to ensure the objectives of the technology transfer project are achieved.
- Identify and troubleshoot issues as they arise.
- Contribute to transfer planning and process updates.
- Prepare and present project results to diverse audiences, effectively communicating data.
Qualifications
- Bachelor's Degree in Engineering/Engineering Technology or Life Science with 1-3 years of relevant experience, or a Master's Degree in the same fields with 0-2 years of experience.
- Demonstrated potential for technical proficiency, scientific creativity, collaboration, and independent thought.
- Basic understanding of assay, bulk, and reagent manufacturing processes and the ability to apply scientific methods related to production.
- Strong technical writing skills for report and document creation.
- Ability to implement Six Sigma and Lean Manufacturing methodologies during the development phase.
- Familiarity with systems such as SAP and ETQ.
Compensation:
- $53,248-$66,560
Why Choose R&D Partners?
As an employee, you will benefit from a comprehensive benefits package that includes:
- Medical insurance options – PPO, HMO & HSA
- Dental & Vision insurance
- 401k retirement plan
- Employee Assistance Program
- Long-term disability coverage
- Weekly payroll schedule
- Expense reimbursement opportunities
- Online timecard approval system
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research, and engineering. 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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