Associate Project Manager (Medical Device)

Job Summary

The Associate Project Manager provides support for medical device material qualification activities for the Transfusion and Cell Therapies business within Fresenius Kabi's Medical Device division. Working under the guidance of an experienced Project Manager and Subject Matter Expert, this individual coordinates outsourced biocompatibility studies, chemistry assessments, and other chemistry- and project-related activities.

The candidate is responsible for administering the requirements, processes, procedures, sample handling, and associated documentation necessary to ensure the compliant execution of biocompatibility studies and related activities.

Responsibilities

• Provide coordination, communication and support of Fresenius Kabi Lake Zurich Biocompatibility program for a high volume of material qualification projects (preclinical biological safety studies) in accordance with ISO 10993, ISO 3826, OECD, USP , , , , , , FDA consensus standards, EU Medical Device Regulations, and related guidance.
• Support the Chemistry / Biocompatibility function through preparation, review and approval of protocols and reports for materials qualification and biocompatibility testing.
• Support implementation of a thorough and conforming testing program through risk assessment, gap analysis and documentation. Identify and communicate risks and support development of response strategies.
• Support engineering colleagues with preparation of materials qualification documentation.
• Work closely with functional Director and broader team to support development and maintenance of policies and standards for the processes of medical device material qualification, including review and preparation of nitrosamine risk assessments and elemental impurities risk assessments.
• Work closely with Contract Research Organizations (CRO), coordinate relationships with CROs and support implementation of Master Service Agreements, and participate in supplier quality lab audits.
• Coordinate and review technical aspects of study protocols and reporting from CROs, with guidance from the appropriate SME. Assure CRO conformance to regulations including 21 CFR, Part 58 (GLP). Communicate findings, investigate non-conforming test results, collaborate to resolve issues.
• Report results of qualifications to project teams and manage a system and process for ready retrieval of a growing database of material qualification results.
• Provide cost estimates for studies to Project Engineers/Directors.
• Ensure all related study documentation is effectively managed and archived in the official documentation system.

Requirements

• Bachelor's Degree in chemistry, biology, or other related discipline is required.
• Minimum 3 years of experience in a related role.
• 1 year of project management experience preferred.
• Familiarity with ISO 10993-1 and related parts, including ISO 10993-18, 19, USP , , , , PhEur Chapter 3.
• Advanced knowledge of office computers/systems including Outlook, Word, Excel, PowerPoint. Demonstrated proficiency with Internet/Intranet applications and research.
• Demonstrated history of success in coordinating outsourced scientific service providers.
• Demonstrated experience coordinating scientific studies.
• High attention to detail and excellent analytical and oral and written communication skills to effectively communicate with internal and external R&D personnel and contract lab study directors.
• Exposure/experience working in a chemistry or life science lab is desirable.
• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position.