Associate Project Manager (Medical Device)

301055 Fenwal, Inc.; Lake Zurich (IL); On-site; USD 75,000 - 80,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holiday and personal/pd

Employee assistance program

Health benefits: medical, prescription

Dental and vision coverage

Job summary

Fresenius Kabi USA Lake Zurich seeks an Associate Project Manager to support biocompatibility and material qualification activities for the Transfusion and Cell Therapies business. You will coordinate outsourced studies, manage protocols and reports, and help ensure compliant execution of testing.

Under guidance of a Senior PM and SME, you will handle documentation, risk assessments, supplier coordination, and maintain the qualification database.

Qualifications

• Bachelor’s degree in chemistry, biology, or related discipline 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 incl. USP <87>, <88>.
• Advanced knowledge of Office (Outlook, Word, Excel, PowerPoint).

Responsibilities

• Coordinate Fresenius Kabi Lake Zurich biocompatibility program for material qualification.
• Prepare, review and approve protocols and reports for materials testing.
• Support testing programs through risk assessment and documentation.
• Identify risks and develop response strategies.
• Coordinate with CROs and manage supplier quality audits.
• Ensure conformance to 21 CFR Part 58 (GLP) and related regulations.
• Maintain the qualification database and archive study documentation.

Skills

Project coordination

Biocompatibility

Documentation management

Communication skills

ISO knowledge

MS Office

Education

Bachelor's degree in chemistry or biology

Tools

Microsoft Office

LIMS

Job description

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.

Salary Range: $75,000-$80,000 based on experience.
Position is eligible to participate in a bonus plan with a target of 6% of the base salary (include only if applicable to the grade level).
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include:

• 401(k) plan with company contributions
• Paid vacation, holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

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, <87>, <88>, <151>, <661>, <1031>, <1184> 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.
• This job position within the Business Unit – Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources.
• Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).

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 <87>, <88>, <151>, <661>, 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, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face.

Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.