Senior Scientific Investigator - Combination Products (Finance)

Senior Scientific Investigator - Combination Products

SUMMARY:

The Pharmaceutics Operations Laboratory Senior Scientific Investigator - Combination Products collaborates with cross-functional teams, including Technical Operations, Quality, Regulatory Affairs and Third-party suppliers, in support of the Bracco Nuclear Medicine Portfolio. The individual is responsible for providing technical expertise on medical devices, with a focus on the CardioGen-82® Infusion System, and associated disposables. Responsibilities also include working with combination devices in the pharmaceutical industry, with emphasis on troubleshooting and root cause investigations to ensure product performance, safety, and compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Participate in the identification and execution of testing strategies in support of product development/improvement projects.
• Provide technical support to non-routine (e.g. deviation, complaint) investigations to identify both root cause and remediation solutions.
• Provide technical oversight/support to contract manufacturers and other third-party suppliers/service providers.
• Utilizes creative thinking and organizational skills to help solve complex problems in creative and effective ways, complete projects as assigned and achieve goals.
• Maintains detailed records of laboratory activities. Prepares reports and presentations to communicate progress to stakeholders.
• Proficiency in using laboratory equipment and software for data analysis.
• Strong ability to communicate and present complex information clearly. Experience in technical writing and documentation.
• Experience in supporting multiple projects and collaborating with cross-functional teams to meet deadlines and deliver high-quality results.

SECONDARY DUTIES AND RESPONSIBILITIES:

• Supervise / train staff, as assigned.
• Perform document reviews and contract vendor site visits/inspections, as needed.
• Participates in Process Capacity Analyses, Risk Assessments, and FMEA evaluations.
• Works well with intermittent supervision.

SUPERVISORY RESPONSIBILITIES:

As needed/assigned.

CORE COMPETENCIES:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the core competencies required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to lead and work independently.
• Continuous Improvement mindset.

EDUCATION and/or EXPERIENCE REQUIRED:

• BS or MS degree or equivalent in chemistry, engineering or a related pharmaceutical science with at least 5 years of experience working with combination devices in the pharmaceutical industry.

• Experience with mechanical testing and measurement equipment techniques.
• Familiarity with Design Verification strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, and ensuring appropriate selection of acceptance criteria and sampling plans.
• Collaborative and supportive team player.
• Lead with strong scientific knowledge, effective use of relevant scientific information, and problem-solving ability.
• Strong understanding of parenteral drug and medical device development practices and regulatory compliance (QSR / ISO13485 / ASTM Standards, etc.).
• Strong written and oral communication skills.

CERTIFICATES, LICENSES, REGISTRATIONS:

• Not Required

PHYSICAL DEMANDS:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Physical demands include handling of materials, reagents and equipment necessary to operate and perform maintenance activities and remove waste from the laboratory.
• Domestic or international travel may be required.

WORK ENVIRONMENT:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

CORE RELATIONSHIPS:

• Relationships include interdisciplinary functions and departments including BDI Technical Operations, Quality, Regulatory Affairs, third-party contract manufacturers and laboratory service providers.

• Work with Legal re NDA, patents, etc., as appropriate.