Senior Scientist - Brooklyn Park, United States - Integrated Resources, Inc ( IRI )

Description

Sr Scientist

Brooklyn Park, MN- onsite

Duration: 12+ months

Shift: 1st shift, 40hrs/week

Must Have

• Established knowledge of Analytical Chemistry techniques with application in pharmaceutical and/or medical device industry
• Experience performing laboratory data interpretation including working with mathematical concepts relevant to the laboratory setting
• Experience reading, analyzing, and interpreting common scientific and technical journals, scientific procedures and regulatory guidelines

Nice To Have

• Demonstrated excellent written and oral communication skills
• Experience coordinating work through outside service laboratories
• Knowledge of quality systems and regulatory submissions

HM's Top 3:

1. In-depth knowledge of ISO 10993 and FDA/ISO guidance on their application to medical devices within a risk-based framework.
2. Experience interpreting lab data related to chemical characterization and biological safety testing;
3. Experience writing scientific rationales in lieu of testing.

Education Required: Bachelor's in chemistry, Biochemistry, Materials Science, Biomedical Engineering with a minor in Chemistry/Biochemistry, or equivalent.

Years' Experience Required: 4+ yr with bachelor's, or 2+ yr with advanced degree

40 hr/wk

Please let me know if you are available/interested so we can further discuss this position. Also email me your resume and contact number where I can call you. You can directly email me on my email address or you can give me a call at

Job Summary:

Responsibilities may include the following and other duties may be assigned. Plans, coordinates and leads activities in support of the development and improvement of medical devices used in various therapies that are associated with cardio-vascular surgical procedures. Performs independent research and development activities towards the demonstration of biocompatibility of products using broad judgement to determine the methods and techniques required.

Maintains substantial knowledge of state-of-the-art principles and industry practices. May contribute to scientific literature and conferences and participate in development of patent applications.

• Provides expertise in biocompatibility of medical device materials through knowledge of and experience with biological evaluations in accordance with ISO 10993 and global regulatory filings.
• Determines biocompatibility testing regimen based on type of patient contact and duration of use.
• Identifies master devices to be evaluated to represent multiple devices that share design characteristics and use conditions.
• Collaborates with third party services/test laboratories to obtain quotes and schedule testing.
• Obtain purchase orders and secure required test devices.
• Provides expertise to support extractables & leachables testing of products relevant to use conditions.
• Authors biocompatibility plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.
• Reviews protocols, reports, toxicological risk assessments, and regulatory submission summaries in collaboration with cross-functional team members and test laboratories.
• Analyzes biocompatibility test results to determine adequacy of data to meet requirements for the biological effects. Utilizes problem solving skills and technical knowledge to troubleshoot unexpected results and make scientifically-based decisions on whether additional testing is warranted.
• Assists with regulatory submissions to global regulatory agencies to elaborate on the biocompatibility strategy and data in response to any additional information requests.
• Collaborates with other scientists on material selection based on chemical and biological properties that comply with Materials of Concern (MOC) regulations globally.
• Coordinates product stewardship activities through MOC identification in products using a priori knowledge, supplier safety data sheets, supplier declarations, and lab testing.
• Conducts MOC evaluations for compliance with regulations.
• Collaborates with other subject matter experts to author justifications for the continued use of substances of concern based on solid scientific rationale and benefit-risk assessments.
• Maintains compliance to global MOC regulations of released products through material and supplier changes. Identifies and closes MOC compliance gaps, working with vendors and testing labs.
• Works independently under limited supervision to determine and develop approach to solutions.
• Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Required Knowledge and Experience: Requires bachelor's degree in chemistry, Biochemistry, Materials Science, Biomedical Engineering with a minor in Chemistry/Biochemistry, or equivalent, at a minimum. May have practical knowledge of project management. Requires a minimum of 4 years of relevant experience with Bachelor's, or a minimum of 2 years relevant experience with advanced degree.

Specialized Knowledge or Skills Required

• Established knowledge of Analytical Chemistry techniques with application in pharmaceutical and/or medical device
• industry
• Experience performing laboratory data interpretation including working with mathematical concepts relevant to the
• laboratory setting
• Experience reading, analyzing, and interpreting common scientific and technical journals, scientific procedures and
• regulatory guidelines.
• Experience with performing statistical analysis of data

Desired/Preferred Qualifications:

• Demonstrated excellent written and oral communication skills
• Experience coordinating work through outside service laboratories
• Knowledge of quality systems and regulatory submissions

Responsibilities may include the following and other duties may be assigned. Responsible for the initiation, design, development, execution, and implementation of scientific research projects. Investigates the feasibility of applying scientific principles and concepts to potential inventions and products. Plans and executes laboratory research. Maintains substantial knowledge of stateofthe art principles and theories and may contribute to scientific literature and conferences. May participate in development of patent applications. May coordinate interdepartmental activities and research efforts. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

May have practical knowledge of project management.

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.