Sr Specialist R&D, Stability at Medline Industries, Inc. in Mundelein, Illinois

Job Description:

Job Summary

The Sr Specialist will work with internal business partners and product development teams to provide stability support.  This role is responsible for writing and reviewing stability protocols/reports, evaluating product changes, performing risk assessments, updating procedures, and leading process improvements.  This position plays a critical role in setting expiration dates for medical devices, drugs, and cosmetics.

Job Description

Responsibilities:

• Direct stability studies required in support of product claims.




• Determine the tests and acceptance criteria required for stability in collaboration with testing subject matter experts and product divisions




• Author, review, and approve test protocols and reports.




• Evaluate and trend stability data




• Support and consult internal business partners related to stability topics




• Perform gap assessments on stability studies




• Evaluate the impact of product change to stability studies




• Lead stability process improvements

Qualifications:

• Bachelor’s degree in Chemistry, Biology or related science field.




• A least 4 years of experience in a medical device or pharmaceutical related field.




• Knowledge of FDA requirements and experience with FDA interactions as part of the 510k/ANDA/NDA approval processes.




• Knowledge of CE technical files.




• Experience with risk assessment and root cause analysis.




• Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists.




• Experience communicating with internal and external business partners and cross functional teams with various audiences.




• Experience in project management skills, with ability and proven track record to plan, manage and develop strategic initiatives to successful goal completion. Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills.




• Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates.




• Ability to influence and motivate others to drive results in a multi-location and matrixed environment.




• Position may require travel up to 10% of the time for business purposes (domestic and international).

Preferred Qualifications:

• Experience with stability studies for drugs and/or medical devices as determined by 21 CFR 211.166 and 21 CFR Part 820. 




• Knowledge in FDA recognized stability guidelines ICH Q1A(R)2 and ASTM F1980 for NDA/ANDA and medical devices, respectively.




• Experience with testing requirements for a variety medical of devices 

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$85,280.00 - $123,760.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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