Stability Manager- Research and Development

1 month ago

Mundelein, United States Medline Industries, Inc. Full time

JOB SUMMARY:

Manage Research and Development (R&D) function and resources for all aspects of the Medline Laboratories stability program in support of the development of Medline new and existing products.

MAJOR RESPONSIBILITIES:

* Manage stability related activities and accountability of the team to ensure program compliance to current laboratory, regulatory, safety and environmental guidelines as it relates to the stability process and sample conditioning.
* Generate, evaluate and present various stability performance metrics on a quarterly basis.
* Manage stability study portfolio through use of LIMS and to provide stability data trend analysis based on organizational needs.
* Oversee equipment adequacy, functionality and preventative maintenance in support of current and future product conditioning requirements
* Collaborate with divisional personnel, quality, regulatory, legal, and manufacturers to identify projects and new product initiatives, develop timelines, identify necessary resources, advise on product stability and establish clear lines of communication to ensure successful execution.
* Identify issues and risks that might delay a project and make recommendations or develop contingency plans.
* Evaluate new technologies and products. Remain up-to-date with new developments in the field, nationally and internationally, and incorporate as required.
* Research, plan, and implement new products, programs, and/or protocols.
* Management responsibilities include:
* Day-to-day operations of a group of employees.
* May have limited budgetary responsibility and usually contributes to budgetary impact;
* Interpret and execute policies for departments/projects and develops.
* Recommend and implement new policies or modifications to existing policies.
* Provide general guidelines and parameters for staff functioning.
* Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.



Education

* Bachelor's degree in Chemistry, Biology or related science field.

Work Experience

* A least 4 years of experience in a medical device or pharmaceutical related field.
* Experience in the indirect management of team members, including assisting in the development, training and assignment of work/projects to other members of a team.
* Experience assessing and initiating actions independently. Experience taking charge of a situation, team or project.
* Experience processing all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.
* Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.

PREFERRED JOB REQUIREMENTS

* At least 5 years of R&D experience in the healthcare industry.
* Experience in stability for drugs and/or medical devices as determined by 21 CFR Part 166 and 21 CFR Part 820.

Knowledge in FDA recognized stability guidelines ICHQ1A(R)2 and ASTMF1980 for NDA/ANDA and medical devices respectively.

Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
* Experience supervising and leading cross-functional teams.
* Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.

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