Project Lead Position Available In Broward, Florida

Project Lead Aveva Drug Delivery Systems Inc – 3.7 Miramar, FL Job Details Full-time $70,000 – $80,000 a year 1 day ago Benefits Paid holidays Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Qualifications CGMP Microsoft Excel GLP Mid-level Master’s degree Project management lifecycle Bachelor’s degree Smartsheet Manufacturing Microsoft Project Master of Business Administration FDA regulations Product lifecycle management Stakeholder management

Full Job Description About Us:

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary:

The Project Lead will oversee and coordinate project management activities for both internal and client projects, ensuring timely delivery and successful new product launches. This role involves collaborating with clients, contract manufacturing sites, and other partners, implementing project management tools, and maintaining effective communication across departments. The Project Manager will also be responsible for establishing agreements with CMOs, selecting external labs, and ensuring the seamless execution of validation and launch batches. Regular project status updates and support for the clinical team are also key responsibilities.

Key Responsibilities:

Manage Project Management Activities :

Oversee project management tasks for both internal and client projects, ensuring all activities are aligned with project goals.

Product Lifecycle Management :

Coordinate product life cycle activities such as new vendors, materials etc. ensuring timely and successful launches for both internal and client projects.

Client and Partner Collaboration :

Work closely with clients, contract manufacturing sites, and other partners to ensure timely project delivery.

Project Management Tools Implementation :

Utilize project management tools and methodologies to track progress and identify potential risks.

Cross-Department Communication :

Facilitate effective communication with all relevant departments to ensure smooth day-to-day operations and adherence to project deadlines.

Agreement Establishment :

Establish Confidentiality Agreements and Quality Agreements with Contract Manufacturing Organizations (CMOs).

External Lab Selection :

Select and collaborate with external labs to meet project-specific needs and ensure project completion.

Project Pre-requisites Management :

Ensure the availability of all necessary project pre-requisites at each stage of the project launch.

Validation and Launch Execution :

Oversee the seamless execution of validation and launch batches at CMO sites.

Project Status Reporting :

Prepare and present regular project status updates for stakeholders, summarizing progress, issues, and risks, including meeting minutes.

Clinical Team Support :

Assist the clinical team in organizing essential documents and samples.

Education:

MBA, Masters in Pharmaceuticals Degree preferred, Bachelors degree in a STEM related field required

Work Experience:

3-5 years of relevant work experience in a cGMP manufacturing environment, preferably in pharmaceutical manufacturing Familiarity with cGMP, GLP, and regulatory guidelines like FDA, EMA, or ICH. Understanding drug product manufacturing, and product lifecycle management. Ability to lead cross-functional teams and manage diverse stakeholders. Strong verbal and written skills for effective collaboration and reporting. Analytical thinking to address challenges and implement solutions. Flexibility to navigate dynamic project requirements and industry changes. Proficiency with standard tools such as Excel, MS Projects, Smartsheet etc.

Benefits:

Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan Medical/Dental/Vision Insurance Paid Time Off 401k with employer match Paid Holidays and Floating Holiday Equal Opportunity Employer