Michael D. Birnbaum
Largo,FL
Summary
Results-driven project management professional with proven ability to lead teams and drive successful project outcomes. Adept at balancing multiple priorities, ensuring effective communication, and delivering on project goals in dynamic environments. Expertise in project planning, risk management, and stakeholder engagement. Known for adaptability, reliability, and strong focus on collaboration and achieving results.
Overview
29
29
years of professional experience
Work History
Associate Project Manager
Catalent Pharma Solutions
St. Petersburg, Florida
02.2021 - Current
- R&D project manager focusing on early to mid-phase drug development (cGMP and non-cGMP environment)
- Current workload is 12+ projects inclusive of tech transfers, analytical method development, stability, registration, confirmation batch process validation/commercialization and clinical supplies
- Drive project strategy decisions with senior leadership teams; demonstrating an ability to influence at multiple levels.
- Use standardized organizational tools, systems and techniques for tracking project progress, maintain current project Gantt charts and task lists.
- Partner with CMC Regulatory, Quality and Technical leads to define and manage plans and timelines for the completion of all activities required to prepare and support CMC related sections for regulatory submissions.
- Coordinate the scheduling of importing and exporting of clinical batch products for finished product packaging.
- Support Customers with IND, NDA. ANDA filings as well as DMF's
- Prevent and resolve operational issues such as deviations, corrective and preventative actions, production delays.
- Support of departmental training and in the preparation of training documents
- Compliance with the harmonized rules of the Catalent Customer Service Excellence Matrix Organization
- Monitoring of internal milestones and key performance indicators
- Preparation of the monthly and quarterly financial forecast
- Support of client service and business development in customer service, quotation preparation and billing questions
- Provide support to Vendor Management Operations to enable prioritization of activities supporting novel engagements.
- Independently coordinate and lead global, cross-functional project teams in a matrix organization with minimal guidance from the Program Manager. Some assignments may include projects of greater complexity.
Project Manager
Formulated Solutions
Largo, Florida
12.2019 - 06.2020
- Lead R&D product reformulation and packaging development projects in cGMP and Non-GMP environments.
- Pharmaceutical manufacturing of personal care products (PCP), OTC, medical device and Rx products.
- Presents project status reports to executive leadership and sr. level management.
- Primary point-of-contact for key leaders and stakeholders across multiple business units.
- Lead planning and implementation of highly regulated projects across large matrix environments as well as being responsible for all program KPI's
- Facilitate the definition of project scope, gap analysis, goals, risk mitigation and deliverables.
- Define project tasks and resource allocation using LOI's and expedited PO's
- Organize and lead team meetings with detailed agendas, clearly documenting meeting minutes, action items, issues, risks and decisions.
- Manage sourcing of API'S and billing of materials (BOM's) for all projects
- Help maintain patent project supply chain and procurement relationships
- Reference and take involvement in company (Regulatory) deviations, corrective and preventive actions (CAPAs), and risk assessments as it relates to document control procedures.
- Plan, track, and schedule project timelines utilizing project management tools and methodologies
- Work with quality & regulatory teams to ensure cGMP compliancy & quality assurance
- Defines and maintain standards for project management within the organization.
- Track and maintain metrics
- Ensure that manufacturing stays on schedule and within budget.
- Coordinate manufacturing with R&D, Engineering, Procurement, and Regulatory/Quality stakeholders, as well as with vendors and shippers.
- Direct, lead and motivate multi-disciplinary project teams and hold team members accountable to deliver results within an agreed project governance structure to ensure customer satisfaction throughout the life of the program.
R&D Contract Management Associate (Project Mgmt. Role)
Bristol-Myers Squibb Company
Tampa, FL
08.2015 - 01.2019
- Project management position averaging 6-12 projects running concurrently (internal & external logistics) contracting healthcare consultants on a global landscape (EU, India, South America)
- Provide legal support and administration covering a broad spectrum of support to R&D regulatory, compliance, quality, pharmacovigilance, business development, and medical affairs and medical information.
- Early phase asset/project experience (clinical trials, CRO's, medical congresses, advisory boards, long-term studies, publications, medical affairs)
- Review and draft a broad range of legal agreements (MSA's, CSA's, CDA's, SOW's, CTA's, ICF's) for HCP's along with due diligence, for healthcare, non-healthcare consultants, institutions and CRO's worldwide (EMEA)
- Negotiate contract terms and conditions with sites/investigators/institutions.
- Works extensively and collaboratively with international colleagues with respect to contract alignment, local regulatory, compliance and disclosure requirements
- Refined the assembling and acquisition of project brief approvals while monitoring in-house stakeholder management and expectations.
- Experienced project mgmt. skills required to coordinate multiple logistic/vendor partners through the process.
- Oversaw fund and payment creation process.
- Managed project finances by using influencing and leadership skills to gain alignment with senior finance project managers.
- Interfaced daily with R&D senior mgmt./ leadership coordinating both legal and functional project aspects.
- Participated in implementing quarterly training programs.
- Experience working across multiple cross functional teams in clinical research (i.e. CRO, site management organization, corporate lines of business, outcomes research, etc.
- Thorough knowledge of transparency guidelines (The Sunshine Act) including an in-depth knowledge of both regulatory and compliance requirements domestically and internationally.
Chemical Engineer Internship
Case Western Reserve University
Cleveland, OH
05.1996 - 08.1996
- Worked on the development of chemical and biomedical sensors for single use, cost effective measurements.
Education
Associate of Science - Nursing (RN)
St. Petersburg College
St. Petersburg, FL07.2024
MBA - Project Management & Healthcare Management
Saint Leo Univ.
San Antonio, FL06.2016
B.A.Sc. - Health Service Administration
St . Petersburg College
St. Petersburg05.2012
Associate of Science - Nuclear Medicine Technoilogy
Hillsborough Community College
Tampa, FL07-2008
It Platform Skills
- Work Front
- Vizio
- Quick Base
- Oracle JDE
- MS Project 2016
- SAP
- Navision
- MS Access
- MS Excel
- Workday
- Linux
- Ariba
- SQL
- Veeva
- Eclipse
- Certify
- CAP
- Citrix platforms
- Navigator
- IView
- Regulus
- Enroll D
- IDX
- DPAS
- WEQ
- MS Outlook
- MS Power Point
- Q-NXT
- SharePoint
Timeline
Associate Project Manager
Catalent Pharma Solutions
02.2021 - Current
Project Manager
Formulated Solutions
12.2019 - 06.2020
R&D Contract Management Associate (Project Mgmt. Role)
Bristol-Myers Squibb Company
08.2015 - 01.2019
Chemical Engineer Internship
Case Western Reserve University
05.1996 - 08.1996
Associate of Science - Nursing (RN)
St. Petersburg College
MBA - Project Management & Healthcare Management
Saint Leo Univ.
B.A.Sc. - Health Service Administration
St . Petersburg College
Associate of Science - Nuclear Medicine Technoilogy
Hillsborough Community College
Similar Profiles
Deanna PenyakDeanna Penyak
Executive Administrative Specialist at Catalent Pharma SolutionsExecutive Administrative Specialist at Catalent Pharma Solutions
Steven WilliamsonSteven Williamson
Supervisor at Catalent Pharma SolutionsSupervisor at Catalent Pharma Solutions
Shane TrotmanShane Trotman
Process Development Intern at Catalent Pharma SolutionsProcess Development Intern at Catalent Pharma Solutions
Ashley NormanAshley Norman
Interim Microbiology Manager at Catalent Pharma SolutionsInterim Microbiology Manager at Catalent Pharma Solutions
Bruce ClamentBruce Clament
Lead Service Technician at BERCO (Beverage Equipment Repair Company)Lead Service Technician at BERCO (Beverage Equipment Repair Company)