Senior Project Manager – Process Development

1 month ago

Dublin, Ireland PSC Biotech Ltd Full time
Job Description
About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. 

Senior Project Manager – Process Development

 

Overview:

The Snr Project Manager – Process Development will report to the Sr. Manager Process Development in the Portfolio Management and Delivery (PMD) group and will be responsible for managing new product introduction and lifecycle management projects for drug product (DP) and finished drug products (FDP). The successful candidate will have at least five to eight years of experience within the pharmaceutical or biotech industry and will have demonstrated project management skills.



Requirements

The ideal candidate will have:

  • Experience in a leadership role in a pharmaceutical or biotech manufacturing facility that engages with site SMEs and managers, and global functions
  • The ability to influence and lead cross functional teams to deliver to ensure the smooth introduction of new products and the health of existing products
  • The ability to work independently and identify risks and mitigation pathways for new and existing products
  • A passion for continuous improvement applied to product and program leadership

 

Scope of Role:

  • Arrange agreement among the project team, customers, and management on the goals of the project
  • Develops and maintains the Project schedule/plan that addresses quality, objective, scope, cost, schedule, resources, and responsibilities - to deliver the project, and measure progress against schedule and budget
  • Effectively communicate with everyone involved in the project
  • Have a controlled scope in place, that is understood by all stakeholders and maintained throughout completion of the project
  • Execute prudent risk and issue management.
  • Maintains Actions/Risk and Decision logs
  • Generates and owns the GMP change control.
  • Motivate, support and direct project team members to deliver on project plan.
  • Leads Team meetings and cross functional collaboration
  • Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time

Compliance Related Tasks:

  • Always ensure compliance to cGMP
  • Ensure safety & compliance standards are maintained to the highest standards
  • Ensure financial compliance in line with Business & Financial guidance
  • Support a culture of personal responsibility within reporting structure

 

Skills & Knowledge:

  • High Energy and Commitment
  • Ability to work independently
  • Comfortable leading across multiple stakeholders & multinational teams
  • Strong ability to influence and affect change
  • Capable of resolving issues of conflict effectively
  • Strong communicator
  • A proven track record in the ability to transfer goals and objectives into measurable plans
  • Ability to identify gaps/risks and put appropriate remediation plans in place
  • Uses strong relationships to identify requirements and potential opportunities
  • Employs project management techniques and Problem Solving
  • Provides leadership, guidance, and advice in own field of project management

 

Qualifications and Experience:

  • Technical Degree and/or Masters’ or equivalent
  • 5-8 years of experience (including min of 3yrs as Project Manager) in a Life Science / Pharmaceutical / Biotechnology Environment
  • Preferred Experience: Portfolio Management, Portfolio Resource Management, Business Case Development

 

Systems / Equipment:

  • Smartsheet, MS Office, MS Project, MS PowerPoint and MS Visio. 
  • Trackwise Change Control & Document Management Systems


Requirements
The ideal candidate will have: Experience in a leadership role in a pharmaceutical or biotech manufacturing facility that engages with site SMEs and managers, and global functions The ability to influence and lead cross functional teams to deliver to ensure the smooth introduction of new products and the health of existing products The ability to work independently and identify risks and mitigation pathways for new and existing products A passion for continuous improvement applied to product and program leadership Scope of Role: Arrange agreement among the project team, customers, and management on the goals of the project Develops and maintains the Project schedule/plan that addresses quality, objective, scope, cost, schedule, resources, and responsibilities - to deliver the project, and measure progress against schedule and budget Effectively communicate with everyone involved in the project Have a controlled scope in place, that is understood by all stakeholders and maintained throughout completion of the project Execute prudent risk and issue management. Maintains Actions/Risk and Decision logs Generates and owns the GMP change control. Motivate, support and direct project team members to deliver on project plan. Leads Team meetings and cross functional collaboration Works with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time Compliance Related Tasks: Always ensure compliance to cGMP Ensure safety & compliance standards are maintained to the highest standards Ensure financial compliance in line with Business & Financial guidance Support a culture of personal responsibility within reporting structure Skills & Knowledge: High Energy and Commitment Ability to work independently Comfortable leading across multiple stakeholders & multinational teams Strong ability to influence and affect change Capable of resolving issues of conflict effectively Strong communicator A proven track record in the ability to transfer goals and objectives into measurable plans Ability to identify gaps/risks and put appropriate remediation plans in place Uses strong relationships to identify requirements and potential opportunities Employs project management techniques and Problem Solving Provides leadership, guidance, and advice in own field of project management Qualifications and Experience: Technical Degree and/or Masters’ or equivalent 5-8 years of experience (including min of 3yrs as Project Manager) in a Life Science / Pharmaceutical / Biotechnology Environment Preferred Experience: Portfolio Management, Portfolio Resource Management, Business Case Development Systems / Equipment: Smartsheet, MS Office, MS Project, MS PowerPoint and MS Visio. Trackwise Change Control & Document Management Systems

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