Senior Project Manager

3 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Corporation Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 5+ years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
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.

Description:

  • This role will support the External Supply Operations organization by leading NPIs and coordinating product transfers into the external manufacturing network, as well as advancing systems and processes related to Site Selections, Launches, and Technical Transfer Management.
  • This person will lead efforts that focus on joint team engagements, identifying and delivering on key project milestones, integrate external supplier functions with company processes, provide recommendations to drive pivotal initiatives, business performance and operational improvements.
  • The Manager is responsible to stay informed of standard methodologies and provide innovative, impactful ideas to optimize processes to support the organization's growth strategies.
The successful candidate will lead multiple NPIs, projects and initiatives that advance External Supply Operations strategies, goals and objectives. Specific responsibilities include:
  • Responsible for leading new product introduction activities for new launches or programs tech transferring into CMOs.
  • Provide project strategic direction of external manufacturing technical transfer and new product introduction activities coordinating execution of cross-functional workstreams from Quality, Process Development, Contracts, Supply Chain, Analytical Sciences and Global Strategic Sourcing.
  • Execution and adherence to PSM NPI business processes and operating model.
  • Strong interpersonal skills as interactions will be both internal and external facing with CMOs and Executive leadership.
  • Lead multiple cross-functional projects of medium to high complexity.
  • Build and maintain project plans and team assignments using project planning tools, estimating project cost and adhering to budget, directing and supervising work efforts on daily basis, identifying resource needs, performing project reviews, and advancing functional, quality, timeline and cost issues appropriately.
  • Understand and react to project risks, scope changes, industry trends and influences.
  • Utilize project management processes, software and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.
  • Handle communication with all areas of the enterprise that impact scope, budget, risk and resources of the work being managed and provide project updates and reporting to executive leadership and internal partners.
  • Lead continuous improvement projects that deliver measurable gain in quality, efficiency and alignment within **** priorities.
  • Apply the knowledge, skills, tools of project management and operational perfection to ensure efficient execution of projects and continuous improvement initiatives.
Requirements

Basic Qualifications:

  • Doctorate degree OR Master's degree and 2 years of solid experience within a cGMP manufacturing or quality environment OR Bachelor's degree and 4 years of solid experience within a cGMP manufacturing or quality environment OR Associate's degree and 10 years of solid experience within a cGMP manufacturing or quality environment OR High school diploma / GED and 12 years of solid experience within a cGMP manufacturing or quality environment
Preferred Qualifications:
  • Strong organizational and cross-functional project management skills.
  • Strong technical background with understanding of pharmaceutical manufacture and commercialization.
  • High ethical business standards, fosters inclusivity and promotes diversity.
  • Demonstrated accountability to deliver results and meet deadlines while handling contending priorities.
  • Problem-solving, critical thinking and decision-making skills.
  • Strong interpersonal, listening and customer service skills.
  • Strong presentation abilities, oral and written, including confidence and decisiveness when engaging with Senior Management and customers.
  • Experience managing and influencing in a matrix organization.
  • Manufacturing and cGMP knowledge and experience.
  • Operational Excellence proficiency.
  • Understanding of contractual requirements.
  • Technical writing and multi-level presentation skills.
  • Experience leading effectively in collaborative team environment.
  • Ability to take initiative, drive action and work under minimum supervision.
  • Proficiency in Microsoft Office especially Project, Excel, PowerPoint, Visio, Smartsheet and ThinkCell.
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