Senior Technical Project Manager CMC

Provide consulting services for Sia/LBGs clients including but not limited to:

• Routinely provide strategic oversight to maintain alignment of project milestones to day-to-day activities.
• Responsible for content quality and distribution of project management deliverables (reports dashboards etc.) and routine updates (schedule budget risk) typically as the final reviewer.
• Establish strong working relationships with leadership and project functional teams across all levels.
• Serve as project spokesperson and facilitate communications with all internal and external stakeholders (meetings reports etc.).
• Work with cross-functional teams (CMC Med. Affairs/Clinical Nonclinical Quality Regulatory Finance Legal Contracts Management etc.) to drive project activities against scheduled timelines approved scope and approved budget.
• Manage project financials including vendor invoice review/approval budget development actuals tracking maintenance of time-phased financial forecast preparation of project financial reports for internal and external stakeholders.
• Proactively manage strategic risks and issues providing expertise in the identification and implementation of risk mitigation activities.
• Demonstrate and foster excellent teamwork with the ability to navigate within multidisciplinary teams.
• Balance project demands to align/realign Budget Quality Timeline and Scope as needed.
• Lead product development meetings and ensure all Project Leaders and/or subteam leaders have all the information and support needed to implement the project.
• Focus on customer service with agility and clear communication.
• Adhere to Sia/LBG quality standards regarding client deliverables.

Qualifications :

Mandatory qualifications

• 8 years of experience in the biopharmaceutical industry with a minimum of 5 years of project management experience.
• BS MS or PhD in a scientific or engineering discipline
  • E.g. Chemistry Biochemistry Chemical or Biomedical Engineering Pharmaceutical Sciences.
• Experience working with CDMOs to support outsourced development and manufacturing activities including oversight of deliverables and timelines.
• Ability to engage in technical and scientific discussions.
• Strong communication and interpersonal skills with the ability to influence collaborate and build alignment across diverse technical and leadership teams.
• Proficiency in Planisware and principles to plan manage and track multiple parallel projects in a complex matrixed environment.
• Fluent and articulate communication in English (written and spoken).
• Excellent written and oral communication presentation problem solving and negotiation skills with an emphasis on building consensus.
• Ability to work independently and in collaboration with others.
• Flexibility and ability to deal with ambiguity and sense of personal ownership of deliverables and results.
• Works well with teams often comprised of multiple disciplines.

Ideal candidates

• Comprehensive understanding of CMC including:
  • Small molecule biologics or vaccine formulation process development analytical development and GMP manufacturing across both early and late-stage development.
• Formal project management training or certification (e.g. PMP).
• Strong understanding of product development lifecycle and pharmaceutical manufacturing operations.
• Strong understanding of cGXP guidelines and regulatory requirements.

Additional Information :

Sia is an equal opportunity employer. All aspects of employment including hiring promotion remuneration or discipline are based solely on performance competence conduct or business needs. 

Remote Work :

Yes

Employment Type :

Full-time