Technical Project Manager CMC

The CMC Technical Project Manager provides day-to-day operational management for CMC development and technical transfer projects. Working in close partnership with the CMC Technical Senior Project Manager who leads project management activities the CMC Technical Project Manager leverages their technical and project management expertise to serve as the operational hub for CMC project teams supporting execution and communication across process development analytical formulation quality supply chain and external partners.

This role blends technical understanding of biopharmaceutical CMC development disciplines with project management and coordination skills. Candidates are required to have biopharmaceutical industry experience through CMC technical roles with project management responsibility or through project management roles with understanding of CMC development.

Responsibilities

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

• Routinely provide tactical support for day-to-day project activities such as meeting minutes action tracking/follow-up decision tracking etc.
• Actively contribute to project management deliverables (reports dashboards etc.) and routine updates (schedule budget risk) typically preparing initial drafts.
• Build and maintain detailed predecessor-driven project schedules (Gantt charts integrated timelines) utilizing scheduling tools/software (e.g. MS Project Smartsheet Planisware Primavera or equivalent).
• Provide clear and timely schedule updates variance analyses and risk assessments to project leaders and stakeholders to ensure project schedules remain aligned with project strategy portfolio priorities and key decision gates (e.g. regulatory submissions health authority interactions).
• Coordinate across project functional areas and personnel as required to ensure progress of project activities.
• Support the building and management of a team representing various functions and sites including the management of multiple projects and teams across multiple locations.
• Demonstrate and foster excellent teamwork with the ability to navigate within multidisciplinary teams.
• Balance project demands to support alignment/realignment of Budget Quality Timeline and Scope as needed.
• Support product development meetings and make sure all Project Leaders and/or subteam leaders have all 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

• At least 2 years of experience in the biopharmaceutical industry with a minimum of 1 year 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.
• Good communication and interpersonal skills.
• Proficiency in Planisware.
• Fluent and articulate communication in English (written and spoken)
• Good written and oral communication presentation problem solving and negotiation skills.
• Ability to work independently and in collaboration with others.
• Flexibility and ability to deal with ambiguity and a strong sense of personal ownership of deliverables and results.
• Works well with teams often comprised of multiple disciplines.

Desirable Qualifications

• Broad 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).
• Understanding of product development lifecycle and pharmaceutical manufacturing operations.
• 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