CMC Technical Senior Project Manager

Job description

The CMC (Chemistry, Manufacturing, and Controls) Technical Senior Project Manager provides operational management for CMC development and technical transfer projects.

Working in close partnership with the CMC Program Manager - who drives program-level strategy and communications - the Senior Project Manager leverages their technical and project management expertise to serve as the operational hub for CMC project teams, driving execution, communication, and accountability across process development, analytical, formulation, quality, and supply chain, as well as external partners.

This role blends technical understanding of biopharmaceutical CMC development disciplines with strong 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 a deep understanding of CMC development.

Responsibilities:

Providing consulting services for Sia’s clients in the life sciences and healthcare industries, including but not limited to:

• Provide strategic oversight to maintain alignment of project milestones with day-to-day activities.
• Responsibility 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 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 a sense of personal ownership of deliverables and results.
• Works well with teams, often comprised of multiple disciplines.

Ideal qualifications:

• 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

Why join the Sia Village?

Excellence | Entrepreneurship | Innovation | Teamwork | Care & Support | Employee Wellbeing

These are the six core values that guide all our actions.

Your experience at Sia will be enriched by a(n):

• Entrepreneurial journey
• Support with achieving professional development goals through guidance and real-time feedback
• Continuous learning & development opportunities

All your information will be kept confidential according to EEO guidelines.

Sia Partners 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.

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.