Technical Senior Project Manager - CMC

Job description

Company Description Sia is a next-generation, global management consulting group born digital, augmented by data, enhanced by creativity, and driven by responsibility. We partner with clients to resolve challenges and capitalize on opportunities. We believe that in today’s world of change and disruption, optimism is a force multiplier. Sia’s Life Science and Healthcare Business Unit, Sia/LBG, focuses on supporting the life sciences and healthcare industries with strategic consulting, product development and non-dilutive funding expertise. This consulting division works with healthcare organizations, pharmaceutical & biotech companies, CROs, academia, medical device/diagnostic companies, and non-governmental organizations (NGOs) alike to solve complex business, scientific, regulatory, technological and product development challenges. Our subject matter experts help advance our clients’ products and projects; supporting these companies - both large and small - to achieve organizational objectives and create tangible value for their stakeholders. 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 Job Description The CMC 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 deep understanding of CMC development. Responsibilities Provide consulting services for Sia/LBG’s 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 o 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. Desirable 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 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.