CMC Technical Senior Project Manager

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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 Life Science and Healthcare Business Unit focuses on supporting Sia's clients in 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.

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.

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.

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.

Sia是一家新一代全球管理咨询集团，生而数字化，以数据增强，以创造力提升，以责任驱动。我们与客户携手合作，解决挑战并把握机遇。我们相信，在当今变革与颠覆的世界中，乐观是一种力量倍增器。

Sia生命科学与医疗健康业务部门专注于通过战略咨询、产品开发和非稀释性资金专业知识，支持Sia在生命科学和医疗健康行业的客户。

该咨询部门与医疗健康组织、制药与生物技术公司、CRO、学术机构、医疗器械/诊断公司以及非政府组织（NGO）等合作，解决复杂的商业、科学、监管、技术和产品开发挑战。

我们的主题专家帮助推进客户的产品和项目，支持这些公司——无论规模大小——实现组织目标并为利益相关方创造切实价值。

CMC（化学、制造和控制）技术高级项目经理为CMC开发和技术转移项目提供运营管理。
高级项目经理与CMC项目经理——负责推动项目级战略和沟通——紧密合作，利用其技术和项目管理专业知识，担任CMC项目团队的运营枢纽，推动工艺开发、分析、制剂、质量、供应链以及外部合作伙伴的执行、沟通和问责。
该角色融合了对生物制药CMC开发学科的技术理解与强大的项目管理和协调能力。
候选人需具备生物制药行业经验，曾担任CMC技术角色并承担项目管理职责，或曾担任项目管理角色并对CMC开发有深入理解。

职责：
为Sia在生命科学和医疗健康行业的客户提供咨询服务，包括但不限于：
提供战略监督，确保项目里程碑与日常活动保持一致。
负责项目管理交付物（报告、仪表板等）和常规更新（进度、预算、风险）的内容、质量和分发，通常作为最终审核人。
与各层级领导和项目职能团队建立牢固的工作关系。
担任项目发言人，促进与所有内部和外部利益相关方的沟通（会议、报告等）。
与跨职能团队（CMC、医学事务/临床、非临床、质量、法规、财务、法务、合同管理等）合作，按照计划时间表、批准的范围和批准的预算推动项目活动。
管理项目财务，包括供应商发票审核/批准、预算编制、实际支出跟踪、时间分段财务预测维护、为内部和外部利益相关方准备项目财务报告。
主动管理战略风险和问题，在识别和实施风险缓解活动方面提供专业知识。
展示并培养卓越的团队合作精神，具备在多学科团队中导航的能力。
根据需要平衡项目需求，使预算、质量、时间表和范围保持一致/重新对齐。
主持产品开发会议，确保所有项目负责人和/或子团队负责人拥有实施项目所需的所有信息和支持。
专注于客户服务，具备敏捷性和清晰的沟通能力。
遵守Sia关于客户交付物的质量标准。

必备资格：
8年以上生物制药行业经验，至少5年项目管理经验。
科学或工程学科（如化学、生物化学、化学或生物医学工程、药学）的学士、硕士或博士学位。
具有与CDMO合作支持外包开发和制造活动的经验，包括对交付物和时间表的监督。
能够参与技术和科学讨论。
强大的沟通和人际交往能力，能够影响、协作并在多元化的技术和领导团队中建立一致性。
熟练使用Planisware及其原则，能够在复杂的矩阵环境中规划、管理和跟踪多个并行项目。
流利且清晰的中英文沟通能力（书面和口头）。——此处原文为“Fluent and articulate communication in English (written and spoken)”，应译为：流利且清晰的英语沟通能力（书面和口头）。
出色的书面和口头沟通、演示、问题解决和谈判能力，注重建立共识。
能够独立工作并与他人协作。
具备灵活性和处理模糊性的能力，以及个人对交付物和结果的主人翁意识。
善于与团队合作，团队通常由多个学科组成。

理想资格：
对CMC有全面的理解，包括：小分子、生物制品或疫苗制剂、工艺开发、分析开发和GMP生产，涵盖早期和后期开发。
正式的项目管理培训或认证（如PMP）。
对产品开发生命周期和制药制造运营有深入理解。
对cGXP指南和法规要求有深入理解。

为什么加入Sia Village？
卓越 | 创业精神 | 创新 | 团队合作 | 关怀与支持 | 员工福祉
这是指导我们所有行动的六项核心价值观。
您在Sia的经历将通过以下方面得到丰富：
创业之旅
通过指导和实时反馈支持实现职业发展目标
持续学习和发展的机会
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