CMC技术项目经理
CMC Technical Project Manager
CMC（化学、制造和控制）技术项目经理负责CMC开发和技术转移项目的日常运营管理。
与CMC技术高级项目经理（负责项目管理活动）紧密合作，CMC技术项目经理利用其技术和项目管理专业知识，作为CMC项目团队的运营中心，支持流程开发、分析、配方、质量、供应链和外部合作伙伴之间的执行和沟通。
该职位结合了生物制药CMC开发领域的技术理解与项目管理和协调技能。
候选人需要通过CMC技术岗位或具有项目管理职责的岗位，在生物制药行业有相关经验，或者通过项目管理岗位并具备CMC开发的理解。
职责：
为Sia的客户提供生命科学和医疗行业的咨询服务，包括但不限于：
- 为日常项目活动提供战术支持，如会议纪要、行动项跟踪/跟进、决策跟踪等。
- 积极参与项目管理交付物（报告、仪表盘等）和常规更新（进度、预算、风险），通常负责初稿的编写。
- 利用调度工具/软件（如MS Project、Smartsheet、Planisware、Primavera或同等工具）构建和维护详细的前置任务驱动项目计划（甘特图、整合时间线）。
- 向项目经理和相关方提供清晰及时的进度更新、偏差分析和风险评估，确保项目进度与项目策略、组合优先级和关键决策节点（如监管提交、卫生当局互动）保持一致。
- 根据需要在项目职能领域和人员之间进行协调，以确保项目活动的进展。
- 支持建立和管理代表不同职能和地点的团队，包括跨多个地点管理多个项目和团队。
- 展示并促进良好的团队合作，能够在一个多学科团队中有效运作。
- 平衡项目需求，根据需要支持预算、质量、时间表和范围的对齐/重新对齐。
- 支持产品开发会议，并确保所有项目经理和/或子团队负责人了解相关情况。
查看英文原文
The CMC (Chemistry, Manufacturing, and Controls)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 an 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 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 the 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 quality standards regarding client deliverables.
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.
Ideal 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.
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 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 Unitfocuses 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.
Originally posted on Himalayas