CMC Project Manager - Pharmaceutical Development

Job Summary

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

location: Cambridge, Massachusetts

job type: Contract

salary: $65.00 - 68.97 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

• Project Management & Coordination:
• Manage CMC development and Pharmaceutical Technical activities for new R&D compounds, Life Cycle Management Programs (LCM), product expansions, and industrial technical projects.
• Develop and maintain project scope documents, timelines, and detailed project plans with milestones.
• Organize and lead project meetings with cross-functional teams, sponsors, and stakeholders.
• Conduct risk assessments and develop contingency plans for project activities.
• Technical Leadership & Support:
• Implement product control strategies and support process lifecycle management.
• Provide technical support to manufacturing sites for significant deviations and drive improvements in process robustness and yields.
• Assist with the review and finalization of technical documents, including protocols, reports, and regulatory dossier content.
• Select and apply Quality by Design (QbD) strategies, process parameter risk assessments, and prior knowledge applications.
• Collaboration & Communication:
• Work closely with MSAT CMC Leaders, Manufacturing & Supply (M&S) teams, Regulatory, R&D, and external CMOs to align project goals.
• Prepare and deliver project updates to sponsors and senior management.
• Summarize proposals from CMOs/CROs and present recommendations for approval.
• Assist in reviewing contracts (CDSs, MSAs, Quality Agreements) to support development and industrial projects.
  

Qualifications

Must-Haves:

• Education: BS/MS in Chemistry, Pharmacy, or a related scientific field.
• Experience: At least 7 years in technical project management, pharmaceutical development, technical operations, and/or manufacturing of drug product dosage forms.
• Project Management Skills:
• Prior experience managing technical projects with multi-disciplinary teams.
• Ability to create and maintain project plans, timelines, and risk assessments.
• Experience organizing meetings and communicating project updates with stakeholders.
• Technical Expertise:
• Experience implementing product control strategies.
• Knowledge of QbD strategies, process risk assessments, and life-cycle management.
• Experience working with MSAT, CMC, and Manufacturing & Supply (M&S) programs.
• Regulatory & Quality Knowledge: Understanding of pharmaceutical GMP, regulatory compliance, and deviation management.
• Communication & Organizational Skills: Strong writing, presentation, and stakeholder communication skills.
• Software Proficiency: MS Office and project management tools.
• Onsite Requirement: Must be fully onsite in Cambridge, MA.
• Travel: Open to travel up to 20%.
• Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.
  

Nice-to-Haves

• MBA or Advanced Degree in a relevant field.
• Experience with International Project Teams.
• Regulatory or Quality Background (highly desirable).
• French Language Proficiency (speaking, reading, or writing).
• Experience Working with CMOs/CROs and reviewing contracts like MSAs and Quality Agreements.
  
  

skills: Project Management, CMC, Quality control, MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint, Chemistry, GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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