CMC Project Manager

Randstad
Waltham, MA Full Time
POSTED ON 8/2/2023 CLOSED ON 8/4/2023

What are the responsibilities and job description for the CMC Project Manager position at Randstad?

job summary:
The CMC Project Manager will be responsible for project management functions within the mRNA Center of Excellence, primarily focused on management of Chemistry, Manufacturing and Controls (CMC) activities for preclinical through early-stage (Ph1) development programs. The ideal candidate will have significant relevant experience and a track record of accomplishments in the life sciences/ pharmaceutical/biotechnology industry.

The CMC Project Manager will support the CMC subteam composed of cross-functional representatives from within and external to the mRNA CoE.

The successful candidate is expected to have a technical background (6 years of industry experience) in formulation development, process engineering, or chemistry with additional industry experience in project/program management in the pharmaceutical or biotech field developing clinical and commercial candidates.

As the world's 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: Waltham, Massachusetts
job type: Contract
salary: $75.00 - 82.39 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Support the CMC Leader in leading cross-functional CMC subteams to develop and execute the CMC strategy for development projects from pre-clinical through early stage (Ph1).
  • Collaborate with multi-disciplinary team members to analyze/optimize development approaches and to develop detailed integrated operational project plans to achieve the project milestones. Ensure alignment of the CMC project plan with the Global project plan. Support resource planning and allocation (i.e. via Planisware) and cost planning activities.
  • Apply project management expertise and best practices in the planning, initiation, execution and tracking of project activities.
  • Lead regularly scheduled CMC subteam meetings to track activities, monitor progress, drive decision making, resolve issues, and identify/track risks and mitigation plans. Facilitate meetings through issuance of meeting agendas and minutes and tracking/follow up of action items.
  • Manage project budget and track expenses.
  • Serve as Scrum Master and organize/drive project sprints to achieve key deliverables. This includes backlog preparation, sprint planning, scrum meeting and retrospectives facilitation.
  • Proactively monitor project progress and provide timely communications to the mRNA CoE Leadership Team, to the Global Project Team and to other key stakeholders regarding project status, critical path activities, resource requirements, and risks and mitigation strategies.
  • Support functional workstream leaders and team members when required to enhance performance/execution of critical activities.
  • Own and manage information sharing platform (i.e. Teams/Sharepoint) for CMC-Subteam.
  • Participate in the development, implementation, and sustainability of standard project management tools and best practices within the mRNA CoE Global PMO.
 
qualifications:
  • 6 years of relevant experience in the biopharmaceutical industry.
  • College or advanced degree in chemical, biomedical, biochemical, or process engineering, chemistry, materials sciences, or formulation sciences.
  • Knowledge of typical CMC activities and requirements.
  • Demonstrated success in managing multiple projects effectively and using project management tools.
  • Excellent organizational skills with great attention to detail.
  • PMP certification is a plus.
  • Knowledge of and experience with implementing Agile/Scrum methodologies is a plus.
  • Strong interpersonal skills, self-awareness and ability to manage team dynamics.
  • Strong written and oral communication skills, with demonstrated experience managing cross-functional communication.
  • Excellent presentation skills and comfortable presenting to leadership and other key stakeholders.
  • Strong and collaborative work ethic. Results oriented and demonstrates a focus on achieving (business) results.
  • Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
  • Knowledge and understanding of laboratory terminology, good documentation, and good laboratory practices.
  • Experience and demonstrated proficiency in global GxPs, industry guidance (esp., ICH Q6 - Q12) and compliance with the same.
  • Excellent knowledge with all aspects of MS Office including MS Project and Visio, Sharepoint and MS Teams.
 
skills: CMC, MS-WORD, MS-EXCEL, MS-Powerpoint, Chemistry, PMP

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).



For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

Salary : $75 - $0

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