Job Description
Job Description
Job Title: CMC Project Manager
Location: Cambridge, MA. - 02142
3+ YEARS OF EXPERIENCE IN CMC (CHEMISTRY, MANUFACTURING, AND CONTROLS) PROJECT MANAGER
CANDIDATE WHO ARE WILLING TO RELOCATE TO CAMBRIDGE, MA. WILL ALSO WORK.
Top 3 Must-Have Skills/Experience:
Project Management experience
Strong communication skills (engage across all levels throughout the workday)
Multitasking and ability to work both independently and in teams
Nice-to-Haves:
Experience in early or late-stage development
Familiarity with evolving process documentation/templates
Minimum Years of Experience:
3–5 years required
Open to candidates with more experience
Education/Certifications:
Bachelor’s Degree required (Life Sciences or Engineering preferred)
Tools/Technologies Used:
Smartsheet (Intermediate level, ~3 years of experience ideal)
Soft Skills/Traits Desired:
Highly organized
Proactive communicator
Able to adapt to changes in process and systems
Day-to-Day Responsibilities
Update project timelines regularly
Follow up on missing information and drive updates
Use Smartsheet to manage and adapt templates to evolving processes
Manager, CMC Project Management (Contract)
Cambridge, Hybrid
Summary of Key Responsibilities
· Management of project plans and timelines for the completion of all ongoing CMC activities (Chemistry, Manufacturing, and Controls) required to support Life Cycle Management of Commercial programs
· Work together with Commercial CMC leads and expertise areas (Regulatory Affairs, Manufacturing, Manufacturing Operations Support, Process Sciences, Supply Chain and Quality) to establish/update project plans including risk mitigations for the Technical Operations and Quality Organization
· Support Early-Stage programs by updating ES/Development CMC templates in Smart Sheet to stay current with the changes in the process
· Collaborate with CMC PMs and leads on improvement of project plans including resources and risk mitigations for the Technical Operations
· Prepare and present project improvements to CMC PM team
Qualifications
· Bachelor’s degree is required. Degree in life sciences/engineering is strongly preferred
· 3-5 years of development and/or project management experience within the biopharmaceutical or pharmaceutical industry
· Experience with different stages of CMC development (Early stage (Ph I/II clinical trials) and Late/Commercial) preferred
· Experience working with MS Office Suite (Excel, Word, PowerPoint) and Smart Sheet
· Highly motivated and flexible, with excellent organizational, time and project management skills
· Strong interpersonal and communication skills
· Ability to work independently and as part of a multi-disciplinary team
Company DescriptionIT Mantra, LLC. is a Certified Woman / Minority (WBE/MBE) owned company founded in 2003 and based in Massachusetts. We provide a comprehensive range of IT and Professional Staffing and Workforce Solutions that include contract, contract to hire and direct hire placement services as well Employer of Record (EOR) services nationally and specialize in the placement of women and diverse personnel.
Company Description
IT Mantra, LLC. is a Certified Woman / Minority (WBE/MBE) owned company founded in 2003 and based in Massachusetts. We provide a comprehensive range of IT and Professional Staffing and Workforce Solutions that include contract, contract to hire and direct hire placement services as well Employer of Record (EOR) services nationally and specialize in the placement of women and diverse personnel.