Project Manager, CMC

We currently seek a CMC Project Manager (PM) with proven experience in CMC project management. As a key member of our CMC teams, the CMC PM will work collaboratively with CMC Team Leaders and the CMC Team to drive the definition of our CMC strategy, and provide team support through all product development stages (Process and Analytical Development, Process Transfer, GMP Manufacturing and Testing, Process and Analytical Validation and Commercial Manufacturing) across CMC functions and departments, enabling project delivery in line with time, financial and quality requirements. Primary responsibilities for the position include:

  • Collaborate with CMC Leaders to define CMC strategy for our product development programs
  • Lead the translation of strategy into integrated CMC timelines and deliverables across all Development projects and communicate the plan to all key stakeholders. This includes timelines for activities to support Oligonucleotide Development, Process Development, Analytical Development, Process Transfer (to CMOs), Quality Control and Manufacturing (Drug Substance, Drug Product Fill/Finish and packaging).
  • Conduct critical path analyses and pro-actively identify resource constraints/bottlenecks; continually work with the CMC Team to review and address issues.
  • Manage the CMC team deliverables, scope, timelines, resources on project activities so the program remains within budget, on schedule, and within scope. Identify and analyze project risks and help guide CMC team to develop appropriate mitigation strategies.
  • Support the CMC leader by organizing, scheduling, and facilitating CMC team meetings to review CMC Plans, CMC risks, CMC deliverables, and minute actions
  • Provide coordination and logistical support to CMC Team and CMC working groups to coordinate and manage CMO activities (Tech Transfer and GMP Manufacturing support), including scheduling meetings, facilitating and tracking the exchange of information, drafting meeting minutes and coordinating calendars.
  • Provide coordination and logistical support to Joint Manufacturing Committee (“JMC”) and operational sub-committees including scheduling meetings, facilitating and tracking the exchange of information, drafting meeting minutes and coordinating calendars
  • Ensure functional area “buy-in”, Product Development Team (PDT), and management approval for each CMC Plan and all updates.
  • Facilitate communications and interactions involving team members and external partners.
  • Develop and maintain ownership of CMC project documentation including the CMC Integrated Project Plan (IPP).
  • Develop and provide consistent project reporting to the CMC and Project Teams and CMC Project status reporting to Senior Management.
  • Develop, maintain, improve, manage and train new CMC team members on the CMC SharePoint site. CMC PM is the owner of the CMC SharePoint site and will work with external SharePoint consultant to implement site improvements on a semi-annual basis.
  • Consult and communicate with functional areas between development team meetings to ensure project plans and other documentation is updated prior to each development team meeting
  • Provide CMC input to the company’s annual operational plans and budgetary process
  • Leverage and apply operational management experience where appropriate to support alliances and collaborations
  • Work with the Regulatory Department to develop timelines to support CMC submissions (e.g., INDs and BLAs) and provide structure and leadership to ensure all CMC sections of regulatory submissions are of high quality and completed on-time.
  • Initiate and monitor the preparation of regulatory documents by CMC and relevant team members
  • Work closely with miRagen management, committee members, and partner companies to ensure alignment between activities performed under the terms defined in the collaboration and license agreements, and miRagen’s strategic, operational and financial planning
  • Maintain the integrity of company’s data base and physical legal files for all agreements; proactively identify when extensions/renewal are required

QUALIFICATIONS AND REQUIRED SKILLS

  • Suitable candidates will possess a Bachelor’s degree in a relevant technical discipline or Life Sciences and a minimum 5 years of relevant industry experience, including a minimum of 2 years CMC project management.  Advanced degree and/or PMI or PMP certification desired
  • Must have experience in project management techniques and principles including: project planning, execution and tracking, risk identification, resource and financial project planning
  • Comprehensive understanding of the CMC development strategies across IND-BLA stages.
  • Strong technical/analytical skills to identify and solve problems in a fast-paced environment.
  • Working knowledge of cross-functional drug development processes, FDA/ICH/EMA guidelines, and cGMP’s.
  • Experience in preparation and submission of CMC documents in support of regulatory filings.
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company, vendors, and contract sites.
  • Strong organizational skills to maintain a high level of productivity, innovation, and setting priorities in order to complete assignments in a timely manner and within budget. •
  • Exhibits high initiative, strong drive, and follow-through.
  • High level of commitment, flexibility and strong planning, coordination, teamwork, communication and interpersonal skills
  • Must be highly proficient with Microsoft Project, Microsoft Excel, Microsoft PowerPoint, SharePoint, and SmartSheet.
  • Some travel may be required (5-10%)