To meet our strategy of rapidly advancing our novel products into clinical trials and beyond, we seek the services of a Project Manager to support Attralus’s CMC function. Reporting to Senior Director of CMC Project Management, the Manager will be responsible for managing CMC projects and ensuring timely transfer of data and documents for their various uses, including but not limited to budget reconciliation, regulatory filings, materials distribution and implementation. This role will work both independently and with cross-functional teams to provide high-quality support of multiple projects. The position will function remotely, with limited travel.


ROLES, RESPONSIBILITIES & EXPECTATIONS 

  • Partners with project, functional and work stream leads to successfully achieve project objectives inclusive of program assets as well as strategic initiatives
  • Provides strong team leadership and drive to ensure projects are executed on-time and within budget 
  • Facilitates and drives projects, goals, and deliverables
  • Supports the budgeting process, through work order approval, tracking spends and reconciliation
  • Works on cross-functional teams to ensure approval and efficient transfer of CMC data and documents (GMP and non-GMP) between Attralus and its contract service providers
  • Establishes effective relationships with contract facilities and suppliers to ensure timely transfer and delivery of CMC/GMP data and documentation to support internal projects, regulatory filings, and other external facing activities 
  • Provides project management support to design and implement an efficient process for the approval, management and use of data and documents in support of the development of novel therapeutics, ensuring that project deliverables meet aggressive timelines 
  • Serves as a point of contact with contract service providers regarding the transfer of data associated with CMC development (process, analytical, and formulation), pilot and cGMP manufacturing and testing 
  • Facilitates CMC team meetings, providing clear agendas, definitive action items, and documentation of decisions 
  • Maintains clear and timely communication with cross-functional project team members and key stakeholders to maintain awareness of project status, issues, contingencies, and milestones 
  • Facilitates problem-solving and decision-making independently and as a member of cross-functional teams 
  • Supports the development of CMC project plans and timelines for development programs from candidate selection through IND and beyond, working independently and with stakeholders across functional areas 
  • Supports the authorship of regulatory filings and external communications through tracking completion of Module 3 regulatory sections and authoring 
  • May own CMC GMP SOPs and records (deviations, CAPA and change controls) to support CMC product development


REQUIREMENTS/QUALIFICATIONS 

  • Bachelor's degree or higher, with a minimum of 5 years of experience in the biotechnology or pharmaceutical industry 
  • Experience in managing or coordinating projects is essential 
  • Experience in management of scientific data, including the establishment and/or maintenance of data management systems, is essential 
  • Excellent written and verbal communications skills, both internal and external, are essential 
  • Excellence in teamwork, including both remote and face-to-face interactions, is also essential 
  • Experience with MS Project, Smartsheet, advanced Excel operations is required 
  • Experience in managing external suppliers is highly desirable 
  • Experience with budget reconciliation is highly desirable 
  • Experience in pharmaceutical drug substance and/or drug product CMC development and cGMP manufacturing/testing is highly desirable 
  • Experience in the establishment and/or maintenance of technical documentation systems is desirable 
  • Experience owning and authoring GMP documentation is desirable 
  • Previous support of the authorship of CMC sections of regulatory filings associated with medical products is desirable, with experience in direct authorship preferred 
  • Experience in collaborating with contract service providers is preferred 
  • Familiarity with cGMP, FDA and EMA guidance, ICH guidelines, and CMC content of regulatory submissions is desirable 
  • PMP certification is advantageous
This position has been filled.