Program Manager II

TriLink BioTechnologiesSan Diego, CA
5hOnsite

About The Position

Maravai LifeSciences is seeking a #MiracleMaker to join our CDMO team as a Program Manager II. As a Program Manager II you will be responsible for end-to-end management and ownership of GMP Services programs execution at TriLink. The Program Manager II is the single point of contact for GMP Services programs, interfacing with Operations, Commercial, Process Development, Quality, Engineering, and other teams to meet customer timelines and deliver milestones. The Program Manager II is expected to be a client’s advocate within the organization and actively problem solve to ensure excellent customer service, and deliver on timelines. This role is expected to fully manage and own customer contractual deliverables and use organizational and collaboration skills to lead cross-functional project teams with internal business and technical partnership to ensure that the contractual obligations are met. The Program Manager II will also apply their technical knowledge and problem-solving abilities to help overcome program challenges and make recommendations to help meet customer expectations.

Requirements

  • Bachelor’s degree in Business, Engineering, Life Sciences, or a related field, with 2-4+ years of relevant experience in customer-facing project/program management and/or customer-facing technical roles. Applicants with a master’s degree or higher may have 0-2 years of direct experience.
  • Direct experience in biotechnology/pharmaceutical industry working in pre-IND to late-phase clinical drug substance and drug product development. Adjacent project experience in CDMO environment may count towards years of experience.
  • Direct experience working within a CDMO managing client’s program portfolio, or relevant experience operating within a CDMO Project Core Team, required.
  • Working knowledge of CMC considerations with respect to quality systems, GMP, ICH guidelines, FDA, USP, and associated regulatory requirements required.
  • Excellent leadership and interpersonal skills required.
  • Project management experience with direct management of projects required, or experience managing a broader project portfolio or participating within project teams, including experience utilizing key programs in an Operations environment such as MS Project, Smartsheet, MS Office, and ERP systems such as NetSuite.
  • Strong interpersonal skills with demonstrated ability to build relationships within a matrixed organizational environment.

Nice To Haves

  • Experience with the manufacture of mRNA and plasmids is a nice to have.

Responsibilities

  • Directs, leads, and motivates multi-disciplinary project teams to deliver customer GMP Services project milestones from pre-Clinical through to Commercial phases, while also supporting customer engagement by being a liaison between the customer and internally facing teams.
  • Actively manages up to 3+ small to medium size and complexity customer drug development and manufacturing programs.
  • Actively manages contractual obligations and milestones and flags to their management when additional scope is identified requiring a new proposal, Change of Scope, or there are billing, audit requests, or other items that arise.
  • Facilitates regular and effective internal & customer-facing team meetings that drive collaboration including structured agendas, integrated schedules, key performance measures, risk/issue management, timely communication of meeting minutes, action items and other.
  • Maintains accurate project timelines and other related Project Management tools, and has intimate knowledge of all programs under management and works with Leadership to proactively identify and escalate potential risks and opportunities to mitigate to ensure that programs are kept on-track.
  • Facilitates regular meetings internally and with clients to monitor and manage progress of project execution to the Statement of Work and work through open items to ensure milestone delivery.
  • Participates in internal operating mechanisms and reports-out to PgM Leadership on the overall progress of programs along with potential risks & opportunities, customer health, and other metrics where appropriate.
  • Perform other functions and duties as required.

Benefits

  • You have the potential to change, improve, and save lives around the world.
  • You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
  • We offer comprehensive medical plans and HSA/FSA options.
  • Fertility & family planning assistance.
  • A variety of additional optional benefits and insurance options, including pet insurance.
  • Retirement contributions.
  • Holidays & Paid Time Off.
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