Description Operational Readiness Project Lead / Project Manager This role provides cross-functional project leadership for Operational Readiness, ensuring key workstreams are integrated, aligned, and positioned for successful execution. The role focuses on ]scope, schedule, risk, governance, coordination, and issue resolution rather than direct people or budget management.
Scope of Work
Lead project scope definition for Operational Readiness workstreams such as Manufacturing, Engineering, Process Development, Supply Chain, and Quality Control, among others.
Develop execution strategies, detailed schedules, and risk registers.
Integrate and actively facilitate workstreams day-to-day execution.
Facilitate teams meetings and execution forums.
Represent workstreams in appropriate governance forums.
Liaise with other project PMs to ensure effective project delivery.
Closely manage schedule performance and provide updates to management.
Ensure internal alignment of operational readiness schedules, as well as externally with construction and commissioning/qualification workstreams.
Provide strategic guidance on overall project delivery to de-risk and optimize execution.
Resolve workstream issues arising throughout the project, manage risk register, and escalate when appropriate to keep objectives and deliverables on track.
Lead and facilitate cross-functional workshops required to ensure project alignment, solve project challenges, identify gaps, and advance site strategy.
Won't manage people, nor budget.
Specific Skills
Knowledge/experience in Biologics Drug Substance manufacturing operations (ideally Downstream and/or Upstream operations).
Knowledge/experience in BioPharma operations and inspection readiness.
Knowledge/experience in BioPharma supporting audits and inspections.
Knowledge/experience supporting operations functions such as Quality Control, Process Development, Engineering, Supply Chain, etc.
Knowledge/experience with Commissioning and Qualification.
Understanding of manufacturing support systems (ie MES, PI, DeltaV, etc).
Understanding of operations support systems (ie Trackwise, LIMS, Maximo, etc).
Basic Qualifications Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience
Top 3 Must Have Skill Sets: Stakeholder & Cross-Functional Leadership, Risk, Dependency & Integrated Planning Management, and Technical & Business Acumen
Day to Day Responsibilities: Support integrated teams through planning, mitigations, with facilitation and management of deliverables based on timeline needs.
Possible Extension: Yes
Red Flags: No Clearly Defined Business Outcome, Stakeholders Are Not Aligned, no identified ownership and an inability to manage risk and timelines
Interview Process: Intent is to have a digital interview with 1-2 managers and a second interview with involved stakeholders (1-2 customers)
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $62.00/hr - $74.00/hr.
