Job Title: Operational Readiness Project Lead/Project Manager
Location: Holly Springs, NC 27540
Duration: 15 Months (Possibility of extension depending upon business requirements and performance)
 
Top 3 Must Have Skill Sets:             

• 1 - Operational Readiness & Biopharma Manufacturing Expertise

Strong experience in biologics manufacturing operations, GMP/inspection readiness, and C&Q, with the ability to translate operational requirements into actionable readiness plans.

• 2- Cross-Functional Project & Schedule Leadership

Proven ability to lead complex, integrated workstreams, manage schedules, dependencies and risks, facilitate execution forums, and drive delivery without direct authority over teams.

• 3 - Technology & Manufacturing Systems Knowledge

Working knowledge of critical manufacturing and operations systems, including MES, DeltaV, PI, LIMS, TrackWise, and Maximo, and the ability to connect technology readiness with business and manufacturing operations.
 
Job Description:

• 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

 
Day to Day Responsibilities:          

• Lead the day-to-day execution of Operational Readiness activities across multiple cross-functional workstreams, ensuring priorities, milestones, and dependencies remain aligned.
• Manage integrated schedules, risks, issues, and action plans while facilitating execution meetings and resolving or escalating roadblocks.
• Partner with functional leads, project teams, Construction, and C&Q to maintain alignment and provide clear progress updates to leadership and governance forums.

 
Possible Extension: Yes
 
Red Flags:      

• Limited Biopharma/GMP manufacturing or Operational Readiness experience, particularly in biologics Drug Substance operations.
• Weak experience managing complex cross-functional schedules, dependencies, risks, and execution without direct authority.
• Limited understanding of Commissiong and Qualification and manufacturing/operations systems such as MES, DeltaV, PI, LIMS, TrackWise, or Maximo.
• Primarily administrative PM experience with limited evidence of driving decisions, resolving roadblocks, and influencing stakeholders.
• Limited experience supporting inspection readiness, audits, or regulated/GMP environments.

 
 
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 $65.00/hr - $74.32/hr.