Project Manager Senior
About the role
with a paragraph. - Responsibilities: many bullet points. Use- .
- Requirements/Qualifications: There's "Essential Skills" and "Additional Skills & Qualifications" and also education/experience requirement: Doctorate degree and 3 years... etc. That's qualifications. We could combine into a Qualifications section. The instruction says use headings like Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which to use. We have both essential skills and additional skills. Could put Skills section for skills list. Qualifications for education/experience. Requirements maybe not needed if we have Qualifications. But we can include both if content.
We have Pay: explicit pay range $70.00 - $85.00/hr. So include Pay section.
Benefits: list of benefits. Include Benefits section.
Schedule: The posting mentions "Work typically involves standard business hours with flexibility required to support critical project milestones, governance forums, and cross-functional workshops." That's schedule info. So we can include Schedule section.
We also have Work Environment etc. Could be part of About the role or separate but not required.
We must not include boilerplate like EEO, etc.
We must not repeat job title as heading.
We must not include Job ID etc.
We must preserve all substantive information.
We need to output only HTML fragment, no /, no markdown fences.
Let's craft.
Structure:
About the role
This role leads cross-functional operational readiness for a biologics manufacturing site, ensuring that all key workstreams are aligned, integrated, and prepared for successful execution. The Project Manager focuses on scope, schedule, risk, governance, coordination, and issue resolution across functions such as Manufacturing, Engineering, Process Development, Supply Chain, and Quality Control. This position influences and drives delivery across teams without direct people or budget management responsibility, providing strategic guidance to de-risk and optimize overall project execution.
Responsibilities
- Lead the definition of project scope for Operational Readiness workstreams, including Manufacturing, Engineering, Process Development, Supply Chain, Quality Control, and related functions.
- Develop detailed execution strategies, integrated project schedules, and comprehensive risk registers for operational readiness activities.
- Integrate and actively facilitate the day-to-day execution of multiple workstreams, ensuring alignment on priorities, milestones, and interdependencies.
- Plan, lead, and facilitate team meetings, execution forums, and cross-functional sessions to track progress, resolve issues, and maintain momentum.
- Represent operational readiness workstreams in appropriate governance forums, providing clear updates, risk assessments, and recommendations.
- Liaise closely with other project managers to ensure effective, integrated project delivery across construction, commissioning, qualification, and operations.
- Closely manage schedule performance, monitor critical path activities, and provide timely status updates and insights to management.
- Ensure internal alignment of operational readiness schedules and external alignment with construction, commissioning, and qualification workstreams.
- Provide strategic guidance on overall project delivery to de-risk execution, optimize sequencing, and support on-time, compliant start-up of operations.
- Proactively identify, manage, and mitigate risks, maintaining the risk register and escalating issues when appropriate to keep objectives and deliverables on track.
- Lead and facilitate cross-functional workshops to ensure project alignment, address project challenges, identify gaps, and advance site strategy.
- Support inspection readiness and audit preparation activities by coordinating with Quality, Manufacturing, and other operational functions.
- Collaborate with technology and operations teams to ensure manufacturing and operations systems are ready, integrated, and aligned with operational needs.
- Operate as a project leader without direct people or budget management, influencing and coordinating across diverse stakeholder groups to achieve project goals.
Qualifications
Doctorate degree and 3 years of experience, OR Master’s degree and 5 years of experience, OR Bachelor’s degree and 7 years of experience, OR Associate’s degree and 12 years of experience, OR high school diploma / GED and 14 years of experience.
Skills
- Strong experience in biologics drug substance manufacturing operations, ideally including upstream and/or downstream operations.
- Demonstrated knowledge and experience in biopharma operations, including GMP and inspection readiness.
- Experience supporting audits and regulatory inspections in a biopharma or biologics manufacturing environment.
- Proven ability to support and coordinate across operational functions such as Quality Control, Process Development, Engineering, and Supply Chain.
- Knowledge and experience with Commissioning and Qualification (C&Q) activities for manufacturing facilities and systems.
- Proven track record leading complex, integrated project workstreams with responsibility for scope, schedule, risk, and governance.
- Demonstrated ability to manage schedules, dependencies, and risks across multiple cross-functional teams.
- Experience facilitating execution forums, governance meetings, and cross-functional workshops.
- Ability to drive delivery and influence outcomes without direct authority over teams or budget.
- Working knowledge of manufacturing support systems such as MES, PI, and DeltaV.
- Working knowledge of operations support systems such as TrackWise and LIMS.
- Strong communication, stakeholder management, and facilitation skills, with the ability to synthesize complex information for diverse audiences.
- Ability to translate operational and GMP requirements into clear, actionable operational readiness plans.
- Experience working in highly regulated biopharma or biologics environments with strong focus on quality and compliance.
- Skill in aligning technology readiness with business and manufacturing operations needs.
- Comfort working in a matrixed organization, coordinating across multiple functions and levels.
- Strong analytical and problem-solving skills to identify gaps, assess risks, and develop mitigation strategies.
- Proficiency in using project management tools and methodologies to plan, track, and report on project progress.
- Experience leading cross-functional workshops to drive alignment, resolve issues, and support strategic decision-making.
Pay
The pay range for this position is $70.00 - $85.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Benefits
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Schedule
Work typically involves standard business hours with flexibility required to support critical project milestones, governance forums, and cross-functional workshops.
We also might include Work Environment? Not required. Check we didn't include any boilerplate. We omitted Job Type & Location, Work Environment, etc. The job type and location could be considered substantive but not under allowed headings. Could we add a short paragraph under About the role? The location is Holly Springs, NC and contract. Could we include that in About the role? It's not prohibited to include location in About the role paragraph. The instruction: "Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a shortor drop it." So we could add location and job type as a short paragraph maybe under About the role or separate small paragraph. But we must not create new headings for them. Could add a
after About the role: "This is a Contract position based out of Holly Springs, NC." That's minor metadata, okay. Also we have Work Environment details; could fold into About the role or separate paragraph but not heading. Might be okay to add a paragraph about work environment. But we must preserve all substantive information. The posting includes "Work Environment The role operates in a highly regulated biopharma and biologics manufacturing environment, working closely with Manufacturing, Engineering, Process Development, Supply Chain, Quality Control, and Quality functions. The Project Manager collaborates extensively with teams involved in construction, commissioning, and qualification, as well as with users of key manufacturing and operations systems such as MES, DeltaV, PI, LIMS, and TrackWise. Work typically involves standard business hours with flexibility required to support critical project milestones, governance forums, and cross-functional workshops. The environment is fast-paced and project-driven, with a strong emphasis on GMP compliance, inspection readiness, and cross-functional collaboration. Work is primarily office-based within a manufacturing or operational site setting, with frequent meetings, structured forums, and workshops to coordinate complex, integrated project activities." We already used schedule sentence; we could incorporate rest into About the role or a separate paragraph (no heading). Let's add a paragraph after About the role: maybe "Work Environment:" but that's heading-like; better to just include as a paragraph. We'll add a paragraph after About the role: "The role operates in a highly regulated biopharma and biologics manufacturing environment, working closely with Manufacturing, Engineering, Process Development, Supply Chain, Quality Control, and Quality functions. The Project Manager collaborates extensively with teams involved in construction, commissioning, and qualification, as well as with users of key manufacturing and operations systems such as MES, DeltaV, PI, LIMS, and TrackWise. The environment is fast-paced and project-driven, with a strong emphasis on GMP compliance, inspection readiness, and cross-functional collaboration. Work is primarily office-based within a manufacturing or operational site setting, with frequent meetings, structured forums, and workshops to coordinate complex, integrated project activities." We already used schedule sentence; we could keep schedule section just about standard business hours flexibility. But we already mentioned schedule in work environment; maybe we should keep schedule section as is and not duplicate. The schedule section we have is about standard business hours with flexibility. That's fine. The work environment paragraph can omit that sentence to avoid duplication. Let's adjust: In work environment paragraph, we can omit the schedule sentence. We'll keep schedule section separate. Thus final HTML:
About the role
This role leads cross-functional operational readiness for a biologics manufacturing site, ensuring that all key workstreams are aligned, integrated, and prepared for successful execution. The Project Manager focuses on scope, schedule, risk, governance, coordination, and issue resolution across functions such as Manufacturing, Engineering, Process Development, Supply Chain, and Quality Control. This position influences and drives delivery across teams without direct people or budget management responsibility, providing strategic guidance to de-risk and optimize overall project execution.
This is a Contract position based out of Holly Springs, NC.
The role operates in a highly regulated biopharma and biologics manufacturing environment, working closely with Manufacturing, Engineering, Process Development, Supply Chain, Quality Control, and Quality functions. The Project Manager collaborates extensively with teams involved in construction, commissioning, and qualification, as well as with users of key manufacturing and