Project Manager Senior

Actalent; Holly Springs (NC); On-site; USD 96,000 - 117,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Paid time off

Job summary

Actalent seeks a Project Manager for Operational Readiness at a biologics site in Holly Springs, NC. This contract role focuses on scope, schedule, risk, governance, and cross-functional coordination across Manufacturing, Engineering, Process Development, Supply Chain, and Quality Control.

You will de‑risk and optimize project delivery with strategic guidance, driving on‑time start‑up and compliant operations without direct people or budget management responsibility.

Qualifications

• Experience in biologics drug substance manufacturing operations.
• GMP compliance and inspection readiness experience.
• Experience supporting audits in biopharma or biologics.
• Ability to coordinate across Quality, Process Development, Engineering, and Supply Chain.
• Knowledge of C&Q activities for facilities and systems.
• Proven track record leading complex cross-functional workstreams.
• Ability to manage schedules, dependencies, and risks across teams.
• Experience leading cross-functional workshops and governance meetings.

Responsibilities

• Define project scope for Operational Readiness workstreams across functions.
• Develop execution strategies, schedules, and risk registers.
• Coordinate day-to-day execution across multiple workstreams.
• Lead meetings, forums, and cross-functional sessions to track progress.
• Provide updates, risk assessments, and recommendations to governance.
• Collaborate with project managers for integrated delivery across construction, commissioning, qualification, and operations.
• Monitor schedule performance and critical path, provide status to management.
• Align internal readiness schedules with construction and qualification workstreams.
• Offer strategic guidance to de-risk and optimize sequencing.
• Identify and mitigate risks; maintain risk register and escalate as needed.
• Facilitate cross-functional workshops to drive alignment and address gaps.
• Support inspection readiness and audit prep with Quality and Manufacturing.
• Coordinate with tech and operations to ensure systems readiness.

Skills

Biologics ops

GMP & inspection readiness

Cross-functional coordination

Project governance

Schedule management

Risk management

MES/PI/DeltaV knowledge

TrackWise/LIMS experience

Stakeholder management

Facilitation & workshops

Education

Doctorate + 3y or Master +5y or Bachelor +7y or Associate +12y or HS Diploma +14y

Tools

MES

PI

DeltaV

LIMS

TrackWise

Job description

Job Title: Project Manager - Operational Readiness Job Description 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.

Essential 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.
• 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.

Additional Skills & Qualifications

• 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.

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.

Job Type & Location

This is a Contract position based out of Holly Springs, NC.

Pay and Benefits

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. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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)

Workplace Type

This is a fully onsite position in Holly Springs, NC.

Application Deadline

This position is anticipated to close on Oct 2, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.