Project Manager

RXinsider LTD.; Bedford (OH); On-site; USD 59,000 - 120,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio is seeking a dedicated Project Manager to lead cross-functional initiatives within the site.

You will develop and manage integrated project plans for technology transfer and CQV activities, coordinating with Manufacturing, Engineering, Quality, Validation, Supply Chain, Regulatory, R&D, EHS, and external partners. Responsibilities include delivering projects on time, within scope and budget, maintaining documentation, and applying GMP and company

Qualifications

• B.S. degree in engineering, science, or equivalent related work experience.
• 2+ years of experience in project management and/or GMP or other regulated manufacturing environments, with pharmaceutical experience preferred.
• Knowledge of cGMPs, FDA guidelines, and pharmaceutical or other industry practices.
• Experience using project management tools to develop and maintain schedules, with Microsoft Project preferred.
• Experience of project management principles, including planning, stakeholder management, risk management, and project governance.
• Experience of technology transfer/NPI processes and/or construction, commissioning, and qualification (CQV) projects.
• Excellent written and verbal communication skills.
• Solid organizational skills including attention to detail and multitasking skills.

Responsibilities

• Manage work packages within larger initiatives and lead small- to medium-scale projects through the full project lifecycle, ensuring delivery on time, within scope, budget, and quality expectations.
• Develop, maintain, and execute integrated project plans and schedules using Microsoft Project, including milestones, dependencies, critical path, resource requirements, and progress tracking.
• Partner with site leadership and cross-functional teams to define project scope, objectives, deliverables, technical requirements, resource needs, and execution strategies.
• Coordinate and influence cross-functional stakeholders, including Manufacturing, Engineering, Quality, Validation/Technical Services, Supply Chain, Regulatory, R&D, EHS, and external vendors or contractors to achieve project objectives.
• Ensure project plans and execution activities align with GMP requirements, quality systems, EHS expectations, site procedures, and applicable compliance standards.
• Identify, assess, and manage project risks, issues, assumptions, scope changes, costs, and key decisions, driving timely resolution and escalating to management as appropriate.
• Lead project meetings, workshops, and routine status reviews; communicate schedules, progress, risks, decisions, and resource needs to leadership and relevant stakeholders.
• Maintain comprehensive project documentation and utilize appropriate project management tools, spreadsheets, process maps, performance metrics, and reporting methods to monitor execution and successful completion of short- and long-term goals.

Skills

Communication skills

Organizational skills

Attention to detail

Multitasking

GMP knowledge

Education

B.S. degree in engineering, science, or equivalent related work experience

Tools

Microsoft Project

Job description

Job Title: Project Manager

Location: Bedford, Ohio

Job Type: Full-time (onsite)

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Project Manager to join our team. In this role, you will be responsible for developing and managing plans across a range of projects throughout their lifecycle. Their primary focus will be developing and executing plans for technology transfer / new product introduction for aseptic manufacturing processes to the Bedford site, including construction, commissioning, and qualification (CQV) projects for new and existing equipment and facilities.

You will work with team members across all levels of the organization, with close collaboration with domestic and international teams.

Key Responsibilities:

• Manage work packages within larger initiatives and lead small- to medium-scale projects through the full project lifecycle, ensuring delivery on time, within scope, budget, and quality expectations.
• Develop, maintain, and execute integrated project plans and schedules using Microsoft Project, including milestones, dependencies, critical path, resource requirements, and progress tracking.
• Partner with site leadership and cross-functional teams to define project scope, objectives, deliverables, technical requirements, resource needs, and execution strategies.
• Coordinate and influence cross-functional stakeholders, including Manufacturing, Engineering, Quality, Validation/Technical Services, Supply Chain, Regulatory, R&D, EHS, and external vendors or contractors to achieve project objectives.
• Ensure project plans and execution activities align with GMP requirements, quality systems, EHS expectations, site procedures, and applicable compliance standards.
• Identify, assess, and manage project risks, issues, assumptions, scope changes, costs, and key decisions, driving timely resolution and escalating to management as appropriate.
• Lead project meetings, workshops, and routine status reviews; communicate schedules, progress, risks, decisions, and resource needs to leadership and relevant stakeholders.
• Maintain comprehensive project documentation and utilize appropriate project management tools, spreadsheets, process maps, performance metrics, and reporting methods to monitor execution and successful completion of short- and long-term goals.

Qualifications:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• B.S. degree in engineering, science, or equivalent related work experience is required.
• 2+ years of experience in project management and/or GMP or other regulated manufacturing environments, with pharmaceutical experience preferred.
• Knowledge of cGMPs, FDA guidelines, and pharmaceutical or other industry practices.
• Experience using project management tools to develop and maintain schedules, with Microsoft Project preferred.
• Experience of project management principles, including planning, stakeholder management, risk management, and project governance.
• Experience of technology transfer/NPI processes and/or construction, commissioning, and qualification (CQV) projects.
• Excellent written and verbal communication skills.
• Solid organizational skills including attention to detail and multitasking skills.

Compensation:

Base Salary: $59,900 to $120,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.