Manufacturing Specialist

Payrate: $33.00- $35.00/hr.
 
Summary
The Client is seeking a Specialist Manufacturing New Product Introduction (NPI) to support a drug product manufacturing facility. This role is responsible for leading the introduction of new products into manufacturing operations and serving as a key liaison across Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. The successful candidate will manage technology transfer project planning, oversee project execution, ensure compliance with regulatory requirements, and drive cross-functional collaboration to deliver new product introductions on schedule. This position requires strong project management, problem-solving, and communication skills in a regulated manufacturing environment.
 
Responsibilities

• Lead new product introduction projects and technology transfer activities within the manufacturing facility.
• Develop, maintain, and execute NPI project plans, ensuring accountability for project scope, schedules, milestones, and risk management.
• Coordinate and influence cross-functional teams to achieve project objectives and deliverables on time.
• Resolve project issues in a timely manner and escalate concerns to management when appropriate.
• Own and manage Change Control records within the quality system, ensuring completeness, accuracy, and compliance with GMP requirements.
• Lead and facilitate cross-functional meetings to track project progress and address business needs.
• Communicate project status, risks, and key updates through verbal presentations, written reports, and stakeholder communications.
• Collaborate with Quality and Regulatory teams to ensure compliance with applicable requirements and support regulatory submissions.
• Support continuous improvement efforts by identifying opportunities, building consensus, and implementing process enhancements.
• Review manufacturing protocols and partner with Quality Assurance to ensure compliance with current procedures, batch records, and quality standards.
• Conduct manufacturing floor observations and assessments to identify process improvement opportunities related to NPI and product lifecycle management activities.
• Track team and plant metrics and provide visibility into operational performance and deliverables.
• Represent the team in plant-wide and network-wide meetings and forums as needed.
• Document lessons learned and supported continuous improvement initiatives for future project execution.
• Maintain awareness of material status and provide regular updates to management on project progress, risks, and concerns.
• Identify potential issues and proactively escalate challenges to ensure project success.

 
Education Requirements

• Bachelor’s degree in scientific, engineering, manufacturing, or related discipline is preferred.

 
Experience Requirements

• Experience leading or supporting cross-functional projects in a manufacturing or regulated environment.
• Experience working with quality systems, changing control processes, or compliance-related activities.
• Experience in drug product manufacturing or related operations is preferred.
• Project management experience is required.
• Direct or indirect leadership experience is preferred.

 
Required Skills

• Strong project management skills with the ability to influence cross-functional teams and maintain project timelines.
• Excellent organizational skills and attention to detail.
• Independent problem-solving and analytical troubleshooting capabilities.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong technical writing skills and the ability to communicate complex information clearly and concisely.
• Knowledge of manufacturing operations, scientific methods, and regulatory compliance expectations.
• Ability to lead meetings, coordinate stakeholders, and drive decisions.
• Experience using quality systems and documentation processes with a right-first-time approach.
• Ability to work independently while collaborating effectively across multiple functional groups.
• Strong time management and prioritization skills.

 
Preferred Skills

• Understanding of drug product formulation and vial or syringe filling operations.
• Experience with quality systems, including change control, deviations, corrective and preventive actions (CAPA), and validation practices.
• Experience working in regulated environments, including cGMP manufacturing.
• Demonstrated leadership skills through direct or indirect people management responsibilities.
• Ability to adapt to changing priorities and business requirements.
• Strong collaboration skills with a team-oriented approach.
• Experience supporting technology transfer or new product introduction initiatives.

 
Pay Transparency: The typical base pay for this role across the U.S. is: $33.00 - $35.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
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