Manufacturing Specialist - NPI

NPI Manufacturing Specialist in Albuquerque, NM

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We proudly offer

•    Generous benefit options (eligible first day of employment)
•    Paid training, vacation and holidays (vacation accrual begins on first day of employment)
•    Career advancement opportunities
•    Education reimbursement
•    401K program with matching contributions
•    Learning platform
•    And more!

As a member of the NPI Tech Transfer Team, this position is responsible for supporting New Product Introduction (NPI) and technology transfer activities within their assigned functional area (e.g., Quality, Technical Operations, Validation, Microbiology, Analytical Sciences, Manufacturing, etc.). This role serves as the primary Subject Matter Expert (SME) for the functional area throughout the NPI lifecycle, providing technical leadership, risk assessment, planning, execution support, and operational readiness to ensure successful transfer and efficient commercialization of new products.

Working as a core member of the NPI Tech Transfer Team, the SME collaborates closely with Program Management, Operations, Quality, Regulatory, as a member of the customer-facing team working to drive project execution through Tech Transfer stage gates, facilitate knowledge transfer, identify and mitigate risks, and ensure compliance with site procedures, regulatory requirements, and customer expectations. The position is dedicated to NPI activities and serves as the functional customer-facing point of contact for multiple concurrent tech transfer programs.

The Manufacturing Specialist responsible for supporting daily manufacturing operations by ensuring production processes, materials, documentation, and personnel are aligned to achieve operational excellence. Serves as a subject matter expert for manufacturing processes, providing guidance during deviation, investigation, CAPA, and documentation review activities while ensuring compliance with GMP and procedural requirements. Collaborates cross-functionally with Quality, Engineering, Technical Operations, Supply Chain, and Manufacturing leadership to resolve complex production issues, optimize processes, improve safety, and drive continuous improvement initiatives. Supports material procurement, SOP development and revision, training compliance, and manufacturing readiness while identifying and eliminating operational bottlenecks to enhance efficiency, product quality, and production performance.

Essential Duties and Responsibilities:  
•    Act as the designated functional SME for all assigned NPI and technology transfer projects.
•    Participate in cross-functional Tech Transfer teams from project initiation through commercial launch, collaborating with Manufacturing, Quality Assurance, Engineering, Technical Operations, and other functions to support successful execution and implementation of new products and processes.
•     Lead discipline-specific assessments, gap analyses, risk evaluations, and readiness reviews, including identification and resolution of operational bottlenecks, process gaps, and execution barriers.
•    Support development and execution of project plans, timelines, and deliverables required for Tech Transfer stage gates, including activities necessary to support development, validation, and commercial manufacturing.
•    Provide technical expertise during customer meetings, technical discussions, audits, governance reviews, and leadership meetings, and represent the Manufacturing function in cross-functional forums related to assigned areas of responsibility.
•    Partner with Program Managers and cross-functional teams to identify project and operational risks, develop mitigation plans, and establish appropriate escalation pathways.
•    Ensure functional deliverables, documentation, and approvals are completed in accordance with established procedures, project timelines, GMP requirements, and regulatory standards.
•    Drive operational readiness activities necessary to support development, validation, and commercial manufacturing, including maintaining a comprehensive working knowledge of manufacturing processes, production lines, equipment, and operational areas.
•    Support knowledge transfer activities between sending and receiving organizations, ensuring effective and efficient transfer of process, product, analytical, and operational knowledge.
•    Participate in Technical Review Boards (TRBs), stage gate reviews, and leadership governance meetings.
•    Collaborate with cross-functional departments to investigate and resolve complex technical and manufacturing challenges, including equipment malfunctions, process deviations, product quality concerns, and other execution barriers.
•    Contribute to continuous improvement of NPI and Tech Transfer processes, tools, templates, and best practices, including initiatives that improve process flow, workplace safety, product quality, and overall production efficiency.
•    Provide direct support to manufacturing operations through routine floor presence, observation of processes, and partnership with technicians and manufacturing leadership to ensure materials, equipment, procedures, and resources are available to support efficient production execution.
•    Serve as a Manufacturing SME during reviews of deviations, CAPAs, assessments, investigations, and related documentation, providing guidance on manufacturing processes, procedural requirements, and appropriate remediation strategies.
•    Author, revise, and maintain Standard Operating Procedures (SOPs), work instructions, and other manufacturing documentation as needed.
•    Support the timely initiation, investigation, documentation, and closure of deviations, assessments, investigations, and Corrective and Preventive Actions (CAPAs).
•    Collaborate with manufacturing leadership to support the procurement and availability of materials, supplies, equipment, and other resources required for production.
•    Maintain all required training and qualifications in accordance with company and regulatory requirements.
•    Read/interpret SOPs to ensure compliance
•    Maintain up to date trainings
•    Other duties as assigned

Education and Experience:                                                          
Required Qualifications

• High School Diploma or equivalent (GED) 
• Minimum of 3-4 years of experience in a pharmaceutical manufacturing environment, including experience with Aseptic Processing, Formulation, and/or Fill-Finish Operations.
   

Preferred Qualifications

• Bachelor’s degree in Engineering, Business, Science, or a related field, with at least five (5) years of experience in a pharmaceutical manufacturing environment, including experience with Aseptic Processing, Formulation, and/or Fill-Finish Operations.
• Demonstrated leadership experience, preferred.  i.e. Team Lead, Senior Technician, Path Guide, or other informal leadership roles.
• Working knowledge of GMP-regulated manufacturing environments.
• Experience supporting deviation investigations, CAPAs, and process improvement initiatives.
   

Supervisory Responsibilities:                                                            
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Other Skills and Abilities:                                                
•    Ability to cultivate a culture of continuous improvement and right first-time quality
•    Fosters a collaborative and positive work environment
•    Champions change
•    Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
•    Demonstrates strong attention to detail
•    Strong problem-solving, communication, and cross-functional collaboration skills.
•    Ability to work effectively in a fast-paced manufacturing environment while maintaining compliance with quality and safety standards.

Other Qualifications:
Must pass a background check
Must pass a drug screen
May be required to pass Occupational Health Screening
Must be able to obtain and maintain gowning certification
Must be able to obtain and maintain media qualification 
Must be able to wear a respirator 
 

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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