Manufacturing Specialist

Curia • Albuquerque, NM

6d

About The Position

The Manufacturing Specialist supports New Product Introduction (NPI) and technology transfer activities as the designated manufacturing subject matter expert (SME) for assigned projects. As a customer-facing member of the NPI Tech Transfer Team, the role provides technical leadership, risk assessment, planning, execution support, and operational readiness across the transfer lifecycle, from project initiation through commercial launch. The Specialist collaborates with Program Management, Manufacturing, Quality, Regulatory, Engineering, Technical Operations, and other functions to facilitate knowledge transfer, meet project stage gates, and ensure compliance with site procedures, GMP requirements, regulatory standards, and customer expectations. The position supports multiple concurrent technology transfer programs.

The role also supports day-to-day manufacturing operations by helping align production processes, materials, documentation, personnel, equipment, and resources for efficient and compliant execution. The Specialist provides manufacturing expertise in investigations, deviations, CAPAs, assessments, and documentation reviews; authors and maintains SOPs and work instructions; supports training compliance and material procurement; and works with colleagues to resolve production challenges, improve safety and product quality, and remove operational bottlenecks. The role has no formal supervisory responsibilities, but may include mentoring, guiding, and advising others.

Requirements

• High school diploma or equivalent (GED).
• At least nine years of experience in a pharmaceutical manufacturing environment, including experience with Aseptic Processing, Formulation, and/or Fill-Finish Operations.
• Must pass a background check and drug screen.
• May be required to pass Occupational Health Screening.
• Must be able to obtain and maintain gowning certification and media qualification.
• Must be able to wear a respirator.
• Strong attention to detail, problem-solving, communication, and cross-functional collaboration skills.
• Ability to work effectively in a fast-paced manufacturing environment while maintaining quality and safety compliance.
• Ability to support a collaborative, positive, safe, and continuous-improvement-oriented work environment.

Nice To Haves

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

Responsibilities

• Act as the designated functional manufacturing SME for assigned NPI and technology transfer projects.
• Participate in cross-functional Tech Transfer teams from project initiation through commercial launch, supporting implementation of new products and processes.
• Lead discipline-specific assessments, gap analyses, risk evaluations, and readiness reviews, including identifying and resolving process gaps, operational bottlenecks, and execution barriers.
• Support project plans, timelines, and deliverables for Tech Transfer stage gates and activities supporting development, validation, and commercial manufacturing.
• Provide technical expertise in customer meetings, technical discussions, audits, governance reviews, and leadership meetings; represent Manufacturing in relevant cross-functional forums.
• Partner with Program Managers and cross-functional teams to identify risks, develop mitigation plans, and establish escalation pathways.
• Ensure functional deliverables, documentation, and approvals are completed according to procedures, project timelines, GMP requirements, and regulatory standards.
• Drive operational readiness for development, validation, and commercial manufacturing, maintaining working knowledge of manufacturing processes, production lines, equipment, and operational areas.
• Support knowledge transfer between sending and receiving organizations, including transfer of process, product, analytical, and operational knowledge.
• Participate in Technical Review Boards, stage gate reviews, and leadership governance meetings.
• Collaborate across functions to investigate and resolve technical and manufacturing challenges, including equipment malfunctions, process deviations, product quality concerns, and other execution barriers.
• Contribute to improvements in NPI and Tech Transfer processes, tools, templates, and practices, including improvements to process flow, workplace safety, product quality, and production efficiency.
• Provide routine manufacturing floor support by observing processes and working with technicians and manufacturing leadership to ensure materials, equipment, procedures, and resources are available.
• Serve as a Manufacturing SME in deviation, CAPA, assessment, investigation, and related documentation reviews; advise on manufacturing processes, procedural requirements, and remediation strategies.
• Author, revise, and maintain SOPs, work instructions, and other manufacturing documentation as needed.
• Support timely initiation, investigation, documentation, and closure of deviations, assessments, investigations, and CAPAs.
• Collaborate with manufacturing leadership to support procurement and availability of production materials, supplies, equipment, and other resources.
• Maintain required training and qualifications in accordance with company and regulatory requirements; read and interpret SOPs and keep training current.
• Perform other duties as assigned.

Benefits

• Generous benefit options, eligible on the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401K program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED