Manufacturing Specialist *PC 1379

Miltenyi Biotec Inc; Gaithersburg (MD); On-site; USD 88,000 - 120,000; Full time

Job summary

An established industry player is seeking a dedicated specialist for its Manufacturing Science and Technology team. This role involves managing GMP documentation and quality events while ensuring compliance with regulatory standards. You will collaborate with various stakeholders to drive project success and promote a culture of continuous improvement. If you have a strong background in biologics manufacturing and enjoy working in a dynamic environment, this opportunity is perfect for you. Join a passionate team committed to advancing cell and gene therapy solutions.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Qualifications

• 3+ years of experience in biologics/gene therapy manufacturing.
• Excellent communication and technical writing skills.

Responsibilities

• Manage Manufacturing related Quality Events (deviations, CAPAs).
• Develop and review GMP documentation including SOPs and BPRs.

Skills

GMP Documentation

Quality Events Management

Technical Writing

Cross-Functional Collaboration

Statistical Tools (e.g., JMP)

Analytical Skills

Cell Therapy Experience

Education

Bachelor's Degree in Relevant Fields

Master's Degree in Relevant Fields

Tools

Microsoft Office

Job description

Description

Your Tasks:

This position will be in the Manufacturing Science and Technology team (MS&T) responsible for implementation of GMP documentation (batch records and SOPs) and managing manufacturing related quality events (change controls, deviations, CAPAs). Additionally, this role supports MSAT team activities related to supplier qualification of raw materials, supplier change notifications for the manufacture of Lenti-Viral Vector (LVV), and Cell and Gene Therapy processes.

The specialist will collaborate closely with internal and external stakeholders to ensure compliance with cGMP and Quality Management systems, delivering effective services to clients.

Essential Duties and Responsibilities:

1. Manage timely completion of Manufacturing related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Controls.
2. Develop, write, review, and collaborate on GMP documentation including SOPs, SMPs, BPRs.
3. Investigate processing issues to establish root causes and corrective actions.
4. Work in a cross-functional environment with internal and external teams including Regulatory and Quality.
5. Ensure project success and on-time delivery; prepare reports and present data to stakeholders.
6. Manage knowledge transfer through templates, procedures, and training.
7. Promote a culture of accountability, ownership, and continuous improvement within operations.
8. Adhere to safety and laboratory policies.
9. Collaborate across departments and sites.
10. Align team priorities with department goals with process engineers and managers.
11. Work independently, showing initiative and engaging at all staff levels.

Requirements:

• Bachelor's degree in relevant fields with 3+ years of experience or master's with 2+ years in biologics/gene therapy manufacturing, MS&T, or related areas; or equivalent experience.
• At least 3 years GMP biologics manufacturing experience.
• Experience handling deviations, change controls, CAPAs in GMP settings.
• Excellent communication and technical writing skills.
• Ability to work cross-functionally and in project teams.
• Prior cell therapy experience and manufacturing process tech transfer are preferred.
• Knowledge of GMP operations, regulatory requirements, USP, ICH guidelines.
• Proficiency with statistical tools (e.g., JMP) and analytical skills.
• Good knowledge of Microsoft Office.

Physical Demands:

Regular walking, handling, reaching, talking, hearing; occasional lifting up to 50 pounds; vision requirements; multitasking at a rapid pace.

Work Environment:

Temperature-controlled, sanitized lab; exposure to cultured human cells and lentivirus vectors; standard PPE required; moderate noise level.

The salary range is $88,100 - $119,200/year, with comprehensive benefits including health, dental, vision, and 401(k). Specific benefits depend on eligibility.

Miltenyi Biotec is an EO employer and participates in E-Verify. We are passionate about biomedical research and providing solutions in cell and gene therapy manufacturing.

Equal Opportunity Employer. For applicant rights, see the Know Your Rights notice from the Department of Labor.