Manufacturing Specialist (MSAT) PC 1602

Miltenyi Biotec • Gaithersburg, MD

1d • Onsite

About The Position

Your Role: 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). In addition, this position will support MSAT team to manage supplier qualification of raw materials, supplier change notifications related to the manufacture of Lenti-Viral Vector (LVV) and Cell and Gene Therapy processes. Additionally, the specialist will partner closely with internal and external stakeholders establishing partnerships to ensure compliance with cGMP and Quality Management systems to deliver our services to the clients effectively. Essential Duties and Responsibilities: Own, initiate, and manage timely completion of Manufacturing related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Controls. Coordinate the development, writing, collaboration and review of Standard Operating Procedures (SOPs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation. Troubleshoot processing issues, investigating in detail and establishing root cause and resolution/corrective action. Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams. Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments. Prepare periodic reports and present data to internal and external stakeholders as needed. Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team. Additional Responsibilities: Work with operations team to create a culture of accountability, ownership, and continuous improvement. Respect all safety, laboratory policies, and practices on site. Work across departments and/or sites. Work with process engineers and manager to align the priorities of the team with those of the department. Able to work independently; shows initiative and able to work with all levels of staff.

Requirements

• Bachelor’s degree in these same disciplines and a minimum of 3 years of relevant and progressively responsible experience in these same areas (required) or master’s in science/chemical engineering or related field and a minimum of 2 years of progressively responsible experience in biologics/gene therapy manufacturing, MS&T or AS&T roles.
• At least 3 years of related experience in a GMP biologics manufacturing environment.
• Previous GMP experience in handling deviation, change controls, CAPA using appropriate quality system is required.
• Excellent oral and written communication skills.
• Strong technical writing ability required.
• Ability to work cross functionally within the organization as part of a project team.
• Work experience in biologics for late-stage and commercialization of products with a good understanding of GMP operation is required.
• Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory, and Quality teams.
• Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines.
• Experience in using the statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required to evaluate trends.
• Excellent communication skills with good technical writing skills with a proven ability to work with internal and external partners
• Project management skills including planning, execution, risk and change management.
• Good interpersonal and communication skills.
• Effective team player.
• Analytical skills with logical thinking problem solving skills.
• Good knowledge of Microsoft office.

Nice To Haves

• Prior cell therapy experience is highly preferred.
• Involvement in prior manufacturing process tech transfer is preferred.

Responsibilities

• Own, initiate, and manage timely completion of Manufacturing related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Controls.
• Coordinate the development, writing, collaboration and review of Standard Operating Procedures (SOPs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation.
• Troubleshoot processing issues, investigating in detail and establishing root cause and resolution/corrective action.
• Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams.
• Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments.
• Prepare periodic reports and present data to internal and external stakeholders as needed.
• Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team.
• Work with operations team to create a culture of accountability, ownership, and continuous improvement.
• Respect all safety, laboratory policies, and practices on site.
• Work across departments and/or sites.
• Work with process engineers and manager to align the priorities of the team with those of the department.
• Able to work independently; shows initiative and able to work with all levels of staff.

Benefits

• In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan.
• All benefits are subject to eligibility requirements.
• Certain positions may also be eligible for additional compensation such as bonuses or commissions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level