Manufacturing Specialist *PC 1455

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). 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.
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  Work with operations team to create a culture of accountability, ownership, and continuous improvement.

  
  
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  Respect all safety, laboratory policies, and practices on site.

  
  
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  Work across departments and/or sites.

  
  
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  Work with process engineers and manager to align the priorities of the team with those of the department.

  
  
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  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, 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; OR the equivalent combination of education and experience.
• 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.
• Prior cell therapy experience is highly preferred.
• Involvement in prior manufacturing process tech transfer is preferred.
• 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.
• Analytical skills with logical thinking problem solving skills.
• Good knowledge of Microsoft office.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to cultured human cells (immortalized, not primary) and lentivirus-derived vector particles. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, glasses and gloves. The noise level in the work environment is usually moderate.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.