Scientist I, Analytical Science & Technology *PC 1429

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.

Summary:

The Analytical Science and Technology (AS&T) Scientist will be responsible for late-stage analytical method transfer and validations from external partners into Quality Control (QC) operations. The role will manage the method transfer, technical support and life cycle, including method qualification, validation, transfer, and data trending.

Additionally, the scientist 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.

Responsibilities:

• Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams.
• Lead the transfer and implementation of QC methods which may include review of assay development, optimization, assay transfer and assay qualification plans for Quality Control functions (i.e. testing of raw materials, intermediates, finished products, and stability testing).
• Acts as a subject matter expert (SME) and leads laboratory investigations for deviations and Out of Specification results. Coordinating nonconformity, deviation and root cause analysis as per Quality Control and Quality Assurance procedures.
• Be a key contributor to analytical method continuous improvement and lifecycle management.
• Author technical documents, such as method SOP, development report, qualification protocols, report, and risk assessments.
• Conducts data analysis and trending for Quality Management relevant data. May monitor KPI's as related to development testing and assay transfer.
• Support regulatory inspections as a SME and interface with regulatory agencies related to technical transfer, assay development and optimization.
• Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments. Prepare monthly reports and present data to internal and external stakeholders as needed.
• Knowledge management by preparing templates, procedures and effective training to ensure methods/ knowledge are effectively transferred to routine testing team.

Additional Responsibilities:

• Works with QC team to create a culture of accountability, ownership, and continuous improvement
• Respects all safety, laboratory policies, and practices on site
• Works across departments and/or sites
• Works with senior specialists/ chemists 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
• Provides adequate guidance and technical support to other team(s) when necessary

Requirements:

• Required: Master's degree in molecular biology, virology, biochemistry or related field and 9 years of relevant and progressively responsible experience in biologics/gene therapy Quality Control, MS&T or AS&T roles OR the equivalent combination of education and experience
• Preferred: PhD in molecular biology, virology, biochemistry or related field and a minimum of 7 years of progressively responsible experience in biologics/gene therapy Quality Control, MS&T or AS&T roles.
• Demonstrated expertise in analytical method qualification, validation, and transfer for biologics products.
• Working experience in biologics analytical and CMC development activities required for late-stage and commercialization of products with a good understanding of GMP operation is required.
• Experience in external orientation: proactive communication, collaboration and exchange between sending and receiving Units.
• Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory, and Quality teams.
• In-depth, hands-on experience in cell-based bioassays preferred including Flow Cytometry, qPCR, HPLC, ELISA, and molecular biology techniques.
• Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines related to analytical assays.
• Experience in using the statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required to evaluate method validation criteria and perform DOE based robustness studies.

Skills:

• Excellent communication skills with good technical writing skills with a proven ability to work with internal and external partners
• Planning and Organizing skills
• Good interpersonal and communication skills
• Effective team player
• 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. 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 15lbs. 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. Must be able to travel routinely by car and plane.

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, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.

As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide. Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights.

These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow. Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all. Every day presents a chance to make a tangible impact and play a key role in accelerating the journey of research from the lab to the market.

Join Miltenyi Biotec and immerse yourself in an environment where your efforts are significant, your contributions are valued, and your work truly matters.

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