Director, MSAT *PC 541

Your Tasks:

This position is responsible for overseeing the Manufacturing Sciences and Technology activities for the scalable production of cellular therapeutics and lentiviral vector capable of supporting product lifecycle management from Phase I clinical trials through commercialization. The Director of MSAT will be responsible for leading the transfer and refinement of processes and methods from clients or process development to GMP Operations ((Manufacturing (MFG) or Quality Control (QC)) or from Miltenyi BioIndustry to an external receiving site. The Director of MSAT will be responsible for developing process control strategies and process improvement as well as Process Characterization and validation in support of commercialization.

Essential Duties and Responsibilities:

• Lead the strategic development and implementation of MSAT team structures, procedures, and initiatives to facilitate process and analytical product lifecycle management groups towards the timely delivery of defined goals and objectives on behalf of Client and internal projects.
• Drive technology transfer strategic planning, development and execution of timelines to meet project goals, working with project teams.
• Work collaboratively with appropriate internal business units to guide CDMO project lifecycle from new client onboarding through transfer to Operations (cell factory and lentiviral vector), as well as outgoing technology transfer.
• Develop and review SOP's for analytical methods, master production records (MPR, BPR, SMP) and other applicable GMP documents to ensure they meet process requirements and control systems.
• Support ongoing GMP production through establishing systems for process trending, risk assessment, troubleshooting, investigating process deviations, and implementing corrective and preventative actions.
• Oversee the transfer and improvement of manufacturing processes and assay methods from Phase I to commercialization.
• Oversee product lifecycles activities including development of CPPs, control strategies, product characterization, continuous improvement, process validation, and decommissioning.
• Maintain accurate records of experimental results, analysis and interpretation of experimental data.
• Develop the technology transfer portion of project proposals for potential clients, including timelines, material and labor costs.
• Prepare and present technical reports and data to appropriate groups.
• Manage department budget and spending.
• Summarize cell processing and lentiviral data for potential publication and/or presentation to internal and external audiences.
• Provide technical leadership and impact assessment during deviation investigation and Corrective and Preventive Action (CAPA) activities, risk assessments, root cause analysis and similar activities related to clinical manufacturing of cellular therapy products.
• Support Compliance activities (internal, client audits and Agency inspections).
• Maintain Process Verification reports/data analysis as required.

Requirements:

• Bachelor's Degree in Life Science or related discipline, master's degree in Life Science or related discipline preferred, Ph.D. in Life Science or related discipline preferred; 8-12 years relevant experience in MSAT, TechOps, Process Development, Analytical Development, and Manufacturing Operations. A minimum of 7 years' experience in a progressive manager role; or equivalent combination of education and experience.
• Knowledgeable regarding the drug development process including data required to support IND, PPQ, and BLA submissions.
• Working knowledge of regulatory requirements for release and FIO (for information only) assays.
• Previous experience with working with human blood and tissue; Cell Factory processing and/or Lentiviral processing.
• Sound understanding of cGMP, GLP and related regulatory guidance.
• Fluent knowledge of relevant molecular biology assays (e.g., VCN).
• Familiarity with analytical technology landscape as pertains to cell therapy and lentiviral characterization.

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 stand, walk, sit, life and/or move. While performing the duties of this job, the employee is regularly required to use eye/hand/foot coordination.

Working 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 an office environment.

The anticipated base salary range has been established at $202,400 -$273,800/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.

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.