Process Development Associate (Upstream) *PC 977

Your Tasks:

As a member of the Miltenyi Biotec team, you will support the development, characterization, and tech transfer of processes to manufacture purified Lentiviral vectors used for pre-clinical and clinical gene therapy products. Additionally, you will apply your cell culture experience to support production, and characterization, of Lentiviral vectors using adherent and suspension-based production platforms. As a result of your attention to detail and keen ability to reliably produce Lentiviral vectors in a cross-functional team, you will support the continued success of Miltenyi Biotec as a whole.

Essential Duties and Responsibilities:

• Carry out all aspects of upstream vector production with the goal in mind that every effort is aimed at developing and qualifying processes required for clinical gene therapy products.
• Order necessary supplies, maintain laboratory equipment and space, and prepare media and buffers.
• Train team members as needed.
• Track communication of data and ensure efficient progress towards achieving team objectives.

Requirements:

• B.S. Degree in the life sciences or engineering with minimum 2 years of relevant experience; or equivalent combination of education and experience.
• Previous biotech industry experience is preferred, specifically in the fields of gene therapy and virology.
• Adherent and/or suspension mammalian cell culture, transfection and harvest of viral vectors and/or antibodies using aseptic techniques.
• Strong experience utilizing stirred-tank bioreactors in the production of viral vectors and/or antibodies. Disposable and single use stirred-tank bioreactor experience preferred.
• An understanding of DO/pH control loops, PID settings, and scale up and scale down parameters.
• Practical knowledge in a range of bioprocess analytical techniques, such as but not limited to, cell-based assays, flow cytometry, qPCR, Western Blot analysis, and ELISA.
• Superb documentation and organizational skills, capable of providing summaries and generating reports to support technical transfer to Manufacturing as well as process qualification.
• Ability to work in a team and collaborative environment.
• Highly proficient in the use of Microsoft Office products.
• Weekend and holiday work may be required to maintain cell culture vessels or set up assays.
• Experience with late-stage product development, application of QbD principles, as well as statistical design of experiments with JMP software is a plus.

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 biosafety cabinets, CO2 incubators, centrifuges, pumps, bioreactors, microscopes, 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 such as masks, glasses and gloves. The noise level in the work environment is usually moderate.

The anticipated base salary range has been established at $34.71 - $46.97/hr. 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 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.