Process Development Associate II (Upstream) *PC 986
About the role
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. Your attention to detail and ability to reliably produce Lentiviral vectors in a cross-functional team will support the continued success of Miltenyi Biotec.
Responsibilities
- Carry out all aspects of upstream vector production with the goal of 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.
- 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.
- 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 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. Domestic travel requirements: 10% or less.
Physical Demands
- Regularly required to walk; use hands or fingers, handle, or feel; reach with hands and arms, talk, and hear.
- Required to stand; climb or balance; and stoop, kneel, crouch.
- Must occasionally lift and/or move up to 50 pounds.
- Specific vision abilities required 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 work at a rapid pace while maintaining attention to detail.
Work Environment
- Performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures.
- Generally performed in a sanitized laboratory setting, routinely using standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes, and computers.
- Frequently exposed to blood, viruses (e.g., HIV-1), bacteria, body fluids, and/or other tissues which may be infectious and have the potential to cause disease.
- Employees must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, face shields, glasses, and gloves.
- The noise level in the work environment is usually moderate.
Pay
The hiring range for this position is $42.99/hr - $50.60/hr, reflecting the range candidates can reasonably expect to be considered for at the time of offer, based on factors such as experience, internal equity, and qualifications. The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training.
Benefits
- Comprehensive benefits package, including health, vision, and dental insurance.
- 401(k) plan.
All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.