Process Development Scientist (Analytical Method Development) *PC 403
Miltenyi Biotec.com
108k - 118k USD/year
Office
Gaithersburg, Maryland, United States
Full Time
Your Role:
This position is primarily responsible for identifying, testing, and implementing processes and analytical methods.
The role will drive the overall activities related to proper execution of technologies being evaluated. The scientist is experienced in Analytical Method technologies and will drive complete evaluation of work related to overall goals. The scientist may oversee the activities of associates and senior associates.
Essential Duties And Responsibilities:
- Work on projects of complex scope in which analysis of data requires evaluation of identifiable factors, troubleshooting, and proposal of solutions that lead to implementation of new processes and methods, with oversight from senior personnel.
- Instrumental in the development of analytical methods, and/or scalable processes for the production, characterization, and release of cell and gene therapy substance and products.
- Continuous monitoring of existing approved methods, to include troubleshooting, and propose alternative suitable technologies for improvement.
- Lead design and execution of assays to characterize Lentiviral vector.
- Execute viral vector transduction assays and other assays for characterization of vector.
- Help to identify process gaps and develop process analytical methods for evaluating product quality.
- Experience in method qualification and characterization.
- Tech transfer of developed processes to QC department.
Requirements:
- Ph.D. in Biology/Life Sciences, Chemistry, or Chemical Engineering with a minimum of 2 years of experience in analytical method development, or a Master’s degree in the same fields with at least 6 years of relevant experience. A combination of education and experience may also be accepted.
- Previous experience producing and/or characterizing viral vectors is desired.
- In-depth knowledge of FDA, EMA, GMP, and ICH regulatory requirements is desired.
- Analytical problem-solving skills with impeccable attention to detail.
- Excellent communication, interpersonal, and collaborative skills.
- Must be able to interact with R&D, Manufacturing, MSAT, and QC.
- Must be able to communicate professionally with external vendors and clients.
- Ability to collaborate and build a consensus in a high-pressure environment.
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, 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 such as scrubs, coveralls, masks, glasses and gloves. The noise level in the work environment is usually moderate.
The hiring range for this position is expected to fall between $108,400- $117,950/year, reflecting the range candidates can reasonably expect to be considered for at 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. The above range represents the Company’s good faith and reasonable estimate 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, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional 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. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. 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.
Process Development Scientist (Analytical Method Development) *PC 403
Office
Gaithersburg, Maryland, United States
Full Time
108k - 118k USD/year
October 9, 2025