Process Development Associate II (Downstream) *PC 411

Miltenyi Biotec; Gaithersburg (MD); On-site; USD 59,000 - 70,000; Full time

Benefits offered by this job

Health, vision, and dental insurance

401(k) plan

Job summary

Miltenyi Biotec in Gaithersburg, MD is seeking a Process Development Associate II (Downstream) to contribute to the development of site-specific products and processes with limited supervision.

You will perform downstream operations, prepare materials, run experiments, and document results while collaborating with cross-functional teams. The role offers an on-site, full-time position with competitive benefits and opportunities to influence process improvements.

Qualifications

• Degree in life sciences with at least 2 years of relevant experience.
• Experience in protein purification and scale-up principles.
• Experience with column chromatography, filtration, and related downstream technologies.
• Experience with AKTA systems.
• Prepare solutions for production; perform lab-scale and pilot-scale experiments.
• Strong documentation and ability to draft SOPs/BPRs.

Responsibilities

• Perform downstream operations independently or with minimal supervision.
• Prepare materials for downstream activities (buffers, packed columns, filters).
• Execute experiments designed by senior team members.
• Maintain complete and detailed lab notebooks and documentation.
• Contribute to process improvements and troubleshoot methods.
• Train junior team members in current responsibilities.
• Assist in manufacturing documentation with limited scope and oversight.
• Support manufacturing of materials for commercial and pre-clinical studies.
• Carry out ongoing experiments and runs in PD.

Skills

Protein purification knowledge

Scale-up principles

Chromatography techniques

Laboratory documentation

Cross-functional collaboration

Microsoft Office

QbD software

JMP software

Education

Bachelor's degree in Life Sciences

Tools

AKTA chromatography systems

Job description

Process Development Associate II (Downstream) *PC 411

Locations

Showing 1 location

Gaithersburg, MD 20878, USA

• On-site
• Manufacturing
• Full-Time
• Requisition #: PROCE003689

Description

Your Role:

This position is primarily responsible for performing routine tasks related to the development of site-specific products and/or processes with limited supervision. This position will also support the technical needs of the department as they relate to site specific products and/or processes. Duties and level of responsibility will be based on previous experience and demonstrated ability to provide consistent results.

Essential Duties and Responsibilities:

• Responsible to perform downstream operations independently or with minimal supervision.
• Responsible for preparing necessary materials (buffer, packed columns, filters) in support of downstream activities.
• Execute experiments, with minimal supervision, designed by senior team members.
• Responsible for the proper use of equipment and perform cleaning of the equipment as required.
• Maintain complete and detailed lab notebooks and other documentation.
• Contribute to evaluation and implementation of process improvements (process troubleshooting, evaluating new methods, techniques).
• Participate in department and team meetings and reports on status.
• Assist and may independently execute assays to characterize processes such as (ELISA, qPCR, ddPCR, Flow Cytometry, SDS-page, Western Blot, Total protein and DNA,etc...).
• Complete Purchase Order requests and restock supplies as needed to maintain inventory of critical reagents and materials, may be required to work cross-functionally.
• Train junior team members in all aspects of current responsibilities, with direction from senior team members.
• May assist in the development of manufacturing documentation with limited scope, and full oversight from senior team members.
• As needed, support and perform necessary operations to manufacture materials needed for commercial and collaborator evaluation and pre-clinical studies, including assembly and sterilization of single-use materials.
• Assist on projects of moderate scope, with execution of pre-defined test variables supervised.
• Perform necessary operations to maintain laboratory infrastructure.
• Carry out tasks in support of on-going experiments and runs in PD.

Requirements:

• Degree in the life sciences with at least 2 years of relevant experience.
• Scientific understanding of protein purification technologies and ability to learn and explore new approaches to improve existent processes. Understand and apply scale-up principles and strategies.
• Experienced in protein and/or viral particle purification methods that include cell culture supernatant harvest and clarification, column/membrane chromatography (AEX, CEX, affinity, HIC, mixed-mode, and SEC), filtration technologies (UF/DF, Dead-end, etc.)
• Experience with operating AKTA Systems or similar chromatography systems.
• Prepare solutions required for production
• Perform lab-scale and/or pilot-scale experiments to support process development and optimization of different unit operations (filtration, chromatography)
• Interact with upstream and analytical functional teams to determine appropriate method for protein purification
• Actively engage in scientific and technical discussions
• Draft and execute SOPs, BPRs
• Superb documentation and organizational skills, often providing summaries and generating development reports
• Highly proficient in the use of Microsoft Office products
• Experience with late-stage product development as well as the statistical design of experiments is a plus
• Experience with upstream techniques and performing analytical assays is a plus
• Experience with QbD and 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 or 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.

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 (e.g., HIV-1), bacteria, body fluids and/or other tissues which may be infectious and have the potential to cause disease. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, face shield, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $42.99/hr - $50.60/hr, 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 is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.

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.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.