Process Development Associate II (Upstream) *PC 986

Lentigen-Technology-Inc.; Gaithersburg (MD); On-site; USD 59,000 - 70,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

401(k)

Job summary

Miltenyi Biotec in Gaithersburg, MD is seeking a Process Development Associate II (Upstream) to support development, characterization, and tech transfer of processes to manufacture purified Lentiviral vectors for pre-clinical and clinical gene therapy products. The role applies adherent and suspension mammalian cell culture to production and analysis across production platforms.

You will document workflows, generate reports for process qualification, and work in a collaborative, fast-paced team.

Qualifications

• BS degree in life sciences or engineering with at least 2 years of relevant experience.
• Biotech experience preferred, especially gene therapy/virology.
• Adherent and/or suspension mammalian cell culture, transfection and harvest using aseptic techniques.
• Experience with bioreactors and DO/pH control, scale-up/down parameters.

Responsibilities

• Carry out upstream vector production to develop and qualify processes for clinical products.
• Order supplies, maintain equipment, and prepare media and buffers.
• Train team members and track data communications to ensure progress toward objectives.
• Support tech transfer to Manufacturing and process qualification through reports.

Skills

Cell culture

Upstream bioprocess

qPCR

Western blot

ELISA

Flow cytometry

Data documentation

Teamwork

Microsoft Office

JMP software

Education

B.S. degree in life sciences or engineering

Tools

Stirred-tank bioreactors

Disposable single-use bioreactors

JMP software

Job description

Process Development Associate II (Upstream) *PC 986

Showing 1 location

Gaithersburg, MD
1201 Clopper Road
Gaithersburg, MD 20878, USA

Locations

• On-site
• Manufacturing
• Full-Time

Description

Your 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. 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.
• 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.
• Domestic Travel Requirements - 10% or less

Phyiscal 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 rangerepresentsthe Company’s good faith and reasonable estimate ofpossible compensationat 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 joinMiltenyi 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.