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Associate Downstream Process Development Scientist Jobs in Ohio

Owens Corning

Advanced Scientist

Granville, OH · On-site

PURPOSE OF THE JOB The Product Development Scientist will be part of the Product Development team ... Manage projects utilizing the Stage-Gate process and project management tools * Partner with ...

Owens Corning

Advanced Scientist

Granville, OH

PURPOSE OF THE JOB The Product Development Scientist will be part of the Product Development team ... Manage projects utilizing the Stage-Gate process and project management tools * Partner with ...

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All JobsAssociate Downstream Process Development Scientist JobsAssociate Downstream Process Development Scientist Jobs in Ohio

Associate Downstream Process Development Scientist information

What is an Associate Downstream Process Development Scientist?

An Associate Downstream Process Development Scientist is a professional who works in the biotechnology or pharmaceutical industry, focusing on developing and optimizing processes that purify biological products, such as proteins or antibodies, after they have been produced by cells. Their work is crucial for ensuring the final product meets quality and safety standards before it is used in research or clinical applications. They typically perform laboratory experiments, analyze data, and collaborate with other scientists and engineers to improve yield and efficiency. This role is often entry-level or early-career, providing hands-on experience in process development and technical troubleshooting.

What are the key skills and qualifications needed to thrive as an Associate Downstream Process Development Scientist, and why are they important?

To excel as an Associate Downstream Process Development Scientist, you need a solid understanding of biochemistry, chemical engineering, and downstream purification techniques, often supported by a bachelor's or master's degree in a life science or engineering discipline. Familiarity with chromatographic systems (such as AKTA), filtration equipment, and analytical tools, as well as knowledge of GMP/GLP regulations, is typically required. Strong problem-solving, attention to detail, and effective teamwork and communication skills help you navigate complex experiments and collaborate with cross-functional teams. These skills ensure efficient process optimization, compliance with regulatory standards, and successful development of biopharmaceutical products.

What is the difference between Associate Downstream Process Development Scientist vs Associate Upstream Process Development Scientist?

AspectAssociate Downstream Process Development ScientistAssociate Upstream Process Development Scientist
Primary FocusPurification and recovery of bioproductsCell culture and fermentation processes
Required SkillsProtein purification, chromatography, filtrationCell culture, bioreactor operation, media preparation
Work EnvironmentLaboratories, manufacturing facilitiesLaboratories, bioreactor labs
Common CertificationsBiotech or bioprocessing certificationsBiotech or bioprocessing certifications

Both roles are essential in biopharmaceutical development, focusing on different stages of the production process. The Associate Downstream Process Development Scientist specializes in purification techniques, while the Associate Upstream Process Development Scientist concentrates on cell growth and fermentation. Understanding these distinctions helps candidates target their skills and career paths effectively.

What are some typical challenges faced by an Associate Downstream Process Development Scientist, and how can they be addressed?

Associate Downstream Process Development Scientists often encounter challenges such as optimizing purification processes, troubleshooting equipment performance, and ensuring batch-to-batch consistency. These challenges can be addressed by maintaining meticulous documentation, collaborating closely with upstream and analytical teams, and staying current with best practices in chromatography and filtration. Proactively seeking feedback from experienced colleagues and participating in cross-functional meetings can also help in identifying solutions and improving process efficiency.
What are the most commonly searched types of Downstream Process Development Scientist jobs in Ohio? The most popular types of Downstream Process Development Scientist jobs in Ohio are:
What cities in Ohio are hiring for Associate Downstream Process Development Scientist jobs? Cities in Ohio with the most Associate Downstream Process Development Scientist job openings:
Associate Downstream Process Development Scientist jobs near you
Senior GMP Technician, Downstream

Senior GMP Technician, Downstream

Forge Biologics

Columbus, OH • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 29 days ago

Job description

Forge Your Future with Us:
At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.
Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen - you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.
What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.
At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us.
If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself.
About The Role:
We are seeking an experienced and highly skilled individual to join our Downstream Manufacturing team. As a Senior Technician, GMP Manufacturing - Downstream you will play a pivotal role in the purification and processing of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. Your expertise in downstream bioprocessing and strong leadership abilities will contribute to the success of our manufacturing operations and the delivery of cutting-edge gene therapies that have the potential to transform the lives of patients.
Responsibilities:
  • Lead and execute downstream manufacturing operations, including but not limited to chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps, according to Standard Operating Procedures (SOPs) and batch records.
  • Independently prepare, operate, and troubleshoot advanced downstream equipment, such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring optimal performance and compliance.
  • Monitor critical process parameters during manufacturing operation, analyze data, and proactively identify and address deviations or abnormalities, ensuring timely reporting and resolution.
  • Perform in-process testing and quality control checks, such as pH, conductivity, pressure measurements, and other analytical techniques to ensure product quality and compliance with specifications.
  • Lead and document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies.
  • Collaborate closely with cross-functional teams, including Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents, ensuring compliance with regulations and meeting production timelines.
  • Drive process improvements by evaluating new technologies, equipment, and methods, and leading the implementation of strategies to enhance manufacturing efficiency, productivity, and compliance.
  • Mentor and train junior team members, providing guidance on process execution, troubleshooting, and adherence to cGMP guidelines.
  • Ensure the highest standards of safety procedures and environmental health and safety guidelines are followed, maintaining a safe working environment.
  • Stay updated with the latest advancements in gene therapy downstream manufacturing processes, regulatory requirements, and industry trends, and actively contribute to the continuous improvement of manufacturing practices.

Qualifications:
  • Bachelor's Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience).
  • Prior experience working in a GxP or regulated environment.
  • Downstream processing or biologics manufacturing experience.
  • Extensive expertise and hands-on experience with downstream processing techniques and equipment, such as chromatography systems, filtration systems, centrifuges, and TFF systems.
  • Proficiency in conducting in-process testing and quality control checks to ensure product quality and compliance..
  • Excellent attention to detail and ability to accurately document and record experimental data and manufacturing activities.
  • Strong organizational skills and the ability to manage multiple tasks, prioritize effectively, and meet project timelines in a fast-paced environment.
  • Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
  • Demonstrated leadership abilities, including experience in mentoring and training junior team member.
  • Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules.
  • Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.

Preferred Skills:
  • Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.
Work Environment and Physical Demands
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We've Got You Covered:
At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We've built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one
  • Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.

Time to recharge
  • A competitive paid time off plan - because rest fuels innovation.
  • 12 weeks of fully paid parental leave so you can focus on family when it matters most.

Rewarding your impact
  • Annual bonus opportunities for all full-time team members.
  • 401(k) with company match to help you plan for the future.
  • Special employee discounts, including childcare and dependent care savings.

Your wellness, supported
  • Onsite fitness facility at The Hearth.
  • Mental health counseling and financial planning services through our Employee Assistance Program.
  • Employer-paid short and long-term disability coverage to protect your peace of mind.

Fuel for your workday
  • A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.

Grow with us
  • Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

Apply