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Process Engineer
2 weeks ago
Wolfspeed Durham, United StatesJob Summary · Materials Business is seeking a high potential, resourceful, hands-on, problem solving Process Sustaining Engineer with the capacity to quickly grasp and resolve a wide range of technical challenges. · The ideal candidate will thrive in a fast paced, deadline-orien ...
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Process Engineer
1 week ago
Cubic Durham, United StatesCubic | Nuvotronics Design for Manufacturing (DFM) Team is a multidisciplinary team of engineers, designers, and technicians who translate designs from our electrical engineering design team into buildable products. As a Process Engineer within this Process Engineer, Engineer, El ...
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Process Engineer
6 days ago
Cubic Durham, United StatesBusiness Unit:Cubic DefenseCompany Details:When you join Cubic, you become part of a company that creates and delivers technology solutions in transportation to make people's lives easier by simplifying their daily journeys, and defense capabilities to help promote mission succes ...
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Process Engineer
5 days ago
Cubic Durham, United StatesBusiness Unit: · Cubic Defense · Company Details: · When you join Cubic, you become part of a company that creates and delivers technology solutions in transportation to make people's lives easier by simplifying their daily journeys, and defense capabilities to help promote mi ...
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Process Engineer
4 weeks ago
Cree Durham, United StatesJob Summary · Materials Business is seeking a high potential, resourceful, hands-on, problem solving Process Sustaining Engineer with the capacity to quickly grasp and resolve a wide range of technical challenges. · The ideal candidate will thrive in a fast paced, deadline-orient ...
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Process Engineer
3 weeks ago
Wolfspeed Durham, United StatesJob Summary · Materials Business is seeking a high potential, resourceful, hands-on, problem solving Process Sustaining Engineer with the capacity to quickly grasp and resolve a wide range of technical challenges. · The ideal candidate will thrive in a fast paced, deadline-ori ...
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Process Engineer
1 week ago
Wolfspeed Durham, United StatesJob Summary · Materials Business is seeking a high potential, resourceful, hands-on, problem solving Process Sustaining Engineer with the capacity to quickly grasp and resolve a wide range of technical challenges. · The ideal candidate will thrive in a fast paced, deadline-ori ...
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Process Engineer
3 weeks ago
Cree Durham, United StatesJob Summary · Materials Business is seeking a high potential, resourceful, hands-on, problem solving Process Sustaining Engineer with the capacity to quickly grasp and resolve a wide range of technical challenges. · The ideal candidate will thrive in a fast paced, deadline-ori ...
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Process Engineer
2 weeks ago
Cree Durham, United StatesJob Summary · Materials Business is seeking a high potential, resourceful, hands-on, problem solving Process Sustaining Engineer with the capacity to quickly grasp and resolve a wide range of technical challenges. · The ideal candidate will thrive in a fast paced, deadline-ori ...
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Process Engineer
1 week ago
The Fountain Group Durham, United StatesThe Fountain Group is currently seeking a Process Engineer for a prominent client of ours. This position is located in Durham, NC. Details for the position are as follows: · Pay Range: $35-45/hr · Temp to perm position based on performance · 100% onsite · Job Descriptio ...
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Process Engineer
1 week ago
374Water Systems Inc Durham, United StatesJob Description · Job DescriptionLocation: This is a remote position with 80% travel to customer sites. · ARE YOU READY TO BE A PIONEER IN THE WATER INDUSTRY? · At 374Water, our mission is to preserve a clean and healthy environment that sustains life. Our revolutionary AirSCWO ...
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Process Engineer
3 weeks ago
The Fountain Group Durham, United StatesJob Description · Job DescriptionThe ideal candidate possesses experience in Biomanufacturing with an Engineering mind. You will play a critical supportive role to the Engineering team in creating and refining processes in order to improve manufacturing safety, quality, and produ ...
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Process Engineer
4 days ago
Micross Durham, United StatesSummary:We are seeking a knowledgeable, self-motivated individual for our growing operations team which will support processing in a dynamic production and R&D environment. This position will focus on supporting advanced packaging processing and process development, for, but not ...
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Process Engineer
2 weeks ago
374Water Systems Inc Durham, United StatesJob Description · Job DescriptionLocation: Candidates may be remote anywhere within the United States with 80% travel to customer sites. · ARE YOU READY TO BE A PIONEER IN THE WATER INDUSTRY? · At 374Water, our mission is to preserve a clean and healthy environment that sustains ...
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Process Engineer
4 days ago
Micross Durham, United StatesSummary: · We are seeking a knowledgeable, self-motivated individual for our growing operations team which will support processing in a dynamic production and R&D environment. This position will focus on supporting advanced packaging processing and process development, for, but ...
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Process Engineer
2 weeks ago
Micross Components Durham, United StatesJob Description · Job DescriptionSummary: · We are seeking a knowledgeable, self-motivated individual for our growing operations team which will support processing in a dynamic production and R&D environment. This position will focus on supporting advanced packaging processing an ...
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Senior Process Engineer
4 weeks ago
The Clorox Company Durham, United StatesClorox is the place that's committed to growth – for our people and our brands. Guided by our purpose and values, and with people at the center of everything we do, we believe every one of us can make a positive impact on consumers, communities, and teammates. Join our team. #Clo ...
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Process Engineer II
1 week ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
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Process Engineer II
2 weeks ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
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Senior Process Engineer
2 weeks ago
Asklepios Biopharmaceutical Durham, United StatesAsklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicin ...
Senior Process Engineer - Durham, United States - Asklepios Biopharmaceutical
Description
Asklepios BioPharmaceutical, Inc.(AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD.
Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we've built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology.Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson's disease, and congestive heart failure.
Our gene therapy platform includes Pro10TM, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform.
Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.Our vision:
Pioneering science to create transformative molecular medicines
Our mission:
Lead innovative science and drive clinical outcomes to transform people's lives
Our principles:
Advance innovative science by pushing boundaries.
Bring transformative therapeutics to patients in need.
Provide an environment for employees to reach their fullest potential.
Our values:
Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.
Position Overview AskBio is seeking a Manufacturing Science and Technology (MSAT) Senior Process Engineer to join our Process Engineering team and support current and future commercialization efforts.
This position supports scale-up, technology transfer of AskBio's portfolio of gene therapy products into cGMP manufacturing for clinical production, process validation and commercial launch.
The incumbent will onboard clinical programs into the MSAT laboratory, perform scale-up runs, and transfer programs to AskBio's contract manufacturing facility.
Additionally, this position will be responsible for performing Phase III clinical activities including scale-down model development and qualification, process characterization, and process control strategy definition to enable process performance qualification (PPQ) readiness for both drug substance and drug product manufacturing campaigns.
This position is highly collaborative and will require internal and external team interactions to ensure successful process scale-up, technology transfers, and cGMP manufacturing operations to ensure continuity of supply while adhering to global regulations and standards.
This role is based on-site at our RTP (Research Triangle Park) Headquarters in NC.ResponsibilitiesCollaborate with cross-functional teams to transfer all unit operations of a gene therapy processes from Process Development into the MSAT laboratory and cGMP production to demonstrate successful knowledge transfer.
Apply Design of experiment (DOE) methodology to execute and analyze experiments to optimize one or more process steps with limited oversight.
With limited oversight, design and execute risk-based process characterization studies to improve product yield, quality, scalability and define the process control strategy for PPQ.Author technical protocols and reports to support experimental work while maintaining organized electronic laboratory notebooks.
Develop and qualify small-scale models that are predictive of clinical manufacturing.Upstream and/or downstream biomanufacturing experience with a technical understanding of cGMP manufacturing operations.
Author groups of technical protocols and reports to support experimental work while maintaining organized electronic laboratory notebooks.
Provide effective communication of experimental results in technical presentations with internal and external stakeholders with limited leadership oversight.
JMP Statistical Software familiarity.
Experience contributing to one or more PPQ/Process Validation campaigns.
Familiarity with the requirements of a Continuous Process Verification Campaign including trending, and annual reporting.
Lead cross-functional investigations into process deviations by employing robust quality risk management methodologies to guide resolution and corrective actions, leveraging a data- driven approach.
Recommend and/or drive CAPAs as needed.Awareness of regulatory guidance's and submission document structure.
Familiarity with audit and inspection practices.
Experience contributing to cross-functional collaborations to improve business processes.
Ensure the laboratory is clean, organized and maintained in an efficient working order. Schedule and execute routine preventative maintenance/calibration of instruments/equipment. Plan supplies and materials for experiments and support proper scheduling of laboratory work.
RequirementsMaster's Degree in Biology, Chemistry, Biochemistry, Chemical Engineering or related field and 3+ years of Biopharmaceutical Experience, or Bachelor's Degree in Biology, Chemistry, Biochemistry, Chemical Engineering or related field and 5+ years of Biopharmaceutical Experience.
Upstream and/or downstream biomanufacturing experience with a technical understanding of cGMP manufacturing operations.Familiarity with JMP Statistical Software and Design of Experiments (DOE).Excellent communication skills, with the ability to collaborate cross-functionally and present technical information clearly and concisely.
Excellent problem-solving and analytical skills, with the ability to troubleshoot complex technical issues.Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint).Able to travel, domestic and international, up to ~10%.Preferred ExperienceProficiency with the Design of experiment (DOE) methodology using JMP Statistical Software to design, execute, analyze, and interpret experiments independently is highly preferred.
Prior experience contributing to one or more PPQ/Process Validation campaigns.Familiarity with the requirements of a Continuous Process Verification Campaign including trending, and annual reporting.
Awareness of regulatory guidance's and submission document structure.
Prior experience supporting regulatory audits and inspections.
The ideal candidate will beA motivated, organized, and disciplined individual who strives to be part of a best in-class, collaborative tech transfer team.
Able to multitask among multiple projects and teams, and enjoys working in a fast-paced, highly interactive environment.An individual with a continuous improvement mindset, and who aims to optimize process operations and performance via ability to seek out solutions.
Asklepios BioPharmaceutical, Inc.(AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws.
All employment decisions are based on valid job-related requirements.If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at or sending us an email at Please do not contact any employee at AskBio about this requisition.
Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position.
All agencies must have a prior executed service agreement with AskBio prior to any search engagement.If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.
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