Upstream Process Development Lead

3 weeks ago

Frederick, United States ClinLab Staffing Full time

Upstream Process Development Lead—Frederick, MD

Responsibilities:

• Participate in or lead development of robust and scalable upstream mammalian cell culture

processes for biologics in different stages of clinical development.

• Advance upstream processes by improving efficiency and cost effectiveness through research

and innovation, while assessing technologies and industry best practices.

• Participate in or lead internal manufacturing activities: technical transfer and manufacturing

support.

• Participate in or lead external development and manufacturing activities at external partners:

development work, technical transfer, and manufacturing support.

• Participate in or lead process validation activities for successful commercialization.

• Contribute to strategic initiatives; partner with senior leaders to set overall project strategy,

and guide teams towards its execution.

• Mentor and actively share expertise and build strong collaborative relation.

Required Experience and Skills:

• Strong fundamental knowledge and subject matter expertise in cell-culture process

development for biologics, perfusion and fed-batch cell culture, bioreactors across scales, as

well as recent advances, and challenges in the field.

• Expertise in independently conducting and directing the design, execution, analysis, and

documentation of all stages of cell-culture process development.

• Operation of Repligen ATF systems.

• Operation of XDR and BioBlu bioreactors.

• Operation of AMBR high-throughput bioreactor systems.

• Operation of NovaFlex, ViCell Blu and other analytical instruments.

• Familiar with DoE principles and its use in process development, optimization and

characterization.

• Strong troubleshooting skills, including overcoming difficult process challenges and

manufacturing implementation.


Preferred Experience:

• Experience with NS0 cell lines, Catalent’s GPEx® technology with GS knock-out CHO cell

line and Lonza’s CHO GS Exceed® Gene Expression system.

• Track record of accomplishments in upstream bioprocessing.


Minimum Qualifications:

• Bachelor degree in biochemical engineering or life sciences.

• Hands-on experience in mammalian cell culture process development.

• Strong attention to detail.

• Must be organized and self-motivated.

• Excellent time management and proven ability to complete projects on time.

• Excellent level of initiative, creativity, and quest for knowledge.

• Must have excellent communication and writing skills

• Familiarity with Microsoft Office (Word, Excel and Powerpoint etc.)

  • Upstream Process Development Lead

    3 weeks ago

    Frederick, United States ClinLab Staffing Full time

    Upstream Process Development Lead—Frederick, MD Responsibilities:• Participate in or lead development of robust and scalable upstream mammalian cell cultureprocesses for biologics in different stages of clinical development.• Advance upstream processes by improving efficiency and cost effectiveness through researchand innovation, while assessing...

  • Technical Writer

    3 weeks ago

    Frederick, United States eTeam Full time

    Title: Technical Writer (Manufacturing)Location: Frederick, MD 21703Duration: 12 monthPay Rate: $54.00Position Overview :At Client, we work together across global boundaries to make an impact and find answers to challenges. This is a truly exciting period for us at Client. We have a pipeline that presents outstanding opportunities to push the boundaries of...

  • Technical Writer

    3 weeks ago

    Frederick, United States eTeam Full time

    Title: Technical Writer (Manufacturing)Location: Frederick, MD 21703Duration: 12 monthPay Rate: $54.00Position Overview :At Client, we work together across global boundaries to make an impact and find answers to challenges. This is a truly exciting period for us at Client. We have a pipeline that presents outstanding opportunities to push the boundaries of...

  • Technical Writer

    3 weeks ago

    Frederick, United States Unicon Pharma Inc Full time

    Job DescriptionJob DescriptionPosition Overview:At Client, they work together across global boundaries to make an impact and find answers to challenges. This is a truly exciting period for us at Client. They have a pipeline that presents outstanding opportunities to push the boundaries of science to deliver medicines to patients which will positively impact...

  • Physical Therapist

    7 days ago

    Frederick, United States Integrity Rehab Group Full time

    Integrity Rehab Group is an industry leading therapy management company that partners with physician practices across the nation. In partnering with Frederick Primary Care Associates we have become a preferred outpatient orthopedic therapy service provider to the Frederick, MD community. To further support the needs of this community we are looking to add a...

  • Manufacturing Technician

    3 months ago

    Frederick, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFrederick, MDContract Duration: 6-36 monthsResponsibilities:Excellent employment opportunity for a Manufacturing Technician in the Frederick, MD area.Operation of upstream / downstream / central services processing equipment according to established SOPs. This equipment includes but is not limited to bioreactors, TFF skids,...

  • Manufacturing Technician

    3 months ago

    Frederick, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFrederick, MDContract Duration: 12-36 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Manufacturing Technician in the Frederick, MD area.Qualified in Prod Technician dutiesOperation of upstream / downstream / central services processing equipment according to established SOPs. This equipment...

  • Manufacturing Technician

    3 months ago

    Frederick, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFrederick, MDContract Duration: 6-36 monthsResponsibilities:Excellent employment opportunity for a Manufacturing Technician in the Frederick, MD area.Operation of upstream / downstream / central services processing equipment according to established SOPs. This equipment includes but is not limited to bioreactors, TFF skids,...

  • Manufacturing Technician

    3 months ago

    Frederick, United States Fladger Assoc. Inc. Full time

    Job DescriptionJob DescriptionFrederick, MDContract Duration: 12-36 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Manufacturing Technician in the Frederick, MD area.Qualified in Prod Technician dutiesOperation of upstream / downstream / central services processing equipment according to established SOPs. This equipment...

  • Process Improvement Engineer

    5 days ago

    Frederick, Colorado, United States Gable Search Group Full time

    Job DescriptionQuality EngineerJob OverviewGable Search Group is seeking a highly skilled Quality Engineer to join our team. As a Quality Engineer, you will play a critical role in ensuring the quality of our products and processes.The Role:Our Quality Engineer will work closely with cross-functional teams to monitor and improve the quality of our processes...

  • Physical Therapist

    6 days ago

    Frederick, United States Integrity Rehab Group Full time

    Job DescriptionIntegrity Rehab Group is an industry leading therapy management company that partners with physician practices across the nation. In partnering with Frederick Primary Care Associates we have become a preferred outpatient orthopedic therapy service provider to the Frederick, MD community. To further support the needs of this community we are...

  • Physical Therapist

    6 days ago

    Frederick, United States Integrity Rehab Group Full time

    Integrity Rehab Group is an industry leading therapy management company that partners with physician practices across the nation. In partnering with Frederick Primary Care Associates we have become a preferred outpatient orthopedic therapy service provider to the Frederick, MD community. To further support the needs of this community we are looking to add...

  • Physical Therapist

    1 week ago

    Frederick, United States Integrity Rehab Group Full time

    Integrity Rehab Group is an industry leading therapy management company that partners with physician practices across the nation. In partnering with Frederick Primary Care Associates we have become a preferred outpatient orthopedic therapy service provider to the Frederick, MD community. To further support the needs of this community we are looking to add a...

  • Manufacturing Technical Writer

    4 weeks ago

    Frederick, United States The Fountain Group Full time $40 - $50

    Job DescriptionJob DescriptionOverview:·         We need someone with Biologics Manufacturing experience who is familiar with cell culture processing. Experience with Electronic Batch Records (like PAS|X) is a plus.·         Responsible for creating technical instruction documents including standard operating procedures (SOPs), explaining...

  • Data Processing

    4 weeks ago

    Frederick, United States Navistar Direct Marketing Full time

    Job DescriptionJob DescriptionMoore is a data-driven constituent experience management (CXM) company achieving accelerated growth for clients through integrated supporter experiences across all platforms, channels, and devices. We are an innovation-led company of 5,000 people that is the largest marketing, data, and fundraising company in North America...

  • Adjunct, Sterile Processing

    3 months ago

    Frederick, United States InsideHigherEd Full time

    Adjunct Job Title:Adjunct, Sterile ProcessingAdjunct Job Description:Position Summary:This position supports the Sterile Processing Technician Training program under the Continuing Education and Workforce Development Healthcare Careers Department. The adjunct instructor prepares students for the International Association of Healthcare Central Service...

  • Manufacturing Operations Specialist

    3 days ago

    Frederick, Maryland, United States Fladger Assoc. Inc. Full time

    Job SummaryFladger Assoc. Inc. is seeking a highly skilled Manufacturing Operations Specialist to join our team. As a key member of our production team, you will be responsible for operating and maintaining complex process equipment, ensuring compliance with current Good Manufacturing Practices (cGMPs), and providing training to colleagues.Key...

  • Production Equipment Specialist

    2 weeks ago

    Frederick, Maryland, United States Fladger Assoc. Inc. Full time

    Job OverviewFladger Assoc. Inc. is seeking a skilled Manufacturing Technician to support our operations. This role involves working with various processing equipment and ensuring compliance with industry standards.Key Responsibilities:Operate and maintain upstream, downstream, and central services processing equipment following established protocols.Utilize...

  • Production Equipment Specialist

    1 week ago

    Frederick, Maryland, United States Fladger Assoc. Inc. Full time

    Position OverviewFladger Assoc. Inc. is seeking a dedicated Manufacturing Technician to contribute to our operations. This role is essential for maintaining the efficiency and effectiveness of our production processes.Key Responsibilities:Operate and maintain various processing equipment in compliance with established standard operating procedures...

  • Cell Processing Specialist

    3 weeks ago

    Frederick, United States Net2Source Inc. Full time

    Job Title: Cell Therapy Specialist I* Location: Frederick, Maryland, 21704 Duration: 12+ Months (Extendable) Pay Rate: $34/hr on W2 Job ID: GILDJP00015534 IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7...