Manufacturing Manager

2 months ago

Piscataway, United States Global Life Science Hub Full time
Job DescriptionJob Description

Downstream Manufacturing Manager

Global Life Science Hub is recruiting on behalf of a distinguished global biopharmaceutical company for Downstream Manufacturing Manager. This dynamic role is integral to the purification of mammalian cell-based cultures and the production of recombinant proteins for a variety of mammalian-based biosimilars. The position involves purifying volumes from 50L to 1000L for engineering, clinical, and commercial batches in a cGMP environment.

The successful candidate will possess extensive technical expertise in AKTA purification skids or similar systems, tangential flow filtration (TFF), and a thorough understanding of batch records, protocols, investigations, and other technical documents.

Essential Duties & Responsibilities:

  • Perform and oversee downstream processes at various scales in a cGMP environment, including column packing, process troubleshooting, and data analysis.
  • Provide technical guidance in the execution and development of the purification process.
  • Utilize programs to collect and assess operating data, making online adjustments to products, instruments, or equipment as needed.
  • Prepare and review all quality management-related documents (Deviation, Change control, investigation reports, etc.).
  • Ensure timely execution of engineering and clinical batches.
  • Establish operating equipment specifications and enhance manufacturing techniques.
  • Collaborate with other teams and external vendors to resolve technical issues and maintain production equipment.
  • Adhere to GMP instructions in the manufacturing area and lead compliance with environmental health and safety policies.
  • Coordinate investigations and corrections for issues identified during the batch execution process.
  • Perform additional functions as required or assigned.
  • Comply with all company policies and standards.

Requirements:

  • Education: Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences with 8-12 years of related experience in the biopharmaceutical industry.
  • Prior experience in GMP and aseptic manufacturing environments.
  • Experience with AKTA Process skids or similar systems, and familiarity with single-use manufacturing consumables (e.g., bags, tube sets, columns, process manifolds).
  • Proficiency in executing engineering and clinical batches and familiarity with GMP documentation.

Work Environment & Physical Demands:

  • General work environment and physical demands necessary to perform essential functions.
  • Flexibility to work varied hours as needed.
  • Ability to work under pressure and meet deadlines.
  • Some travel may be required.

Apply

Global Life Science Hub is a specialized Life Science headhunting firm. We place professionals across Europe and the US for various Biotechnology, Pharmaceutical, and CRO companies, ranging from small start-ups to large global organizations.

If you’re interested, please apply below. If this position doesn’t suit you, visit our website for more vacancies – www.glshub.com

GLS Hub

  • Manager, Manufacturing

    4 weeks ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionSenior Manager - Manufacturing Global Life Science Hub is excited to be recruiting on behalf of a leading pharmaceutical manufacturing company located in Piscataway, New Jersey. This prestigious organization is renowned for its commitment to innovation, quality, and excellence in developing pharmaceutical dosage forms. We are...

  • Senior Manager, Manufacturing

    2 months ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionSenior Manager - Manufacturing Global Life Science Hub is excited to be recruiting on behalf of a leading pharmaceutical manufacturing company located in Piscataway, New Jersey. This prestigious organization is renowned for its commitment to innovation, quality, and excellence in developing pharmaceutical dosage forms. We are...

  • Manufacturing Senior Manager

    1 week ago

    Piscataway, New Jersey, United States Global Life Science Hub Full time

    Senior Manager - ManufacturingThe Global Life Science Hub is proud to represent a distinguished pharmaceutical manufacturing organization. This company is recognized for its dedication to innovation, quality, and excellence in the creation of pharmaceutical dosage forms. We are in search of a highly qualified and seasoned Senior Manager - Manufacturing to...

  • Manufacturing Senior Manager

    1 week ago

    Piscataway, New Jersey, United States Global Life Science Hub Full time

    Senior Manager - ManufacturingThe Global Life Science Hub is proud to present an exciting opportunity with a prominent pharmaceutical production organization. This esteemed company is recognized for its dedication to innovation, quality, and excellence in the creation of pharmaceutical dosage forms. We are in search of a highly qualified and seasoned Senior...

  • Downstream Manufacturing Operations Manager

    2 days ago

    Piscataway, New Jersey, United States Kashiv BioSciences LLC Full time

    Job SummaryKashiv BioSciences LLC is seeking a highly skilled Downstream Manufacturing Supervisor to join our team. As a key member of our manufacturing operations, you will be responsible for executing purification processes for mammalian cell-based cultures and producing recombinant proteins for a wide range of biosimilars.Key ResponsibilitiesPerform and...

  • Lead Manufacturing Operations Manager

    1 week ago

    Piscataway, New Jersey, United States Global Life Science Hub Full time

    Senior Manager - ManufacturingGlobal Life Science Hub is proud to represent a prominent pharmaceutical production organization. This esteemed company is recognized for its dedication to innovation, quality, and excellence in the creation of pharmaceutical dosage forms. We are in search of a highly qualified and seasoned Senior Manager - Manufacturing to...

  • Manufacturing Operations Leader

    2 weeks ago

    Piscataway, New Jersey, United States Ascendo Resources Full time

    Job Title: Operations ManagerPosition Overview: The Operations Manager is responsible for managing all facets of operations within a production facility. This role encompasses recruiting, training, and inspiring personnel, as well as formulating and managing manufacturing budgets, ensuring that operations align with financial constraints. The Operations...

  • Manufacturing Associate

    3 days ago

    Piscataway, New Jersey, United States Global Life Science Hub Full time

    Job OpportunityGlobal Life Science Hub is proud to partner with a leading Biopharmaceutical company that specializes in next-generation drug delivery technologies and oral/biosimilar drug development.This is an exciting time to join a rapidly expanding organization, with brand new in-house Manufacturing capabilities set to triple production in the near...

  • Senior Manufacturing Associate

    7 days ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionGlobal Life Science Hub is proud to partner with a specialised Biopharmaceutical company leading the charge of next-generation drug delivery technologies and oral//biosimilar drug development.Having gathered 2 recent FDA approvals, they're in the process of gearing up for exponential growth. With brand new in-house...

  • Manufacturing IT Systems Specialist

    3 weeks ago

    Piscataway, United States Amneal Pharmaceuticals Full time

    Description: The Manufacturing IT Systems Specialist will support both the manufacturing systems and the desktop computing environment. This role involves assisting in the implementation and maintenance of technology solutions at the manufacturing shop-floor level and providing desktop support to ensure seamless daily operations. The individual will...

  • Downstream Manufacturing Supervisor

    1 month ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionWe are recruiting a Downstream Manufacturing Supervisor for a hands-on role in the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars. The position involves handling purification volumes from 50L to 1000L for engineering, clinical, and commercial batches in a cGMP environment....

  • Downstream Manufacturing Supervisor

    4 weeks ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionWe are recruiting a Downstream Manufacturing Supervisor for a hands-on role in the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars. The position involves handling purification volumes from 50L to 1000L for engineering, clinical, and commercial batches in a cGMP environment....

  • Senior Manufacturing Technician

    2 weeks ago

    Piscataway, New Jersey, United States Global Life Science Hub Full time

    Job OverviewPosition: Downstream Manufacturing Associate IIIWe are seeking a dedicated Downstream Manufacturing Associate III to engage in the purification processes of mammalian cell-derived cultures and the production of recombinant proteins aimed at biosimilars. This role requires expertise in managing purification volumes ranging from 50L to 1000L for...

  • Senior Manufacturing Technician

    2 weeks ago

    Piscataway, New Jersey, United States Global Life Science Hub Full time

    Job OverviewPosition: Downstream Manufacturing AssociateWe are seeking a dedicated Downstream Manufacturing Associate to engage in the purification processes of mammalian cell-derived cultures and the production of recombinant proteins tailored for biosimilars. This role entails managing purification operations ranging from 50L to 1000L for various batch...

  • Downstream Manufacturing Supervisor

    2 weeks ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionGlobal Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics in the Oncology and Infectious Disease fields. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust...

  • Manufacturing Associate III

    4 weeks ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionDownstream Manufacturing Associate We are recruiting a Downstream Manufacturing Associate for a hands-on role in the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars. This position involves handling purification volumes from 50L to 1000L for engineering, clinical, and...

  • Manufacturing Associate III

    1 month ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionDownstream Manufacturing Associate We are recruiting a Downstream Manufacturing Associate for a hands-on role in the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars. This position involves handling purification volumes from 50L to 1000L for engineering, clinical, and...

  • Upstream Manufacturing Scientist

    5 days ago

    Piscataway, New Jersey, United States Global Life Science Hub Full time

    Job Description**Global Life Science Hub** is proud to partner with a specialized Biopharmaceutical company leading the charge of next-generation drug delivery technologies and oral/biosimilar drug development.**About the Company**Having gathered 2 recent FDA approvals, they're in the process of gearing up for exponential growth.With brand new in-house...

  • Downstream Manufacturing Associate III

    4 weeks ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionDownstream Manufacturing Associate IIIWe are recruiting a Downstream Manufacturing Associate III for a hands-on role in the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars. This position involves handling purification volumes from 50L to 1000L for engineering, clinical, and...

  • Downstream Manufacturing Associate III

    1 month ago

    Piscataway, United States Global Life Science Hub Full time

    Job DescriptionJob DescriptionDownstream Manufacturing Associate IIIWe are recruiting a Downstream Manufacturing Associate III for a hands-on role in the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars. This position involves handling purification volumes from 50L to 1000L for engineering, clinical, and...