Infojini Inc | Manufacturing Associate

2 weeks ago

harmans, United States Infojini Inc Full time

Job Title – Manufacturing Associate

Location – Harmans MD 21077

Duration – 3+ months contract to hire position

Shift Hours – 12pm – 12am (2-2-3 rotation)


Job Summary:

The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing. Lifting to 40 lbs., unassisted may be required at times. Frequent standing and walking is required, as this role requires presence on the manufacturing floor. Shift work and weekend work is required.


Key Responsibilities:

Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps .Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports .May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP .Generate and revise internal and external documents (SOPs, BRs) .Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs. Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment . Recommend equipment and other supply purchases within the production areas .Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions. Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays

  • Work closely with various departments and aid other teams as necessary
  • Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
  • Participate in facility expansion and equipment validation activities


Education & Experience:

  • HS or GED with 4-7 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
  • OR
  • Associate’s degree in a Scientific, Engineering or Biotech field with 2-4 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
  • OR
  • Bachelor’s degree in a Scientific, Engineering or Biotech field with 1-3 years’ experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
  • Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
  • Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports
  • Thorough knowledge of current Good Manufacturing Practices (cGMP’s), and all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
  • Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
  • Able to fluently communicate in English. Exhibits excellent written and oral communication skills.
  • Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.


Company Overview:

Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.

  • Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States.

  • Manufacturing Associate

    2 weeks ago

    Harmans, United States Infojini Inc Full time

    Job Title – Manufacturing AssociateLocation – Harmans MD 21077Duration – 3+ months contract to hire positionShift Hours – 12pm – 12am (2-2-3 rotation)Job Summary:The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and...

  • LanceSoft, Inc. | Manufacturing Associate

    2 weeks ago

    harmans, United States LanceSoft, Inc. Full time

    Job Tittle: Manufacturing Associate Location: Harmans MD 21077 Duration: 3 months (Temp To Hire)Shift timing: 12pm – 12am (2-2-3 rotation)Job Description:The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to...

  • Manufacturing Associate

    2 weeks ago

    Harmans, United States LanceSoft, Inc. Full time

    Job Tittle: Manufacturing Associate Location: Harmans MD 21077 Duration: 3 months (Temp To Hire)Shift timing: 12pm – 12am (2-2-3 rotation)Job Description:The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to...

  • Manufacturing Supervisor

    4 weeks ago

    Harmans, Maryland, United States Catalent Inc Full time

    About Catalent Inc.Catalent Inc. is a global leader in the development and delivery of innovative medicines, committed to preserving and bettering lives.Salary RangeThe anticipated salary range for this position in Maryland is $93,280-$128,260 plus shift differential and annual bonus, when eligible.Job DescriptionOverviewWe are seeking an experienced...

  • Manufacturing Associate

    2 weeks ago

    Harmans, United States Planet Pharma Full time

    Manufacturing Support Needed- Noon-Midnight ShiftThe Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell...

  • Manufacturing Associate

    3 weeks ago

    Harmans, United States Adecco Full time

    Job DescriptionJob DescriptionAddecco is currently seeking a Manufacturing AssociatePay: $34.00/hrAssignment Type: Temp-to-Hire Shift: 12 PM – 12 AM Are you ready to advance your career in GMP manufacturing? Join our team as a Manufacturing Associate and play a vital role in upstream or downstream biologics production for Phase I/II and commercial GMP...

  • Manufacturing Associate

    1 day ago

    Harmans, United States Planet Pharma Full time

    Temp to hire, initial 3 month contractHarmans, MDShift: 12pm - 12am (2-2-3 rotation) The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk...

  • Manufacturing Associate

    2 weeks ago

    Harmans, United States Planet Pharma Full time

    Temp to hire, initial 3 month contractHarmans, MDShift: 12pm - 12am (2-2-3 rotation) The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk...

  • Manufacturing Associate

    3 weeks ago

    Harmans, United States BCForward Full time

    Job DescriptionJob DescriptionBCforward is currently seeking a highly motivated Manufacturing Associate for an opportunity in Severn, MDPosition Title: Manufacturing AssociateLocation: Severn, MD 21077Expected Duration: Temp to HireShift: 12PM to 12 AM (2-2-3 rotation)Pay: $34/hr  Job DescriptionManufacturing Associate II is responsible for supporting the...

  • Manufacturing Process Engineer

    3 days ago

    Harmans, Maryland, United States Catalent Inc Full time

    Catalent Inc is a leading contract development and manufacturing organization (CDMO) that supports the acceleration of development programs and the launch of new products. We are seeking an experienced Engineer II, MS&T to join our team in Maryland.The role involves supporting GMP manufacturing operations as a subject matter expert (SME) for biologic...

  • Biologics Manufacturing Oversight Expert

    1 week ago

    Harmans, Maryland, United States Catalent Inc Full time

    Catalent Inc. is a pioneer in contract development and manufacturing, committed to preserving and bettering lives through innovative products and services.We seek a Biologics Manufacturing Oversight Expert to join our team, providing quality assurance support for GMP manufacturing of master/working cell banks, biological bulk drug substance, and finished...

  • Planet Pharma | Manufacturing Associate

    2 weeks ago

    harmans, United States Planet Pharma Full time

    Temp to hire, initial 3 month contractHarmans, MDShift: 12pm - 12am (2-2-3 rotation) The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk...

  • Manufacturing Associate

    6 hours ago

    Harmans, United States BCForward Full time

    Job DescriptionJob DescriptionBC Forward is currently seeking a highly motivated Central Services Technician I in Severn, MD  21077Job Title: Central Services Technician ILocation: Severn, MD  21077Contract duration: 3 Months (TEMP TO HIRE)Pay Range: $21/Hr. to $23.50/hr. on W2Start Date: ASAPSchedule:  40 hours per week - Full time,  TEMP TO HIREWorker...

  • Data Management Specialist

    1 week ago

    Harmans, Maryland, United States Catalent Inc Full time

    Job OverviewCatalent Inc., a leading global contract development and manufacturing organization (CDMO), seeks an experienced Data Management Specialist to join its team. This role is responsible for the creation and management of new item set-up, bills of material, and other associated data objects in JDE ERP system.

  • Manufacturing Team Leader

    3 days ago

    Harmans, Maryland, United States Catalent Inc Full time

    Company OverviewCatalent Inc is a global leader in the drug development and delivery industry. Our mission is to preserve and better lives by advancing new medicines from early development to clinical trials and to the market.

  • Batch Disposition Expert Lead

    4 weeks ago

    Harmans, Maryland, United States Catalent Inc Full time

    Catalent Inc, a global leader in drug development and delivery, is seeking an experienced Batch Disposition Expert to join our team. This exciting opportunity allows you to utilize your knowledge of pharmaceutical manufacturing practices to ensure compliance with regulatory requirements.In this role, you will be responsible for reviewing GMP documentation...

  • Senior Quality Assurance Specialist

    1 week ago

    Harmans, Maryland, United States Catalent Inc Full time

    Catalent Inc. is a leading contract development and manufacturing organization (CDMO) dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers.As a Senior Quality Assurance Specialist at Catalent Inc., you will be responsible for providing quality assurance support for GMP manufacturing of master/working cell banks,...

  • Senior Specialist Batch Administration

    1 week ago

    Harmans, Maryland, United States Catalent Inc Full time

    OverviewCatalent Inc, a global leader in the development and manufacturing of pharmaceuticals, is seeking a Senior Specialist for its Batch Disposition team. Located on the Harmans/BWI campus, our state-of-the-art facility offers an exciting opportunity to work with cutting-edge technology and a talented team of professionals.

  • Chief Compliance Officer, Pharmaceutical Industry

    4 weeks ago

    Harmans, Maryland, United States Catalent Inc Full time

    Job OverviewCatalent Inc is a global leader in the development and manufacturing of new treatments for patients worldwide.We are seeking an experienced Senior Manager to join our Quality Assurance team in Maryland. This role will be responsible for ensuring compliance with cGMP regulations, Catalent standards, and applicable regulatory requirements.

  • GMP Operations Specialist

    1 week ago

    Harmans, Maryland, United States Catalent Inc Full time

    Catalent Inc. offers rewarding opportunities for professionals looking to advance their careers in the pharmaceutical industry.As a GMP Operations Specialist, you will play a crucial role in ensuring the quality and integrity of our products, supporting the development and manufacture of life-enhancing and life-saving treatments.The role involves a...