Talent.com
Scientist - Biopharmaceutical Pilot Registration Lab
Scientist - Biopharmaceutical Pilot Registration LabZoetis • USA, Nebraska, Lincoln
Scientist - Biopharmaceutical Pilot Registration Lab

Scientist - Biopharmaceutical Pilot Registration Lab

Zoetis • USA, Nebraska, Lincoln
30+ days ago
Job type
  • Full-time
Job description

Role Description

The Scientist in the Biopharmaceutical Pilot Registration Lab plays an essential role in the Zoetis biopharmaceutical program for veterinary medicine. As a scientist working in the Registration Lab, the individual should have technical knowledge of downstream processing for the final development, scale-up, and transfer to manufacturing for CHO expressed monoclonal antibodies. The successful candidate should have hands-on experience with recombinant protein production including centrifugation, chromatography and filtration processes. Experience associated with upstream cell culture equipment for cell growth at a 50L to 2000L scale is desired.

The successful candidate will work with minimal supervision in a GMP-regulated environment, providing strong technical support and participating in multi-disciplinary teams in close collaboration with a range of scientists and manufacturing representatives across the organization. The position is based in Lincoln (Nebraska, USA) with frequent interactions with colleagues and external partners located around the globe.

Position Responsibilities

  • Operate and troubleshoot large scale equipment for purifying recombinantly-produced therapeutic proteins
  • Develop process documentation, operating procedures, bills of materials, and protocols required for process transfer and validation. Author protocols, reports, and technology transfer documents that will support technology transfer within the company and to support regulatory filings for new product registrations. Maintain documentation and equipment records in accord with current GMPs.
  • Collaborate with downstream process development to optimize the fit of the manufacturing to the pilot and commercial manufacturing facilities.
  • Represent the pilot function on interdisciplinary project teams and serve as a liaison between product development teams and manufacturing functions. Contribute at the technical level to the direction of the team and provide information to support decision making in the realm of process scale up and transfer. -
  • Hands-on participation in the execution of GMP batches for any of the following unit operations :

downstream purification unit operations such as cross-flow filtration, centrifugation, process chromatography, precipitation, ultrafiltration, and sterile filtration

  • Support upstream activities of aseptic inoculation and growth of cultures through various vessels types and systems
  • supporting cleaning and steam-in-place activities for equipment
  • Strive for continuous improvement by streamlining existing workflows.
  • Education and Experience

  • BS in biological sciences, biosystems engineering, chemical engineering or a related field with a minimum of 1-3 years of relevant experience.
  • Practical competence in biopharmaceutical manufacturing process scale-up and tech transfer into commercial facilities.
  • Experience in executing large scale biopharmaceutical production in a GMP-regulated environment.
  • Technical Skills Requirements

  • Demonstrated practical experience and knowledge in multiple technologies for biopharmaceutical drug substance final scale-up and transfer including cell separation (continuous centrifugation / filtration), tangential and normal flow membrane filtration, and chromatography. Knowledge of CHO cell culture is desirable.
  • Working knowledge of the engineering principles covering drug substance process robustness and scale up.
  • Familiarity with instrumentation and control systems that support GMP operation of pilot scale unit operations including the capability to perform advanced troubleshooting of the processes, equipment, and environment monitoring.
  • Practical experience with automated control software and data capture systems such as SCADA, Delta V, and Unicorn.
  • Knowledge of equipment specifications, qualification, operation, and maintenance within an FDA-regulated GMP environment
  • Strong knowledge in GMP systems (change control, SAP, LIMS, etc.) is desirable
  • A willingness to work on a flexible schedule in the task to monitor experiments and equipment including after-hours work.
  • An ability to engage in work of a physical nature as encountered in pilot scale laboratory environments.
  • Excellent aseptic technique.
  • Experience with cGMPs, inspection, and compliance within biopharma manufacturing.
  • Demonstrated track record working as an independent scientific expert on multiple concurrent programs.
  • Knowledge of regulatory frameworks for veterinary biopharmaceuticals is desirable.
  • Excellent organizational and people skills
  • Excellent written and verbal communication skills.
  • Demonstrated record of working in a team environment.
  • Full time

    Regular

    Colleague

    Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

    Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved / engaged vendor but does not have the appropriate approvals to be engaged on a search.

    Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following : (1) our company website at www.Zoetis.com / careers site, or (2) via email to / from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and / or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

    About Zoetis

    At Zoetis , our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

    Global Job Applicant Privacy Notice

    Create a job alert for this search

    Scientist Scientist Pilot Registration Lab • USA, Nebraska, Lincoln

    Related jobs
    Travel EP Tech / EP Lab Tech - $1,805 to $1,978 per week in Omaha, NE

    Travel EP Tech / EP Lab Tech - $1,805 to $1,978 per week in Omaha, NE

    AlliedTravelCareers • Lincoln, Nebraska, US
    Full-time
    AlliedTravelCareers is working with AMN Healthcare Allied to find a qualified Electrophysiology Tech in OMAHA, Nebraska, 68122!. Job Description & Requirements.EEG Technologist - (EEG Tech) .Sta...Show more
    Last updated: 3 hours ago • Promoted • New!
    Illinois Licensed General Radiologist

    Illinois Licensed General Radiologist

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a Remote General Diagnostic Radiologist.Key Responsibilities Read general diagnostic radiology including Body Imaging, Musculoskeletal, Neuroradiology, Nuclear Medicine, ...Show more
    Last updated: 30+ days ago • Promoted
    Clinical Research Associate II

    Clinical Research Associate II

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a Clinical Research Associate II - Temporary.Key Responsibilities Conduct site initiation, routine monitoring, and closeout visits to ensure adherence to protocols and re...Show more
    Last updated: 30+ days ago • Promoted
    Kentucky Licensed General Radiologist

    Kentucky Licensed General Radiologist

    VirtualVocations • Lincoln, Nebraska, United States
    Part-time
    A company is looking for a part-time Remote General Radiologist.Key Responsibilities Provide general radiology services remotely on weekends Utilize AI-enhanced workflow tools and enterprise PAC...Show more
    Last updated: 30+ days ago • Promoted
    Chemistry Quality Assurance Expert

    Chemistry Quality Assurance Expert

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a Freelance Chemistry Expert - Quality Assurance (AI Trainer).Key Responsibilities Create and refine content for accuracy and relevance in Biology Assess qualification t...Show more
    Last updated: 19 days ago • Promoted
    Radiology / CT Technologist

    Radiology / CT Technologist

    Bryan Health • CRETE, Nebraska, US
    Full-time
    Performs diagnostic x-ray procedures and computerized tomography (CT) procedures under the supervision of a qualified physician. Uses x-ray and CT technology and techniques to assist in the diagnosi...Show more
    Last updated: 18 hours ago • Promoted • New!
    Senior Research Scientist

    Senior Research Scientist

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a Senior Research Scientist - Digital Biology.Key Responsibilities Developing, implementing, benchmarking, and accelerating multimodal models in digital biology and drug ...Show more
    Last updated: 30+ days ago • Promoted
    New Jersey Licensed Radiologist

    New Jersey Licensed Radiologist

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for Remote Radiologists for Evening and Overnight Shifts - 7 on / 14 off.Key Responsibilities Provide diagnostic imaging services remotely for various hospitals Collaborate ...Show more
    Last updated: 5 days ago • Promoted
    Laboratory Assistant (PRN-As Needed)

    Laboratory Assistant (PRN-As Needed)

    Bryan Health • Crete, NE, US
    Full-time
    Coordinates and performs tasks in several areas of the clinical laboratory including but not limited to phlebotomy, specimen processing and waived laboratory testing. Commits to the mission, vision,...Show more
    Last updated: 30+ days ago • Promoted
    Applied ML Scientist

    Applied ML Scientist

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for an Applied ML Scientist specializing in Model Calibration & Personalization.Key Responsibilities Fine-tune existing embeddings and learn weight calibration functions for ...Show more
    Last updated: 2 days ago • Promoted
    Texas Licensed Medical Laboratory Scientist

    Texas Licensed Medical Laboratory Scientist

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a MLS 1 Data Reviewer.Key Responsibilities Review clinical test results for accuracy and translate into LIMS Analyze raw data files and resolve routine issues Verify pa...Show more
    Last updated: 14 hours ago • Promoted • New!
    Research Technician II

    Research Technician II

    VirtualVocations • Lincoln, Nebraska, United States
    Temporary
    A company is looking for a Research Technician II to work in South San Francisco, CA.Key Responsibilities Perform protein purification, reconstitution, and structure determination of DNA-protein ...Show more
    Last updated: 16 hours ago • Promoted • New!
    Chemistry AI Trainer

    Chemistry AI Trainer

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a Freelance Chemistry Expert with Python - AI Trainer.Key Responsibilities Generate prompts that challenge AI models Define comprehensive scoring criteria to evaluate AI...Show more
    Last updated: 30+ days ago • Promoted
    Biosample Operations Specialist

    Biosample Operations Specialist

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a Biosample Operations Specialist to oversee biomarker laboratory samples for clinical trials.Key Responsibilities Plan, coordinate, and oversee operational activities fo...Show more
    Last updated: 25 days ago • Promoted
    Tennessee Licensed General Radiologist

    Tennessee Licensed General Radiologist

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a Remote Overnight General Radiologist.Key Responsibilities Interpret general diagnostic imaging, including emergency and inpatient body CT and XR Collaborate with a tea...Show more
    Last updated: 30+ days ago • Promoted
    Chemistry Quality Assurance Auditor

    Chemistry Quality Assurance Auditor

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a Freelance Chemistry Expert - Quality Assurance (AI Trainer).Key Responsibilities Create and refine content for accuracy and relevance in Biology Assess qualification t...Show more
    Last updated: 30+ days ago • Promoted
    Chemistry QA Specialist

    Chemistry QA Specialist

    VirtualVocations • Lincoln, Nebraska, United States
    Full-time
    A company is looking for a Freelance Chemistry Expert - Quality Assurance (AI Trainer).Key Responsibilities Create and refine content to ensure accuracy and relevance in Chemistry Assess qualifi...Show more
    Last updated: 2 days ago • Promoted
    Remote General Radiologist

    Remote General Radiologist

    VirtualVocations • Lincoln, Nebraska, United States
    Remote
    Full-time
    A company is looking for a Remote General Radiologist for short-term deployment opportunities.Key Responsibilities Provide diagnostic radiology services remotely or onsite as needed Manage flexi...Show more
    Last updated: 30+ days ago • Promoted