| Job List |
| Job ID: |
PS-07076-10 - Senior Quality Engineer |
| Description: |
Bonus/Incentives: Yes
Stock Options: Unknown
Relocation: No
Dress: Business Casual Is travel required:
Primary Responsibilities: Working individually or in a team environment identifies and and puts into place corrective actions to address potential or actual process failures(equipment, procedural, people or materials). The key role of the position is to ensure that throughout a product's lifecycle (development through commericalization) quality is designed into products by understanding and controlling the processes used to manufacture and test the product. Assumes responsibility for the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives. Key interactions and interfaces are with Production Management, Project Team Leaders and team members, QA/QC, Pharmaceutical Technology Operations, Purchasing and material/component/equipment suppliers. Serves as a mentor to staff members on the use of quality tools and measures.
Technical Knowledge: ASQ Certified Quality Engineer
Degree Required: Yes
Degree Type: BA/BS
Major: Engineering, Math or Science
Yrs Experience: 5-7 Years
Experience Preferred: Requires 5 years experience as a Quality Engineer in a cGMP environment and leadership skills to enable them to take the lead. Prefer experience in pharmaceutical tablet manufacturing or tablet development. KT problem solving certification,Lean Manufacturing/Six Sigma Training, Supplier Certification. Advanced degree in Engineering, Science or Math
Background Checks Required:
FDA Debarment
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Salary: $65 - $80K,
Job Type: Permanent,
Total Exp: 5-7 years,
Start Date: ASAP,
Location: Davie, FL |
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| Job ID: |
DS-08307-1 - Sr. QC Specialist |
| Description: |
This Company, located in Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer.
They offer a wide-range of opportunities for highly motivated employees, who set their goals high, will find that the rewards may exceed their expectations. Their vision for a bright and prosperous future sets the stage for energetic, creative professionals to join us and contribute to our success. They currently employ individuals with a variety of backgrounds including scientific, clinical research, manufacturing and regulatory. Their growth depends on developing and energizing the talents of new and current employees.
Primary Responsibilities:
Perform lot release and stability testing of antibodies/proteins/vaccines.
Technical writing of documents such as SOPs, OOS investigation reports, assay qualification and validation reports, and assay transfer protocols and summary reports.
Maintain and implement cGMP work practices in the QC laboratory.
Hands on experience with RP-HPLC, size exclusion-HPLC and other spectroscopic test methods.
Monitor product lot release and stability testing cycle times and laboratory investigation reports and corrective/preventative actions.
Secondary Responsibilities:
Review test results and laboratory notebooks prior to approval.
Develop protocols and reports for antibodies and biologicals.
Prepare stability trend charts, reports and continually update the team and Director, Quality Control and Analytical Development.
Requirements:
BA/BS degree in Analytical Chemistry.
Experience in Biologicals Quality Control laboratories that includes 7 or more years associated with:
Monoclonal antibodies and recombinant technology-derived protein testing.
Out of specification investigations and laboratory investigations of bio-analytical test results.
Demonstrated competency in technical writing including SOPs, analytical method qualification/validation reports, etc.
Performance of stability indicating test methods.
Experience in writing specifications with appropriate rationale.
Hands on experience with HPLC test methods for antibodies and antibody drug conjugates.
ICH guidelines for stability studies
Knowledge of GMPs as they relate to laboratory operations.
Attentive to details; strong communication and writing skills; team-oriented; comfortable with direction from Directors and peers.
Identify and implement continuous improvement of cGMP compliance issues in the QC lab.
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Salary: 50-60k,
Job Type: Permanent,
Total Exp: 7-10 Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
DS-09247-1 - Sr. Scientist, QC/Analytical Development |
| Description: |
This Company, located in Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer.
They offer a wide-range of opportunities for highly motivated employees, who set their goals high, will find that the rewards may exceed their expectations. Their vision for a bright and prosperous future sets the stage for energetic, creative professionals to join us and contribute to our success. They currently employ individuals with a variety of backgrounds including scientific, clinical research, manufacturing and regulatory. Their growth depends on developing and energizing the talents of new and current employees.
Currently seeking a Senior Scientist, QC/Analytical Development
Primary Duties:
Development, optimization, and performance of characterization assays designed to establish the primary, secondary and tertiary structure of antibodies.
Technical writing of documents such as SOPS, investigation reports, assay development and validation reports, and assay transfer protocols and summary reports.
Interact with contract laboratories to establish service agreements, review assay transfer and validation protocols, review and approve characterization test results, and support investigation or trouble-shooting activities as needed.
Development, optimization and performance of LC-MS and spectroscopic test methods to establish the conformational aspects and structure-function relationships of antibodies.
Maintenance of Mass Spectrometry laboratory and training of other staff members on LC-MS applications.
Secondary Duties:
Review test results and laboratory notebooks prior to approval.
Develop protocols for antibody characterization and comparability studies.
Preparation and participation in project management activities related to product team meetings.
Provide backup support to Director, Analytical Development.
Requirements:
Requires a Ph.D. in Analytical Chemistry or Protein Chemistry
Experience in Biological analytical development laboratories that includes 5 or more years associated with:
Monoclonal antibodies and recombinant technology-derived protein product development.
Development, transfer, and qualification of new analytical methods in protein chemistry and antibody chemistry.
Demonstrated competency in the technical writing including SOPs, analytical method development/antibody characterization reports, etc.
Performance of standard physico-chemical and conformational methods for the characterization, and degradation pathway studies of clinical trial product lots.
Hands on experience with LC-MS and ion-exchange, hydrophobic and reversed phase chromatographic test methods for antibodies.
Knowledge of the GMPs as they relate to manufacturing and the Quality unit.
Attentive to details; strong communication and coaching skills; team-oriented; comfortable with direction from Directors and peers.
Identify and implement continuous improvement of characterization assays.
Willing to travel if needed.
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Salary: 80-100k,
Job Type: Permanent,
Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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