Support the daily operations of the Biopharmaceutical Development Department by performing assigned large molecule-based method development, validation and characterization studies in accordance with cGMP requirements, company policies and procedures as directed by laboratory management.
Perform complex method feasibility, development, verification, transfer, qualification, validation and/or characterization testing of biopharmaceutical raw materials, intermediates, API, and/or drug product samples in accordance with cGMP requirements.
Work on routine tasks where analysis of situations or data requires review and evaluation of limited factors, limited judgment is required in resolving problems and making routine recommendations. Exercise judgment within defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
Assist technical project lead in communicating effectively with internal and external stakeholders during project related discussions or in written communications, including, but not limited to, schedule updates, presentation of technical data, interpretation of results, and/or collaborations on quality exceptions. Work closely with the team to resolve technical issues.
Prepare quality technical documentation, such as protocols, test methods, investigation summaries and other technical reports working closely with relevant laboratory and/or Quality Assurance management.
Notify Supervisor of any discrepancy in laboratory testing or general laboratory operations. In case of any observed discrepancies, initiate and follow through with the required quality exception documentation as needed.
Assume ownership of assigned quality documentation, such as exceptions, change controls, and CAPAs, ensuring that documentation is initiated and closed on time, required actions are thorough and meet procedural requirements as well as customer needs.
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.
**Qualifications – Experience and Education:
Bachelor's degree in Biochemistry or equivalent in scientific discipline required. Advanced degree preferred. A minimum of 6+ years cGMP pharma work experience required.
Knowledge, Skills, and Abilities:
Advanced knowledge of biomolecule testing principles and techniques using various laboratory apparatus and instrumentation (i.e. High-Performance Liquid Chromatography (HPLC) Ultra-Performance Liquid Chromatography (UPLC), Western blot, Gel Electrophoresis, PCR techniques, and general Protein and DNA/RNA analysis is required. Experience in Gene sequencing, Mass Spectrometry, and Capillary-based electrophoresis (CE and icIEF) is a plus.
Advanced knowledge of the ICH requirements for method verification, transfer, qualification, and validation.
Knowledge of root cause investigation and problem solving; experience in the use of 5 Whys and/or other appropriate root cause investigation tools.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, etc.).
Strong interpersonal and communication skills to work well independently and effectively with a wide variety of colleagues both inter- and intra- departmentally.
Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed.
Ability to act independently to determine methods and procedures for working on new assignments.
Ability to write test procedures, protocols, and reports according to applicable methodologies/regulations.
Ability to work effectively under pressure in a rapidly changing environment.
Ability to understand and apply complex technical concepts to laboratory operations developing solutions to complex problems that require an in-depth degree of ingenuity, creativity, and innovation.
Job Type: Full-time