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**General Description** :

This position is a critical role within the MST Cell Culture laboratories and activities may include but are not limited to Media Preparation, Inoculum, Seed/Production Cultivation and Harvest process, therefore previous experience is preferred. The position will be responsible for design and execution of laboratory experiments, data analysis and authoring of various reports. This position reports directly into the Associate Director, Manufacturing Science and Technology (MST) Cell Culture and is located at the Hopewell, NJ site.

The position will support process improvements, troubleshooting, compliance related activities and provide technical support to Drug Substance manufacturing. Process monitoring and trend analysis of manufacturing operations will also be another key activity that will be required for the position.

The position will be very involved with tech transfer activities through the lifecycle of a project which include gap and risk assessments, generating technical transfer plans, process descriptions and control strategies, related protocols and reports, and continuous process verification.

Working in Cell Culture MST provides a unique growth opportunity for professional exposure to many facets of process development and drug substance manufacturing. This position involves close collaboration with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, Process Development groups and MST counter parts located in other sites and countries.  In addition, as BeOne Hopewell continues to progress, many unique opportunities and challenges will occur for anyone who is looking for career advancement.

**Essential Job Functions** :

+ Participate in cross-functional projects teams that provide tech support to manufacturing and process development, and able to present data and study findings in coherent manner.

+ Ensure a safe working environment.

+ Responsible for execution of laboratory experiments and maintaining support laboratory activities.

+ Author study protocols and reports, and other documentation supporting deviations and regulatory activities.

+ Perform tech transfer activities, including facility gap and risk assessments.

+ Provide technical support as SME for implementation of cell culture processes.

+ Author technical transfer plans, process descriptions, control strategies, and campaign summary reports.

+ Author Process validation plan, PPQ protocols, and various upstream study protocols to support PPQ.

+ Perform Continued Process Verification (CPV) and process monitoring during campaigns.

+ Effective communication with team members and stakeholders is a must.

+ Serve as Person-In-Plant (PIP) during critical steps of the manufacturing process, when required.

+ Perform manufacturing data analysis as required.

+ Any other assignments as are determined by the manager.

Education/Experience Required:

+ BA/BS in science, biochemistry, biotechnology, biology, chemical engineering and/or related discipline with 2+ years of Life Science/Biotechnology experience required

+ Knowledge of Mab Facilities and Process Design / Development.

+ Knowledge of biopharmaceutical equipment qualification and Validation activities.

+ Cell culture knowledge including inoculum processes, bioreactor systems, harvest processes and analytical equipment.

+ Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, and utilizing data, conducting root cause analysis, and risk management.

+ Experience with tech transfer to clinical/commercial manufacturing facilities.

+ Knowledge of study design such as DOE and authoring of study protocols / reports.

+ Good understanding of GMP requirements.

+ Proven planning and data analysis skills, use of statistical software to analyze data

+ Project management skills related to internal and external teams

+ Knowledge of regulations and guidelines of FDA, EMA, ICH, PDA.

+ Demonstrated experience working in cell culture laboratory or equivalent.

+ Knowledge of drug preclinical, clinical and commercial requirements.

+ Familiarity with EMA and FDA regulatory requirements for submissions.

+ Effective communication, oral and written, in a multi-disciplinary, project-driven work environment.

+ Experience with software such as Microsoft Office, JMP or SAP.

Computer Skills:

+ Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

+ JMP or equivalent

+ SAP or equivalent

**Physical Requirements** :

+ Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.

+ Must be able to work scheduled 40 hours with the ability to work overtime as needed.

+ Must be comfortable in working in varying temperatures.

+ Ability to gown and work in manufacturing areas, when required.

+ Some reaching, bending, stooping, and twisting

+ Repetitive motion and substantial movement of the wrists, hands, and/or fingers.

+ Environment requires dedicated gowns, depending on area.

+ Work with potentially hazardous materials and chemicals.

+ Willing to work off shift, when required.

**Travel:** Some travel may occur as a result of duties assigned to the role, up to 20%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.