Scientist, Manufacturing Science and Technology, Cell Culture (Hopewell, NJ)

Role Summary

Scientist, Manufacturing Science and Technology, Cell Culture (Hopewell, NJ). This role supports analysis, design and execution of cell culture development activities, tech transfer, process improvements, and collaboration with cross-functional teams in a manufacturing science environment focused on drug substance manufacturing.

Responsibilities

• Participate in cross-functional project teams that provide tech support to manufacturing and process development, and present data and study findings coherently.
• Ensure a safe working environment.
• Execute laboratory experiments and maintain supporting 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.
• Communicate effectively with team members and stakeholders.
• Serve as Person-In-Plant (PIP) during critical steps of the manufacturing process when required.
• Perform manufacturing data analysis as required.
• Other assignments as determined by the manager.

Qualifications

• Required: BA/BS in science, biochemistry, biotechnology, biology, chemical engineering or related discipline with 2+ years of Life Science/Biotechnology experience.
• Required: Knowledge of Mab Facilities and Process Design / Development.
• Required: Knowledge of biopharmaceutical equipment qualification and validation activities.
• Required: Cell culture knowledge including inoculum processes, bioreactor systems, harvest processes and analytical equipment.
• Required: Ability to analyze data, detect inconsistencies, determine relative importance, conduct root cause analysis, and risk management.
• Required: Experience with tech transfer to clinical/commercial manufacturing facilities.
• Required: Knowledge of study design such as DOE and authoring of study protocols/reports.
• Required: Good understanding of GMP requirements.
• Required: Proven planning and data analysis skills; experience with statistical software to analyze data.
• Required: Project management skills related to internal and external teams.
• Required: Knowledge of FDA, EMA, ICH, PDA regulations and guidelines.
• Required: Demonstrated experience working in a cell culture laboratory or equivalent.
• Required: Knowledge of drug preclinical, clinical and commercial requirements.
• Required: Familiarity with EMA and FDA regulatory requirements for submissions.
• Required: Effective communication, both oral and written, in a multi-disciplinary, project-driven environment.
• Required: Experience with software such as Microsoft Office, JMP or SAP.

Skills

• Strong communication and data presentation skills.
• Analytical thinking and problem-solving aptitude.
• Proficiency with Microsoft Office; JMP or SAP experience is preferred.

Education

• BA/BS in science, biochemistry, biotechnology, biology, chemical engineering or related discipline (as described in Qualifications).

Additional 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 working in varying temperatures and gowning in manufacturing areas when required.
• Repetitive motion and substantial movement of wrists, hands, and/or fingers; exposure to 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%.