Biological\/Chemical Scientist\/Engineer 2 - Newark, DE, 19702

Campus4Tech; Newark (NJ); On-site; USD 80,000 - 120,000; Full time

Job summary

Une entreprise innovante dans le secteur biopharmaceutique recherche un expert en gestion de projets pour superviser la production d'anticorps monoclonaux. Vous serez responsable de l'optimisation des processus, de la création de normes opérationnelles, et de la collaboration avec les équipes pour garantir la conformité et l'efficacité. Ce rôle requiert un diplôme avancé en sciences appliquées et de solides compétences en leadership et en communication.

Qualifications

• Expérience dans des techniques de laboratoire et manipulation sécurisée de produits chimiques.
• Familiarité avec la technologie des bioréacteurs à usage unique.
• Capacité à coacher et encadrer des membres juniors.

Responsibilities

• Gérer des projets de qualification et d'optimisation de la production d'anticorps monoclonaux.
• Travailler sur la conformité de la chaîne d'approvisionnement.
• Conduire des activités de troubleshooting et changer les processus selon les besoins.

Skills

Laboratory Techniques

Aseptic Techniques

Problem Solving

Leadership

Communication

Education

MS or Ph.D. in Mechanical Engineering

Industrial Engineering

Chemical Engineering

Biomedical Engineering

Electrical Engineering

Biochemistry

Biology

Chemistry

Job description

Description

Strong business acumen essential to properly manage shifting priorities in a fast-paced manufacturing environment. Job entails translation of business needs into prioritization of projects and workload to safeguard supply chain continuity. Leads productivity projects and collaborates with TechOps on technical troubleshooting, root cause investigation, and corrective action implementations.

Requires basic theoretical and practical understanding of antibodies and their application to Immunochemistry.

Functions And Responsibilities Include But Not Limited To

Reports to Manager responsible for Hybridoma and recombinant monoclonal antibodies manufacturing and qualification of antibodies, collaborating on all aspects of supply chain compliance.

Drives qualification and optimization of hybridoma and recombinant cell line to produce monoclonal antibodies using state of the art Single Use Bioreactor technology, shaker flasks, and roller bottles.

Creates required SOPs to clearly define (standard work), step-by-step, optimization of cell culture expression and qualification of monoclonal antibodies. This includes clear description of design of experiments (DOE), data interpretation and application.

Proactively Shares Information By Establishing Data Review At The Various Gates Of The Production And Qualification Of Cell Line To Produce Monoclonal Antibodies

Lead troubleshooting activities on commercial and new product. This includes but is not limited to batch record review, lot tracing, raw material evaluation, design, and execution of experiments.

Lead simple to complex process change projects, including demonstrating feasibility, developing validation protocol, executing proper qualifications, and driving necessary changes (equipment, process, test method, procedure, training, etc.)

Lead the product change using change management processes

Collaborating in cross functional and cross site teams

Coaching and mentoring junior members

Process improvements using HPS methodologies, SPS, VSM

Implementing change

Skills

Understand general laboratory techniques such as aseptic techniques, mixing, filtration, etc.

Familiar with Single Use Bioreactor technology and cell culture process optimization

Know how to safely handle chemicals and biochemicals.

Trained on good laboratory practices, good documentation practices.

Strong written and verbal communication

Leadership

Coaching

Interpersonal communication

Problem solving competency

Decision Making

Influence without authority

Negotiation

Integrity

Empathy

Requirements

Degree:

MS or Ph.D. Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, Electrical Engineering, Biochemistry, Biology, Chemistry, or related sciences