Process Engineer III (Relocation Assistance)

Summary:

The Process Engineer III is experienced with biological manufacturing platforms for impacting global health initiatives. The individual will have the desire to grow in both personal and professional areas of competence. The Process Engineer III is responsible for the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing. This position will work cross-functionally to define the manufacturing processes for current Good Manufacturing Practice (cGMP) production.

Responsibilities and Duties:

• May serve as project lead and/or principal investigator of projects to establish cGMP operations in clinical and commercial manufacturing.
• Leads the establishment of drug product fill finish and media/buffer manufacturing operations.
• Supports the introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of biological drug substances and products.
• Coordinates the information transfer and gap assessment of new processes and method transfers.
• Drafts technology transfer protocols and facility fit reports for the on-boarding and transfer of manufacturing operations in cGMP manufacturing suites.
• Uses change controls and corrective and preventative actions (CAPAs) to document cGMP changes and new controls
• Supports the documentation of events and deviations during cGMP manufacturing production.
• Ensures compliance with the quality document management system for process changes.
• Prepares unit operation bill of materials (BOMs) and drafting of BOMs for production planning and manufacturing.
• Supports the material forecasting of process materials and equipment.
• May support other tasks as determined by management.
• Adheres to Ology Bio’s Standard of Behavior Agreement and Expectations.

Basic Qualifications

• Bachelor of Science in engineering typically in chemical engineering, material science and engineering, industrial engineering, or mechanical engineering. A Ph.D. in chemistry, molecular biology, pharmaceutical sciences or other applicable science may be considered;
• Requires 4 years of experience in pharmaceutical or biologics industry in process development and manufacturing operations;
• Demonstrated process understanding of at least two manufacturing platforms supporting drug substance production and purification using adherent or suspension cell culture; or successful experience in the implementation of two drug product manufacturing process;
• Strong leadership, relationship management, and organizational planning;
• Ability and willingness to learn and adapt skillsets for various areas of MS&T;
• Ability to perform well under aggressive timelines with maintenance of high-quality output while under pressure;
• Knowledge of cGMP compliance around bioprocess drug substance or drug product manufacturing.

Preferred Qualifications

• Bachelor of Science in chemical engineering;
• Education in molecular biology;
• Experience with drug product manufacturing process development and CGMP manufacturing (4-years)
• Technical expertise aseptic processing.
• Prior cGMP experience (2-years minimum);
• Knowledge of regulatory compliance in pharmaceutical development.

Preferred Qualifications

This job requires the employee to perform the following physical activities:

• Climbing
• Balancing
• Fingering
• Stooping
• Kneeling
• Repetitive motion
• Crouching
• Reaching
• Standing
• Grasping
• Walking
• Pushing
• Hearing
• Pulling
• Lifting
• Talking

This job requires the employee to work in the following conditions:

• Temperature changes
• Activities occur inside and outside
• Outside environment conditions

This job requires exposure to the following:

• Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
• Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.

This job requires the employee to perform the following type of physical work:

• Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects

This job requires routine or periodic use of respiratory protection:

• Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).
• Tight-fitting respirators, such as half-masks or full facepieces which must seal to the face or neck.