BioProcess Specialist II

Description

Scope of Function: The Bioprocess Specialist II position reports to the Upstream Manufacturing Senior Manager. Prior experience in GMP manufacturing, operation of GMP process equipment, and aseptic technique are prerequisites. This role is responsible for supporting the overall Upstream GMP process through the application of broad knowledge of theories and principles utilized to solve operational as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II/III and commercial GMP manufacturing.

Specific Duties:

· Operates pharmaceutical manufacturing equipment such as incubators, wave reactors, single-use and stainless steel bioreactors, single use mixers, depth filtration skids, TFF skids, chromatography skids and in-process testing equipment.

· Executes all Upstream Clinical Manufacturing and Development operations, including but not limited to work functions in cell culture, cell banking, media optimization, seed train preparation, bioreactor operations, harvest/clarification, and technology transfer to manufacturing.

· Demonstrates, understands and adheres to Goodwin Biotechnology policies, GMP standards and safety procedures.

· Performs and monitors critical processes, execute manufacturing batch records (MBR) for specific projects to manufacture cell-derived biopharmaceuticals in compliance with cGMP guidelines and regulations.

· Informs supervisor/manager on progress of projects, transfer data, process details, etc.

· Supports the development of batch records, SOP’s and protocols as required.

· Supports Goodwin Biotechnology QA during audits and regulatory inspections.

· Supports other manufacturing processes teams and other GBI groups (when necessary) to achieve manufacturing goals.

· Executes any related ERP transactions to ensure that materials are requested on-time for the current and upcoming projects.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list all duties. Nothing in this job description restricts management’s right to assign and reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Education and Experience:

· BS degree in Science or Engineering or other related field and 0-1 years of experience with biologic production processes under GMP compliance. Upstream experience preferred.

· Excellent documentation skills including comprehension and review & establishing batch production records.

· Experience working in a federally regulated cGMP environment is a plus. The ability to work cross-functionally with multiple departments and excellent oral and written communication skills are required.

including 

Interacts

· Quality Assurance

· Supply Chain

· Quality Control

· Engineering & Facilities

· Validation

· Supply Chain

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Requirements

• BS Degree In Science or Engineering, or another related field with 3-4 years of experience with biologic production processes under GMP compliance. Upstream experience preferred. 
• Excellent documentation skills including comprehension and review & establishing batch production records
• Experience working in a federally regulated cGMP environment is a plus.
• ERP knowledge (NetSuite) preferred.

Salary : $65,800 - $83,300