Employment Type: Permanent Position

Job Category: Biomanufacturing

Department: Manufacturing

Reports To (Position): Manufacturing Manager

Job Number: 2582121

Position Overview:

This role will represent the Manufacturing function for quality workflow and quality-based documentation via a Quality Management System (QMS) and Document Management System (DMS) including items like deviations, investigations, change controls, corrective actions and preventative actions, and effectiveness checks. As needed, this role also may support manufacturing operations.

Accountabilities and Responsibilities:

• This role will work within the Manufacturing Department reporting to the Manufacturing Manager.
• Represent manufacturing in managing quality events, change controls, continuous improvements and other quality workflows.
• Investigate manufacturing process and facility related deviations for a cGMP biologics manufacturer.
• Collaborate with Technical Operations departments to identify process improvements in the way of CAPAs.
• Participate in audits as needed.
• Write, review, and approve Standard Operating Procedures, Batch Records, Work Instructions, and other quality documentation.
• Supports Manufacturing cGMP production as needed.

Essential Details:

Work Schedule

Full-time; day shift. Occasional support for off-shift hours as needed (early mornings, late evenings/nights, and weekends).

Travel

Less than 10%

Safety

This role should be able to lift 35lbs. This role may work around high energy systems, hazardous chemicals and solutions including corrosives and viral materials.

Quality Responsibility

Support the manufacturing function cGMP compliance by identifying process improvements for safety, quality, and efficiency of process execution.

Scope

Works on issues of diverse scope where analysis of situation or data requires a review and evaluation of identifiable factors. Exercises judgement within defined procedures and regulations, selects appropriate methods and techniques in obtaining solutions in determining appropriate actions or resolutions.

Minimum Requirements:

Education

Bachelor’s degree in biology or related field

Experience / Minimum Requirement

• 2+ years in investigation experience in a pharmaceutical/biotech industry setting.
• Experience owning change controls preferred.
• Working in or alongside a cGMP process for 2+ years is required.
• Experience working with Gene Therapies preferred.
• High attention to detail.
• Track record of successfully leading collaborations to an end goal.
• Ability to work within a cleanroom environment as needed.

Licenses or Certifications

• Biotechnology/manufacturing certificate a plus
• Lean Six Sigma certifications a plus

Knowledge, Skills and Attributes

• Ability to track and measure performance against defined metrics, such as on-time delivery of quality workflow closure.
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.
• High attention to detail.
• Knowledge and ability to interpret and understand regulations related to the manufacturing of biologics.
• Work in a Quality Management System.
• Use Root Cause Analysis tools to identify and select a root cause

Work Environment

• A majority of the work is done in a private office, warehouse or manufacturing environment. The manufacturing environment is a cleanroom where appropriate gowning is required to be worn. Work may involve high energy hazards, such as steam, high pressure gases, flammable materials, high temperature liquids and high voltages, cryogenic operations, loud machinery and chemical hazards such as strong acids and bases.

Relocation Assistance: Yes