Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Manufacturing Associate I, Downstream Processing works in a hands-on capacity in the cGMP purification and production support areas to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role is responsible for supporting necessary purification and production activities, including validation and development work as needed.

Job Description

Responsibilities

Manufacturing & Compliance

Performs daily purification steps for cGMP manufacture of CCH BDS.Works in a hands-on capacity to operate chromatography systems, ÄKTA chromatography controllers, UF/DF skids, perform sterile filtrations, prepare production buffers, and clean equipment.Responsible for clean room readiness, stocking, and transfer of materials into the Manufacturing Facility.Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.Assists with process, equipment, and cleaning validation initiatives.

Documentation

Assists with GMP document revision.

Investigation

Assists in the resolution of manufacturing deviations/non-conformances.Under direct supervision, assists with troubleshooting processes and equipment.

Qualifications

Education & Experience

High school diploma is required with a minimum of 0-1 years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment ORBS degree

Knowledge

General knowledge of cGMP practices, ICH guideline, and validation practices.General knowledge of equipment cleaning practices and purification methods for biopharmaceutical products.

Skills & Abilities

Ability to work well with others and establish working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.Exhibits attention to detail, accuracy in work, and integrity of character.Self-starter, shows willingness to learn and problem-solve.Has technical aptitude to learn and operate production equipment.

Physical Requirements

Standing for long periods of time.Ability to wear a sterile gown and don shoe covers on a daily basis.Ability to lift 40 pounds.

EEO Statement:

We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.