Manufacturing Associate II, Upstream Processing

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 II, Upstream Processing works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role authors and revises manufacturing and process equipment documentation and is responsible for supporting necessary fermentation and production activities, including validation and development work as needed.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Job Description

Responsibilities:

Manufacturing & Compliance

• Performs daily fermentation steps of cGMP manufacture of CCH BDS.
• Works in a hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment as required.
• Ensures work is completed in compliance with approved SOPs, batch records, and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
• Assists with process, equipment, and cleaning validation initiatives.
• Assists in leading manufacturing activity as needed.

Documentation

• Authors and revises manufacturing and process equipment documentation.

Investigation

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

Qualifications:

Education & Experience

• High school diploma is required with a minimum of 2+ years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment, OR
• BS degree with 1+ years’ relevant experience noted above.
• Experience working with fermenters/bioreactors, holding tanks, aseptic operations, seed scale-up, CIP and SIP of process equipment is preferred.

Knowledge

• Working knowledge of cGMP practices, ICH guidelines, and validation practices.
• Working knowledge of fermenters, holding tanks, aseptic operations, seed scale-up, and cleaning and sterilization procedures for biopharmaceutical products.

Skills & Abilities

• Demonstrated ability to troubleshoot and resolve equipment and processing issues.
• Works well with others and establishes 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

• Ability to work in a clean room environment.
• Ability to stand 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.