Manufacturing Associate II-III (Fill/Finish)

About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.

SUMMARY:

In this role, the Manufacturing Associate II or III will be responsible for performing GMP Bioprocess operations associated with filtration, filling, inspection and labeling of drug products. The candidate will possess the necessary skills and expertise to perform operations safely, reliably and in compliance with stated processes and standards. We offer a dynamic environment, innovation, operational excellence, and career growth.

PRINCIPLE RESPONSIBILITIES:

• Assist in the production of clinical and commercial products under cGMP conditions through the use of Standard Operation Procedures (SOPs) and Master Production Records (MPR's).
• Performance of Fill and Finish processing operations (aseptic processing, sterile filtration, manual and automated filling, inspection and labeling).
• Completion of documentation required per process transfer protocols, validation protocols, change controls, standard operating procedures, and production records.
• Support Manufacturing process operations which may include the authoring/revising of SOPs, Batch Records and Reports.
• Collaborate with Quality Assurance, Shift Supervisors and other department representatives on quality events and investigations.
• Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.

• Perform review of completed GMP documentation.
• Create and maintain training materials and curricula.

• Provide training to team members on the set-up and use of equipment, process and material flows.
• Ensure clean rooms and support areas are maintained in an organized and ready state.

• Assist and collaborate with support groups on troubleshooting Fill and Finish operations.
• Other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

• Expertise in relevant math, science and engineering disciplines.
• Excellent aseptic technique with BSC operations and sampling.
• Thorough knowledge of GMP regulations as it applies to job function.
• Thorough understanding of single use equipment and technology as applies to job function.
• Ability to exercise independent judgement when applying industry practices and company policies to daily operations.
• Working knowledge of business practices used by company.
• Demonstrated ability to manage time efficiently and effectively.
• Ability to interact constructively with peers and support groups.
• Organizational and communication skills necessary to ensure daily work plan is executed.
• Must be detail oriented, with the ability to complete written and verbally assigned tasks following specific procedures.
• Ability to move/lift up to 40 pounds.
• Excellent technical writing skills.
• Due to the nature of manufacturing, shifts can and will vary. Shift preference may not always be available upon request.
• Ensure compliance with company quality systems, safety procedures, and other company policies.

EDUCATION/EXPERIENCE:

• BS in Chemistry, Biology or other relevant discipline.
• Depending on level, 2-8 years of relevant experience, including experience in aseptic processing and automated filling operations. Compensation is commensurate with experience.
• Advanced computer skills including Excel and Word.
• Equivalent education and experience may substitute for stated requirements.

COMPENSATION RANGE:

$28.73 - $49.55

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.