Manufacturing Project Specialist I-Sr

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.

JOB SUMMARY

The Manufacturing Project Specialist I-Sr will be responsible for identifying and executing projects that directly relate to process readiness, right first-time execution on the manufacturing floor and facility. This role works in close collaboration with site cross functional groups including but not limited to QA, MSAT, Validation, and Facilities/Engineering.

PRINCIPAL JOB DUTIES & RESPONSIBILITIES

• Support the implementation of corrective actions, change controls, and general process improvements in close collaboration with Program Managers, Process Transfer, Engineering, QA, and Validation teams.
• Provide support to manufacturing staff for new equipment and processes.
• Ensure process optimization and continuous improvement.
• Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.
• Collaborate with engineering and validation teams to implement and qualify new equipment and controls.
• Author, update, review and approve quality documents, such as Standard Operating Procedures (SOPs) and other technical procedures.
• Follow-up on production campaigns including client communication, review and approval of executed batch records, troubleshooting, handling of Change Records and CAPAs.
• Participate in customer meetings providing manufacturing updates.
• Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression.
• Work closely with manufacturing operations and QA team to drive CAPAs to timely closure.
• Serve as liaison between multiple groups including Manufacturing, Quality, and Process Transfer.

KNOWLEDGE, SKILLS, & ABILITIES

• Ability to interact constructively and influence peers and support groups.
• Prior experience with technical writing and in a manufacturing environment preferred.
• Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time delivery. Must work well on a team and be able to troubleshoot and problem solve in a cross functional team setting. Must be proactive, action oriented, and adaptable to change. Must be able to identify and flag risks in a timely manner to keep deliverables on track.
• Strong written and verbal communication skills are required. Ability to read and comprehend complex subjects. Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
• Ability to understand and apply GMP regulations as they relate to manufacturing.

TECHNICAL SKILLS

MFG Project Specialist I:

• An understanding of biopharmaceutical manufacturing process (microbial or cell culture), related equipment and purpose and function of supporting processes.
• An understanding in the application of cGMP requirements.
• Manage and own CAPAs, SOPs, and WOI revisions.
• Be point of contact for technical writing team (questions, clarifications, etc).
• Work closely with Manufacturing operations and QA team to drive CAPAs to timely closure.
• Represent the interests of the Manufacturing team in collaborative and interdepartmental projects, including but not limited to equipment onboarding, process development and onboarding tasks, manufacturing support and training.
• Follow up on production campaigns, including review and approval of documents, troubleshooting, CRs and CAPAs.
• Participate in client meetings providing manufacturing updates.

MFG Training Specialist II

• All Manufacturing Project Specialist 1 tasks.
• Own and manage change records.
• Maintain primary point of contact status for client facing manufacturing for assigned upstream or downstream function.
• Act as upstream/downstream core team representative with some managerial support.
• Support deviation investigations as needed.

MFG Training Specialist III

• All Manufacturing Project Specialist 1 and 2 tasks.
• Act as upstream/downstream Core Team representative with minimal managerial support.
• Engages in both upstream / downstream manufacturing areas, occasionally.
• Large project owner and SME.
• Lead technical support for GMP manufacturing, focusing on investigations and root cause analysis.
• Participates in Quality Risk Management programs.
• Supports regulatory inspections as SME.
• Support to batch disposition actions, as required.

MFG Training Specialist Senior

• All Manufacturing Project Specialist 1, 2, and 3 tasks.
• Act as interim supervisor on an as needed basis.
• Seamlessly supports both upstream / downstream manufacturing areas, as needed.
• Leads Quality Risk Management programs.
• Mentors peers.

EDUCATION & EXPERIENCE

• BA/BS degree in a science related discipline preferred or combination of education and work experience.
• Level I: 2+ years of experience in bioprocessing manufacturing, preferably in large-scale operations.
• Level II: 4+ years of experience in bioprocessing manufacturing, preferably in large-scale operations.
• Level III: 6+ years of experience in bioprocessing manufacturing, preferably in large-scale operations.
• Level Sr: 8+ years of experience in bioprocessing manufacturing, preferably in large-scale operations.
• Expertise in GMP and bioprocessing knowledge.

Levels I - III: $32.19 - $55.48 (per hour)

Senior Level: $94,000-$129,250 (Salary)

This is an official AGC Biologics Human Resources Document and is intended for internal distribution to company employees only. Any external use or distribution of this document is prohibited without the express approval of the Human Resources Department. This job description has been designed to indicate the general nature and level of work performed by employees in this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

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. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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.