Manufacturing Project Specialist II
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
SUMMARY:
The Manufacturing Project Specialist II performs GMP tasks reliably and in compliance with stated procedures; implements new systems, process improvements, equipment and procedures.
PRINCIPAL RESPONSIBILTIES:
- Support the implementation of processes in close collaboration with our Process Transfer and Process Development teams
- Ensure process optimization and continuous improvement
- Communicate cross-functionally across departments, share project-related risks and issues, manage schedules, timelines and expectations
- Follow-up on production campaigns including client communication, batch record reviews, troubleshooting, handling of deviations and Corrective and Preventative Actions (CAPAs)
- Assist in the development and management of project strategic plans and program initiatives to meet the goals and needs of manufacturing
- Draft, review, and/or approve GMP documentation
- Recognize and correct errors in bioprocess operations prior to failure in collaboration with manufacturing
- Recommend and execute projects and changes to bioprocess operations to reduce risk and increase efficiency
- Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed
- Assist with on-boarding and implementation of new equipment and processes
- Opportunity to assist with internal audits and regulatory inspections
- Other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES:
- Experience in relevant math, science, and engineering disciplines.
- Demonstrated knowledge of aseptic processing and technique
- Thorough knowledge of cGMP regulations and compliance
- Thorough understanding of equipment and technology as it applies to job function
- Strong interpersonal skills and the ability to influence without authority
- Demonstrated ability to work independently and manage multiple projects to support department and company objectives
- Working knowledge of business practices used by company
- Demonstrated ability to manage time efficiently and effectively
- Organizational and communication skills necessary to ensure daily work plan is executed
- Excellent technical writing skills to create GMP documentation
- Must be detail oriented, with the ability to complete written and verbally assigned tasks following specific procedures
- Demonstrate technical knowledge and strong problem-solving skills
- Ability to exercise independent judgement when applying industry practices and company policies to daily operations
- Ability to don required garments and work in cleanroom environments
- Proficient in Microsoft Teams, Excel, PowerPoint, Outlook and Word
EDUCATION/EXPERIENCE:
- BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline required
- 5-7 years' experience working in a regulated or GMP environment required
- Experience managing and delivering projects required
- Experience with quality management systems (MasterControl, Trackwise, etc.) preferred
- Experience with asset management software (Blue Mountain, Maximo, etc.) preferred
- Equivalent education and experience may substitute for stated requirements
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.