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. 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.
The Manufacturing Specialist performs GMP manufacturing operations safely, reliably and in compliance with stated processes; develops new technologies/equipment, and implements new systems, process improvements, equipment and procedures.
- Support the implementation of new processes in close collaboration with our Process Transfer and Process Development teams.
- 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
- Follow-up on production campaigns including client communication, review and approval of batch records, troubleshooting, handling of deviations and CAPAs
- Participate in customer meetings providing manufacturing updates.
- Develop and update required documentation including:
- Quality documents, such as Standard Operating Procedures (SOPS) and other technical procedure documents
- User Requirement Specifications
- Manufacturing Impact Assessments
- System deployment checklists
- Commissioning workbook
- BMRAM asset registration forms
- GMP asset review forms
- Deviation, change control and product change over reports
- Review GMP documentation
- Sign executed process and solution MBRs
- Recognize and correct errors in bioprocess operations prior to failure.
- Recommend and execute projects and changes to bioprocess operations to reduce risk and increase efficiency.
- Assist with on-boarding and validating of new equipment and processes
- Work with clients on process mapping and scale-up of manufacturing processes
- Other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
- Expertise in relevant math, science and engineering disciplines.
- Expertise in AKTA Unicorn Software, up to and including, writing fully automated Unicorn methods for both Isocratic and Gradient elutions
- Expertise in automated and manual column packing; including BPG, Quikscale, Chromaflow and Axichrom columns
- Expertise assembling, disassembling, operating and understanding complex equipment and processes, including UF/DF operations, Viresolv and Planova Nanofiltration
- Demonstrated knowledge of aseptic technique
- Thorough knowledge of GMP regulations (ICH Q7A) as it applies to job function
- Thorough understanding of equipment and technology as applies to job function.
- Demonstrated ability to work independently and multitask under aggressive timelines 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 documentation
- Must be detail oriented, with the ability to complete written and verbally assigned tasks following specific procedures.
- Ability to interact constructively with and influence peers and support groups
- Ability to exercise independent judgement when applying industry practices and company policies to daily operations.
- Ability to exercise independent judgment required to apply business systems to functional area.
- Ability to lift up to 50 pounds
- Ability to wear and work in clean room garments
- BS in BioChemistry, Chemistry, Biology or other relevant discipline required; MS in related discipline preferred
- 5+ years’ relevant experience in a CDMO performing the following:
- Bioprocessing manufacturing, preferably in large-scale operations
- Installing and qualifying production equipment
- Utilizing AKTA Bioprocess chromatography systems and conducting large scale column packing.
- Executing unit operations described in standard operating procedures and batch records
- Performing bioprocess operations such as filtration, purification, cell culture or recovery
- Cleaning, assembling/disassembling, sterilizing and operating primary process equipment
- Completing required processing documentation including deviation reports, change control, product change over, etc
- Reviewing/signing executed process and solution MBRs
- Mentoring floor supervisor to organize work flow on their shift;
- Leading team of operators in day-to-day activities.
- Training manufacturing technicians on theories and concepts of the bioprocess operations.
- Ensuring compliance with company quality systems, safety procedures, and other company policies.
- Ensuring acceptable quality and quantity of work executed.
- Ensuring that standard operating procedures are followed and are correct for bioprocess operations and equipment
- Aseptic processing
- Advanced computer skills including Excel and Word.
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