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.
Purification Manufacturing Supervisor - Microbial works collaboratively in executing purification bioprocess operations which includes column packing, chromatography TFF, Filling and CIP/SIP operations (cleaning, assembly, sterilization, disassembly, operation of primary process equipment). The ideal candidate possesses strong computer and multi-tasking skills, strong verbal and written communication skills, and experience working in a fast-paced, dynamic environment with limited supervision.
- Ensure staff compliance with all company / regulatory quality systems, safety procedures, and SOPs
- Review and ensure errors during manufacturing operations are corrected
- Provide leadership by establishing priorities, clear expectations, and demonstrating high standards of work practices
- Train, coach and mentor manufacturing technicians / associates on manufacturing functions.
- Complete required documentation including but not limited to deviation reports, change control, product change over and maintenance task
- Review/approval executed manufacturing MBRs.
- Responsible for daily organization of work flow and delegating responsibilities for shift operations as needed
- Perform and monitor staff during unit operations as described in standard operating procedures and batch records
- Develop staff (i.e. goal setting, assignment of development activities, performance reviews, etc.)
- Promote a safe work environment.
- Unit operations described in standard operating procedures and batch records (50%-100% of effort)
- Perform manufacturing operations, column packing, chromatography, solution preparation, tangential flow filtration and filling.
- Recommend and execute projects and changes to bioprocess operations to reduce risk and increase efficiency
- Complete required processing documentation including deviation reports, change control, product changeover, etc.
- Identify, create and revise GMP documentation as required including MBRs
- Review GMP documentation and participates in training and development opportunities to gain understanding of compliance requirements and departmental policies.
- Participate in validation activities including IQ/OQ/PQ and process validation
- Assist in compliance and technical development projects
- Perform document revisions to Standard Operating Procedures
- Initial training and application of GMP regulations (ICH Q7A) as it applies to job function
- Other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES:
- Working knowledge in relevant math, science, and engineering disciplines
- Ability to communicate, read, and write legibly in English, as well as possession of strong technical writing skills
- Ability to apply advanced computer skills including work with spreadsheets(Excel) and word processing (Word)
- Functional understand and experience operating the AKTA chromatography system and unicorn software.
- Ability to manage time effectively
- Must be detail oriented with the ability to complete written and verbally assigned tasks following specific procedures
- Demonstrated ability to apply excellent aseptic technique
- Working knowledge of GMP regulations (ICH Q7A), as well as experience with equipment and technology as it applies to job function
- Ability to interact constructively with peers and support groups, using organizational and communication skills necessary to plan and execute work flow
- Bachelor’s Degree and 5+ years of relevant work experience, including prior experience in aseptic processing.
- Proven experience working in manufacturing operations
- Proven experience and knowledge in bioprocess operations such as solution compounding or tangential flow filtration
- 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.