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.
We have an opportunity for a Technology Manager / Senior Manager to join the Manufacturing Science and Technology (MSAT) team at AGC Biologics. This team member will lead the effort of technology management with cross-functional support across multiple suites, supporting product at all points in their lifecycle. This is a key leadership position in the MSAT team that is responsible for technology implementation and optimization throughput the product life cycle for our product portfolio. The MSAT team is responsible for the transfer, validation, manufacturing support, and implementation of new processes, technologies and systems used in GMP operations.
PRINCIPAL RESPONSIBILITIES INCLUDE:
Lead a cross functional team of Manufacturing, Supply Chain, MSAT, and Engineering to evaluate the single use materials in mammalian and microbial production suites. The evaluation should review single use materials for cost, fitness for use, and impact to product SISQP.
Review/author guidelines for implementation of single use systems in existing and future facilities based on the evaluation above.
Advise on deviations related to material defects and CAPA for material improvements.
Act as resource for the Tech Transfer team in identifying single use materials for inclusion in preliminary through finalized BOMs.
Support new tech transfers by driving new MSP requests.
As subject matter expert (SME), support the assessment of supplier change notifications.
Improve alignment of single use materials activities across the US sites, together with MSAT leaders at our other sites.
Interface with the project teams to support product life cycle change management projects, including drive long-term process improvements execution.
Evaluate novel solutions to existing single use challenges, such as designing a common SUM bag for multiple SUM systems.
Lead MSAT team in supporting manufacturing when troubleshooting processes on the manufacturing floor and during post-operational investigations
Lead and execute harmonization projects to align technologies and materials across multiple Manufacturing suites.
Review URS documents and participate in equipment design sessions. Ensure new equipment design meets operational requirements such as sampling, sanitization, and process performance.
Lead a cross-functional evaluation and drive implementation of technology alternatives where both single use and re-useable equipment are available.
KNOWLEDGE, SKILLS AND ABILITIES:
Experience mentoring and developing high performing teams.
Must be self-motivated, organized and proactive.
Ability to work on complex issues where analysis of situations or data requires in depth knowledge of the company objective.
Demonstrated ability to interface/communicate extensively with internal and external clients, including senior management on matters concerning several functional areas, divisions, and/or customers.
Ability to coordinate multi-departmental tasks and deliverables (interaction with Business Development, Process Development, Manufacturing, Engineering, Quality, etc.).
Demonstrated ability to build effective working relationships across departments (QA, Process Development, Project Management and Business Development) to support new processes and products.
Demonstrated experience leading troubleshooting efforts.
Strong communication skills necessary to interact with internal and external stakeholders, with an ability to obtain buy-in from all key stakeholders.
Strong presentation skills.
Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks.
EDUCATION / EXPERIENCE:
Bachelor’s Degree in Engineering or Science-related field with 8+ years of industry experience, or
Master’s degree with 6+ years of industry experience. Equivalent education and experience may substitute for stated requirements.
Minimum of 2 years primary biotechnology cell culture and/or recovery and purification experience, preferably in clinical/commercial GMP manufacturing.
Minimum of 2 years of experience bringing biotechnology equipment and processes from design through GMP operational readiness.
Must have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
Must have experience writing, reviewing and approving GMP documentation.
Hiring will commensurate with experience.
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.