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.
The role of the Manufacturing Technical Manager is to act as a controller, providing essential duties to support the respective production suite, Supervisor and Manager. This position allows both the Supervisor(s) and the Manager to be present on the floor; to oversee critical operations, coach and develop their teams, and ensure systems and activities are set up and working to deliver expected results under minimal direction. On a daily basis, the Manufacturing Technical Manager is expected to have a full understanding of the schedule and the process; promoting adequate assessment and response of any production needs. The Manufacturing Technical Manager will be responsible for fulfillment of immediate requests from the Mfg. support departments including, but not limited to, approval for WO commencement for calibration and facilities/suite maintenance, QA tag out placement and removal, and response to customer or MSAT process related inquiries. Outside of daily requests, the Manufacturing Technical Manager will own the suite specific planning schedule and Mfg. activities including, Engineering/validation testing, PM’s, changeover, and column packs and unpacks, as applicable. The Purification Manufacturing Technical Manager will also be responsible for resin, mesh and membrane management.
To further support the daily operation of the suite, the Manufacturing Technical Manager will assist the Supervisor and Manager with immediate triage response; aide in trouble shooting, attend cross-functional meetings to determine and plan for a path forward, own immediate follow-up actions, communicate path forward to all shifts and provide necessary input into the deviation investigation.
Provide on the floor support for respective area, Manager
- Work cross-functionally with Scheduling to identify and plan for any non-routine suite and equipment windows needed
- Engineering work, validation, etc.
- Coordinate and approve Mfg. support department requests for work in suite
- Calibration, facilities/suite maintenance, elastomer team, etc.
- Provide response to MSAT/Customer process related inquiries
- Resin, mesh and membrane management
- Cycle counts, scrap form completion, disposal
- Coordinate placement and removal of quality tag-outs.
Own suite specific planning schedule
- Plan changeover, packing/unpacking activities (as applicable for area)
- Coordinate PM work across shifts
- Collaborate with area leaders to ensure the resources are available to support above deliverables at requested times
Support immediate triage response
- Aide in troubleshooting
- Attend cross-functional meetings to provide input into path forward
- Own immediate Mfg. follow-up actions (ie. batch record redlines)
- Provide detailed communication to suite and provide input into deviation investigation.
- Supported by the manager, own and drive major investigations (contaminations, CPP failures, etc)
- Perform risk assessments and/or justifications for forward processing, when applicable
Administrative tasks –attending shift exchange and daily production meetings, sending/receiving emails, training, etc.
KNOWLEDGE, SKILLS & ABILITIES:
- Strong technical knowledge and understanding of suite, equipment and process flow- capabilities and limitations
- Equipment overlaps, sterile boundaries, controls conflicts, etc.
- In-depth understanding of GMP and quality/compliance policies and procedures
- GMP documentation, Quality tag-outs, deviations, appropriate decision making channels, etc.
- Solid understanding of scheduling tools and platforms
- Must be able to communicate clearly, both verbal and written, in English
- Demonstrated expertise using Microsoft Excel, Word, and Power Point
- Technical writing
- Strong organization skills with the ability to prioritize tasks for staff
- Ability to work hours necessary to support production and / or maintenance activities.
- Ability to lift up to 40 lbs. with assistance.
- Possess solid critical thinking and problem solving skills
- Able to use experience and knowledge to propose solutions (conventional and non-conventional)
- Strong decision making skills
- Able to assess options, pros/cons, risks to product/safety/quality/business and aide in prompt decision making under dynamic conditions
- Effective communicator, verbal and written
- Flexible, able to respond to daily changing demands
- Solid interpersonal and teamwork skills, able to work cross-functionally and collaborate with various levels.
- Strong planning and organizational skills
- Able to manage a fluid daily schedule
- Able to have a holistic view of suite planning, at least a month out, and recognize potential impact and needs as a result of changing demands
AS/BS in Biotechnology, Biology, Chemistry, or equivalent
- High School Diploma or Equivalent may be considered with relevant experience
Individual must have experience working in a GMP or similar setting, familiarity with Manufacturing environments, large scale equipment and process flow (respective production area preferred) and previous exposure to planning/scheduling tools
- Minimum 10 years industry 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