About Nucleus Biologics:
At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations.
Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability.
About the role
- As the Manufacturing Manager at Nucleus Biologics™, you will assist the Operations & Manufacturing team and report into the VP of Operations. This individual will sit out of our 10908 Technology Pl location in San Diego.
- This role will be primarily responsible for Manufacturing Department personnel, process and progress.
- Ideal Candidate: GMP & ISO 13485 knowledge, aseptic closed system manufacturing, knowledge of chemistry of media/components use in biology and SDS creation of finished products.
RESPONSIBILITIES:
Manufacturing duties
•Oversee daily manufacturing operations and ensure compliance with company policies, quality standards, and regulatory requirements.·Document review and approval of Specs, Batch Record and Work Instructions·Quality Events Management; NCR investigations and CAPA reviews/sign-off, QERB·Troubleshoot and provide guidance on production issues or in-process questions·Amplify visibility of relevant metrics (Customer Commit, Quality, Safety, etc.)·Ensure compliance with regulatory requirements including OSHA, GMP and EH&S·Maintain a culture of responsibility and performance·Operate consistently within ISO 13485, EXCiPACT, and cGMPguidelines•Adhere to production schedule to meet specified volumerequirements•Ensure a safe and clean work environment in accordance with company and industry standards.•Assist with production schedules to meet internal and customer demand.•Continuously evaluate and analyze manufacturing processes to identify areas of improvement and implement effective solutions.•Collaborate with the R&D and MSAT team to bring new products into production, optimize existing production processes, and with the Quality team to ensure the highest standards are maintained.•Identify cost reduction opportunities while maintaining product quality.•Develop and mentor the production team, fostering a culture of continuous improvement.
Raw materials, consumables, and asset management
•Collaborate with Warehouse personnel to handle Raw Material, Consumables, and Final Product inventory management in Manufacturing•Upkeep of equipment (validation, calibration,etc.)•Coordinate with Production Planning, Facilities, and MSAT for production readiness
Support cGMP compliance requirements
•Writing/editing/reviewingWork Instructions as necessary•Assist in coordinating the creation of batch records, work instructions, protocols, specifications, and relevant business documents for production•Coordinate process/method validation and optimization in Manufacturing
Management Duties
·Manufacturing Point of Contact during tours·Establish and drive department KPIs/metrics within software platform·Lead Safety Committee and maintain a culture of safety and inclusivity·Develops solutions to a variety of complex problems; ensures solutions are consistent with organizationobjectives·Manage team in a cleanroom setting·Manage projects while interacting with other
Qualifications:
EDUCATION:BS/BA in Physiology/Cell Biology or 10 years’ experience in variable custom manufacturing.
REQUIRED EXPERIENCE:·Requires 5 -10 years’ experience in management within biologics, pharmaceuticals or cell culture manufacturing organization·cGMP manufacturing experience a must; biologics or pharmaceutical·Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships.·Strong attention to detail·Ability to exercise independent judgment consistent with Company guidelines.PREFFERED SKILLS:·Excipient Level Manufacturing·Aseptic Fill·EH&S·FDA stringency·Project Management Planning·Validations and Equipment Knowledge
PHYSICAL REQUIREMENTS:·Ability to hear and speak to employees and external associates on the phone and in person.·Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)·Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions·Ability to lift at 25 lbs. to a height of 3-4 feet on a regular basis.
TRAVEL REQUIREMENTS:·May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position.NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Management retains the right to add to or change the duties of the position at any time.
