Induce Biologics Inc. is a preclinical stage company developing novel medical devices containing recombinant human growth factors for bone regeneration. We are currently looking to hire a Manufacturing Manager to join our team as we prepare for a clinical trials submission. They will work as part of the manufacturing team that includes the Chief Scientific Officer (CSO), Director of QA and several consultants with area specific expertise. The Manufacturing Manager will report to the CSO.
- Oversee the implementation of the manufacturing process for Induce’s products.
- Develop and monitor key performance indicators. Work with the manufacturing team to address performance issues. Follow up to identify root causes and the corrective actions required to prevent their reoccurrence.
- Create and manage master production planning schedules and ensure successful execution of the plans at multiple contract manufacturing sites.
- Manage all supply chain operations functions, liaise with suppliers, contract manufacturers (CMOs) and with Induce quality assurance and finance to ensure product development and manufacturing timelines are met on-time and on-budget using planning strategies.
- Work with vendors to facilitate issue resolution and problem solving.
- Design and maintain production planning processes, including creation and maintenance of bills of materials (BOMs), master recipes, material masters, and resources. Work proactively to optimize processes through creative solutions, acting alone and/or on teams.
- Identify potential risks/issues that may impact timelines and propose mitigation strategies. Make recommendations to improve timelines for work stream completion.
- Assist in the identification and evaluation of suppliers and CMOs and the development of master services and quality agreements with vendors.
- University degree in the sciences or engineering.
- P.Eng. preferred.
Knowledge, experience and abilities
- 5+ years of relevant experience in manufacturing of biologics, pharmaceuticals or food products in an FDA/Health Canada or EMEA regulated environment.
- Minimum of 1 year in manufacturing planning environment required.
- Previous CMO and supplier management experience is required
- Good project management skills and/or substantial exposure to project-based work structures.
- Excellent written and verbal (English) communication and negotiation skills.
- Must be self-motivated, proactive, organized, and have the ability to deal with ambiguity and be able to manage changing priorities.
- Possess excellent analytical, problem solving and decision making skills. Possess the ability to make timely, effective, fact-based decisions.
- Must be able to develop strong relationships with the vendors while managing the vendor to the contract and being creative when contracts don’t address certain issues.
- Must have the ability to ability to influence and negotiate win/win solutions both within and across organizations.
- Knowledge of protein purification and or bioreactor / cell culture desirable.
Only applicants selected for an interview will be contacted.
Indeed - 2 years ago