Responsible for manufacturing support of late stage biologics processes. Subject matter expert for cell culture and/or purification process unit operations and equipment. Provides rapid response to operational issues and supports ongoing operations including new product introduction, process optimization, monitoring and cleaning. Provides leadership, training and coaching of manufacturing personnel. May lead of team of 1-3 direct reports.
- Responsible for biologics manufacturing process technical support and improvement initiatives for ongoing operations. May have responsibility for operations encompassing all aspects of cell culture and/or purification depending on required scope and experience.
- Provides leadership to manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site.
- Supports operational efficiency goals for yield, product quality and other product and/or site KPI’s.
- Actively promotes a culture of GMP and EHS compliance with all applicable policies and guidelines and supports risk assessment activities providing relevant technical knowledge.
- Provides support to regulatory filings and audit activities.
- Provides support for process cleaning/changeover strategies (CIP/SIP), media/solution preparation and benchtop analytics as required.
- Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures consistency and quality of the group’s documentation.
- May supervise a team of 1-3 direct reports.
- Any other responsibilities or tasks as assigned by your Supervisor/Manager
- Bachelors / Masters / PhDs degree In a technical/science field, including Chemistry, Biochemistry or Pharmaceutical Sciences
- (Degree) 4 - 8 years / (Master) 2 - 6 years / (PHD) 0 - 4 years of technical experience in Biochemical, Chemical, Engineering science field emcompassing Biotechnology is required.
- Ability to lead a team (either direct reports or indirect stakeholders) and develop employees
- Detailed Knowledge of cGMP and regulatory requirements relating to the biopharmaceutical industry is required.
- Technical experience with process scale-up, bioreactors, column chromatography and packing, UF/DF, filtration technologies and single-use systems all desirable.
- Knowledge of E/F/U validation including cleaning strategies and CIP/SIP.
- Experience with start-ups and new product introduction to commercial facilities is preferred.
- Good problem solving skills and use of tools like FMEA, 5 Why’s with the ability to work under pressure and deliver on tight timelines
- Team player, highly self-motivated and able to work under minimum supervision.
- Good command in oral and technical writing in English, and excellent communication and presentation skills.
Job Type: Experienced