Position Summary
Our client is seeking to recruit a contract upstream and/or downstream technology transfer MT engineer. The Manufacturing Technology group are responsible for process validation and continued process technical support to cell culture and primary recovery unit operations for the commercial manufacture of multiple mammalian cell processes in the Multi Product Cell Culture facility. The successful candidate will be key contributor to a dynamic and highly technical global team. This position will build collaborations with Manufacturing, Engineering, Quality Assurance, Quality Control and Global Regulatory Sciences groups.
Key Responsibilities
* Deliver tech transfer readiness activities from facility assessment through to PPQ execution and report completion for a new product introduction to the clients site.
* Have a thorough knowledge of the science behind the molecule and associated drug substance manufacturing processes with fundamental knowledge of the following relevant principles:
* Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
* Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
* To identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools.
* To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
* To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
* Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Clients site.
* Document and appropriately communicate aspects of work and learnings at internal and external fora (may include participation at scientific meetings)
* Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives at site.
Qualifications & Experience
* Minimum BSc or equivalent with at least 3 years' experience in drug substance manufacturing technical support in the biopharmaceutical industry including tech transfer preparation, execution and post-execution activities.
* You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
* Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings.
* Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form.
* Can effectively partner with and influence stakeholders without direct solid line authority.
* Drives technical decisions balancing product quality and operational requirements.
Please note that this role may infrequently require periods of extended hours or a modified work schedule and may require on-call availabilit
