The position will provide process validation, cleaning validation and troubleshooting support for all equipment/unit operations and processes on site related to bacterial fermentation, protein and polysaccharide purification, and activation/conjugation of vaccine drug substances.
At a minimum, the person should be able to independently execute work, interact with various groups across the organization, be a self-starter, and be able to oversee and lead projects to ensure that the cleaning and/or process is running as intended, that the cleaning/process is appropriately validated and runs continuously in a validated state, and look to identify continuous improvement opportunities.
Although the incumbent may be hired to work primarily in a particular area, they are expected to have the scientific acumen to quickly adapt to cross-functional training as needed to advance pipeline projects. In addition, the position will provide support for process analytics related to CPV. Direct interaction with regulatory authorities during audits.
Knowledge of electronic systems including PDOCs, LIMS, SAP, MS Word and MS Excel will be required as part of the job.
Participate in clinical product transfer, production and capital projects in a technical capacity. Perform technical transfer and process engineering activities by working with senior level colleagues and supervision to implement processes in the manufacturing areas. This may include assisting in technical transfer of processes from development laboratories and small-scale pilot areas into the clinical production areas, as well as technical transfer from clinical to commercial facilities.
As vaccine candidates progress through the research pipeline from development through Phase III clinical production, the incumbent will work with internal and external development colleagues to map processes to the manufacturing facilities. This includes the following which may be performed in collaboration with or guidance from senior level colleagues:
Analyze root causes of process problems including but not limited to equipment failure, instrument malfunction, automation changes, and recommend technical solutions.
Develops guides and executes implementation of solutions to complex process engineering problems.
Lead the revision process of documents as they evolve during the technical transfer and development process. Track approval of new and revised documents through the QA document approval process.
Collaborate with development personnel during engineering practice runs to introduce a variety of product candidate processes into clinical production areas through effective process scale-up and troubleshooting activities. This includes adjusting process parameters as necessary during engineering runs and pursuit of any necessary equipment/automation refinements to ensure optimized process performance prior to demonstration runs.
Maintain careful and accurate records of process and analytical data and findings on development projects. Utilize data and findings to contribute to meetings and make presentations on specific process issues. Provide observations/comments during schedule planning and process development meetings.
The incumbent will also perform real-time troubleshooting of equipment and process operations to ensure successful batch completion.
Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to manufacturing. Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities. Review company and site-specific SOPs, policies, and procedures and develop processes that meet the quality requirements set forth in these documents.
Bachelor's degree in Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related field or engineering discipline required.
4 - 7 years of experience in the Pharmaceutical industry required.
Equivalent combination of education (graduate/advanced degrees) and experience will be considered.
Experience with FDA and EU licensing and inspection required.
Experience with Technology Transfer and Project Management is required.
Direct knowledge and experience in process and/or cleaning validation within a biopharmaceutical/pharmaceutical cGMP environment is desired.
Additional experience in other areas of validation is a plus.
Position requirements are typical for an office-based work environment. There are no unusual requirements for this position.
Other Job Details:
Last Date to Apply for Job: 13 AUGUST 2020
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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