Lead Specialist, Quality Assurance Validation
One of the top Biotech companies in Cambridge is looking for a Lead Specialist to work with our QAV team and help with their novel gene therapy. You must be able to give guidance as well as technical review of all the protocols and reports related to process characterization, test methods, technology transfers, and process validation activities. These activities will include commercial projects, as well as both pre-clinical and clinical projects.
What you'll do
- Must have the skill to exercise proper judgement within and outside of defined procedures and practices in order to choose appropriate action.
- You will give support and guidance in the development and execution of CxO validation/ qualification documentation.
- You will give support and guidance for the data analysis, execution, development and reporting of external clinical and commercial protocols as needed.
- You must be able to multitask and prioritize independently while in a high paced environment.
- You will be expected to help the development of long-range goals and objectives.
- You will represent the QAV group in project teams.
- You will be expected to give QAV support to Tech Transfer and CMC teams.
- You should have a good understanding of FDA as well as foreign requirements and expectations.
- You should have a minimum of 6 years of experience in the Biotech industry (preferably all clinical phases through commercial drug product).
- You should have either a Bachelors or a Master's degree in Biochemistry or engineering.
- You will need to have a broad range of experience across validation disciplines including method validation, cleaning validation, and process validation.
- Must have a good understanding of cGMP guidelines, ICH Q7, Q8, Q9, Q10 as well as other international regulatory requirements that would be relevant for process, equipment validation and cleaning.
- Must be competent with Microsoft office (Word, Excel, PowerPoint, Outlook, MA Project)
- Must have experience with support of Tech Transfer initiatives.
- Must have leadership skills to lead cross functional teams, as well as excellent written and verbal communication skills.
- Must have shown experience demonstrating risk based approaches (PHA, FMEA, etc).
Sthree US is acting as an Employment Business in relation to this vacancy.