Senior Validation and Laboratory Operations Manager
hace 3 días
This role is with Danaher, an inclusive employer and a member of the LGBTQ+ business community.
Please do not contact the recruiter directly.
At Cytiva, you will be part of a team that provides new solutions to transform human health.
Our customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
As a Senior Validation and Laboratory Operations Manager, you will lead paid service customer-specific technical projects, working directly with external Biotech customers and internal commercial teams.
You will be responsible for generating specific test protocols and reports to support customer requests and assigned responsibility for intermediate to complex projects.
This position is part of the BIS-PDVS and will be fully remote.
Key Responsibilities:
- Lead, delegate, and review projects of intermediate to complex complexity with no guidance and direction.
- Co-Lead or Lead Technical consultation with customers (internal and external), involving validation testing plans and data review, test recommendations based on regulatory knowledge and expectations, leveraging SMEs.
- Lead team collaboration and communication, with the lab team to ensure all test requirements are in place.
- Travel to customer site for technical meetings and co-lead or lead customer trainings/presentations, using SMEs.
- Establish project priorities and decide appropriate action required to meet required target dates / Schedule work into the laboratory in conjunction with the laboratory team leaders.
- Ensure all projects meet or exceed on-time-delivery expectations by the team.
- Update management of status of assigned projects, including completion, delays or problems - lead development and implementation of countermeasures.
Requirements:
- Bachelor's, Masters Degree or PhD in Science or Life Science.
- Long standing years of working experience in the biotech industry.
- Background in Microbiology and Chemistry Validation testing with an understanding of Filter/Filtration concepts.
- Skilled in advanced laboratory techniques and measurement methods / Ability to perform complex test work / Application of GLP as appropriate and familiar with GMP requirements.
- Fluent in English (reading and writing).
- Ability to travel - 10% travel, overnight.
- Must have a valid driver's license with an acceptable driving record.
At Cytiva, we believe in designing a better, more sustainable workforce.
We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.
This position is eligible for a remote work arrangement in which you can work remotely from your home.
Additional information about this remote work arrangement will be provided by your interview team.
Explore the flexibility and challenge that working for Cytiva can provide.
This job is also eligible for bonus/incentive pay.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
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