MSAT Senior Scientist

MSAT Senior Scientist#25-59072

Dallas, TX

All On-site

Job Description

MSAT Senior Scientist - 12-Month Fixed Term Contract

The MSAT Senior Scientist will provide technical expertise to support the commercial manufacturing of therapeutic proteins in a mammalian cell culture facility. This role will require technical leadership in multiple late-stage programs that involve activities including but not limited to: Technology Transfer, Process Validation (PPQ, CPV), Technical Support and Technical Studies in the MSAT Laboratory. A key requirement for the successful candidate will be the ability to lead tech transfer activities for new products and previous experience in this area will be required. The senior scientist will use his/her previous technical experience and process knowledge to support on-going optimisation of the upstream/downstream process. The ideal candidate will be a key contact in technical troubleshooting of unit operations and leading/supporting major process investigations at the request of the business. The scope of this role will also include designing and executing laboratory experiments in the laboratory to support process characterisation and late-stage process improvements/development activities. The candidate may be required to support both upstream and downstream areas as needed and in line with areas of expertise.

Department Description

As MSAT Technical Services Lead you'll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the Senior MSAT Director. This role is being offered as a 12-month maternity fixed term contract.

Your Responsibilities:

GMP Commercial/Clinical manufacturing experience in a mammalian Cell culture/purification setting (perfusion or fed batch) operations and associated requirements.

Act as an SME for Upstream/Downstream, including technology transfer, process validation, trouble shooting and investigation.

Lead risk assessments in support of New Product Initiation for transferring new products and processes.

Provide Expertise in analytical monitoring; Viable cell density, metabolite and nutrient monitoring, protein concentration, impurity monitoring and clearance and how these relate to cell culture/downstream performance and product quality.

Author or review and approve process validation strategies, protocols and reports.

Coaching of fellow process engineer/scientist and manufacturing personnel to increase technical knowledge of critical process steps and develop plans to build competencies and expertise.

Support and lead scientific investigations ensuring that the true root cause and effective CAPA are identified and implemented.

Performs intermediate level of statistical data analysis with the ability to recognize trends and areas where more analysis should be performed. Performs statistical data analysis, charting, linear regression analysis.

During the start-up phase of the facility this position will also provide support in building the MSAT function in Dundalk, including documentation generation and qualification of the MSAT laboratory equipment.

Designs Experiments for execution of lab studies/analytical work with a high level of autonomy.

Support Health Authority audits.

Perform all duties in accordance with GMP requirements, SOPs and controlled documents

Will be flexible to take on additional tasks and responsibilities at the discretion of their manager

Education:

Doctorate in a biotechnology area ideally or science related discipline is preferable.

Masters/Bachelors in biotechnology or science related discipline with additional experience will be considered.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.