12 days old

Cell Culture Process Scientist

Pfizer
Grangeville, ID 83530
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Closing date for applications is 25th October



**Cell Culture Process Scientist - Grange Castle, Dublin**

This is an ideal development opportunity to join a dynamic team who provide process science support to the ongoing requirements of the manufacturing area and support process transfer projects into the manufacturing suite. The cell culture process scientist is responsible for providing technical support to the operating unit ensuring that the upstream processes are robust, appropriately validated and run to maintain that validated state. This role focuses on process monitoring and troubleshooting, including leading and resolving technical issues and process investigations, implementation of cost reduction projects, and support process transfer projects including facility and equipment design specification.

The job-holder works with the Technical Services teams to deliver integrated technical services to meet the site business objectives. The role requires the flexibility to move from one project quickly or to work on multiple smaller projects at the same time.



Our Culture is hugely important to us at Grange Castle. It is the embodiment of how we act, lead and engage with people every day. Our vision is, together, we deliver life changing medicines to our patients. Our success is achieved through the commitment, engagement and excellence of all our colleagues.



**Job Responsibilities:**

This is a non-laboratory based role, providing cell culture technical support to the protein drug substance manufacturing facility;

Support major investigations, including preparation of process impact assessments;

Provide technical oversight of routine process monitoring and follow-up on any significant adverse trends;

Support introduction of new raw materials or consumables and assessment of Supplier Change Notifications (SCN's);

Execute Annual Product Quality Reports (APQR) and process capability analysis on commercial processes, on a periodic basis;

Implementation of process improvements (yield / robustness / cycle time / cost reduction);

Process validation execution in support of major process changes;

Strong understanding of 6-sigma principles and data analytics;

Regulatory inspection support and close-out of regulatory follow-up measures;

Process equipment design, including development of user requirement spec;

Introduction of new technology, including process analytical technology (PAT).



**Qualifications / Experience:**

Minimum qualification of a B.Sc./M.Sc. or higher qualification in chemistry, biotechnology or a related discipline;

Minimum of 3 years in a GMP manufacturing environment within a regulated pharmaceutical industry, ideally in the Biopharmaceutical industry;

Strong background in mammalian cell culture. Protein purification and /or validation would be an advantage.



**Skills:**

Demonstrated technical capability and aptitude for technical learning;

Strong evidence of problem-solving/trouble-shooting skills;

Ability to independently plan and perform work assignments, interpret and present data;

Capability of working in a multi-disciplinary team environment;

Strong interpersonal skills with an ability to work independently across sites and teams;

Highly motivated, proactive and persistent;

Effective communication (verbal, written).



\#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Engineering
Posted: 2020-10-14 Expires: 2020-11-14
Sponsored by:
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Cell Culture Process Scientist

Pfizer
Grangeville, ID 83530

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