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June 24 2018

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Job Opportunity: Technical Services Scientist Downstream Purification:Tandem Project Management

Job description:

Technical Services Scientist Downstream Purification

Tandem Project Management


   » Westmeath
   » Negotiable
   » Contract
   » Updated 14/06/2018
   » Orla this job is expired SaveSave Apply Now

Job detail


Technical Services Scientist Downstream Purification position available in Westmeath now.
 

Summary:
The prosperous candidate will be responsible for providing technology transfer activities for the cGMP Biologics processes. The position will provide downstream processing skills to support the facility design, start-up and routine commercial manufacturing. The Technical Services Scientist will be responsible for supporting technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Process Development, Engineering, Validation, Supply Chain, Quality, Regulatory and other involved departments to ensure prosperous facility design, construction, startup and qualification. The position is accountable for timely completion of technical transfer related milestones, will support technical transfer activities from planning to completion including the oversight of downstream unit operations and will address complex technical problems arising during the technical transfer. regulatory questions.
The main responsibilities are:
   » Provide process skills in the area of buffer preparation and downstream processing / purification to support the client side design team in its efforts connected with the biologics facility.
   » Participate in cross functional downstream design teams as required in support of the company's overall design goals and expectations.
   » Lead and support process risk assessments where required
   » Author and review process transfer documentation, gap assessments, technical reports, process validation documents, and portions of regulatory submissions.
   » Identify requirements for laboratory studies to support facility design decisions or process transfer and to contact closely with process development to supervise the design and execution of studies.
   » Provide technical oversight of routine process monitoring and follow-up on any significant adverse trends.
   » Identify and implement process improvements; e.g. yield, cycle time reduction.
   » supervise the execution of technical studies and validation protocols on the manufacturing floor.
   » Temporary shift working may be required during periods of engineering batch and validation batch execution.
   » Lead manufacturing floor support for troubleshooting and investigations into downstream processes and provide general technical oversight of process.
   » Author and review IND, BLA and other technical documents for regulatory agency submissions.
   » Review and approval of CMC sections for regulatory filing documents and responses to regulatory questions.
Qualifications & practice:
   » Minimum requirement B.Sc in Biochemistry, Biology, Chemistry, Biotechnology or equivalent, or B.Eng. Process or Chemical Engineering.
   » A higher degree (M.Sc. or Ph.D.) would be an advantage.
   » Minimum 3/4 years' practice in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
   » Technical and operational knowledge of multiple unit operations in downstream processing, including buffer preparation, chromatography, ultrafiltration / diafiltration and membrane filtration.
   » Strong knowledge of technology transfer, scale-up and process validation.
   » Comprehensive knowledge of cGMP requirements for commercial biopharmaceutical manufacturing and the capability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
   » capability to present and defend technical and scientific approaches in both written and verbal form.
   » practice of authoring CMC sections of regulatory submissions would be an advantage.
   » capability to influence others without direct authority and communicate with all levels of the organization
   » capability to drive for results independently and adapt to rapidly changing priorities
   » practice of validation / verification of GMP equipment or processes would be beneficial.
   » practice of design, commissioning and start-up of a bulk drug substance facility would be beneficial.
Ref: TPM01378
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Tandem Project Management


   »  


   » Building 1000, Citygate, Mahon, Co Cork
   » 021 240 9055
   » orla.daly@tandempm.ie
   » http://www.tandempm.ie



Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Westmeath
Company Type Employer
Post Date: 06/14/2018 / Viewed 18 times
Contact Information
Company: Tandem Project Management
Contact Email: orla.daly@tandempm.ie


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