Technology Transfer Scientist
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Job Location:
Raritan, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Title: Technology Transfer Specialist (Medical Manufacturing)
Location: Raritan NJ
Duration: 12 Months
Location: Raritan NJ
Duration: 12 Months
Position Summary:
The individual is responsible for the execution of process transfers and launch implementation activities associated with
moving production of Transfusion Medicine Products from their current manufacturing location to alternate sites.
The individual must ensure that key project milestones are met to ensure the overall project goals are met and continuity of
supply to customers is maintained.
The individual is responsible for the execution of process transfers and launch implementation activities associated with
moving production of Transfusion Medicine Products from their current manufacturing location to alternate sites.
The individual must ensure that key project milestones are met to ensure the overall project goals are met and continuity of
supply to customers is maintained.
Major Duties & Responsibilities:
30% Author Tech Transfer deliverable checklists to ensure that all prequisite requirements are in place prior to manufacturing the verification (Transfer)
Validation and launch lots of products. Ensure all objective evidence and supporting evidence is obtained and meets requirements.
30% Ensure receiving site protocols and reports are aligned to the manufacturing transfer plans and that transfer and validation lots meet requirements.
25% Author /update Manufacturing Transfer Plans and Reports related to the alternate site(s)
10% Serve as liason between the current and new manufacturing locations as required.
5% Ensure that all documentation and any updated versions are provided to the alteranate manufacturing locations.
30% Author Tech Transfer deliverable checklists to ensure that all prequisite requirements are in place prior to manufacturing the verification (Transfer)
Validation and launch lots of products. Ensure all objective evidence and supporting evidence is obtained and meets requirements.
30% Ensure receiving site protocols and reports are aligned to the manufacturing transfer plans and that transfer and validation lots meet requirements.
25% Author /update Manufacturing Transfer Plans and Reports related to the alternate site(s)
10% Serve as liason between the current and new manufacturing locations as required.
5% Ensure that all documentation and any updated versions are provided to the alteranate manufacturing locations.
Qualifications
Experience Required/Preferred Degree in Chemistry Biochemistry Biology or similar discipline preferred or minimum of 5 years experience in an Tech Transfer
Operations or Product Development/Support role within a GMP manufacturing facility.
Minimum of 5 years experience in an Operational or Technical environment Demonstrated ability to successfully deliver against project timelines
Track record of contributing to cross-functional teams within a regulated environment.
Experience Required/Preferred Degree in Chemistry Biochemistry Biology or similar discipline preferred or minimum of 5 years experience in an Tech Transfer
Operations or Product Development/Support role within a GMP manufacturing facility.
Minimum of 5 years experience in an Operational or Technical environment Demonstrated ability to successfully deliver against project timelines
Track record of contributing to cross-functional teams within a regulated environment.
Travel:
Predominately site based less than 5% domestic or international travel per year
Predominately site based less than 5% domestic or international travel per year
Key Working Relationships
Identify the most important working relationships with people inside and outside the company including customersvendors associations etc.
Partner with Internal Operations QualitySupply Chain Raw Material supply Engineering R&D External Manufacturing Supplier External Supplier
Identify the most important working relationships with people inside and outside the company including customersvendors associations etc.
Partner with Internal Operations QualitySupply Chain Raw Material supply Engineering R&D External Manufacturing Supplier External Supplier
Comments:
The role will involve meetings with third-party suppliers located internationally primarily in France the UK and Australia.
As a result calls with European suppliers will typically need to be scheduled in the morning EST while meetings with Australia-based
suppliers will occur later in the afternoon or early evening making schedule flexibility essential.
The individual is expected to be on site initially to establish connections with key stakeholders at Raritan.
After this initial period there will be opportunities to work remotely with the role operating in a hybrid model.
The role will involve meetings with third-party suppliers located internationally primarily in France the UK and Australia.
As a result calls with European suppliers will typically need to be scheduled in the morning EST while meetings with Australia-based
suppliers will occur later in the afternoon or early evening making schedule flexibility essential.
The individual is expected to be on site initially to establish connections with key stakeholders at Raritan.
After this initial period there will be opportunities to work remotely with the role operating in a hybrid model.
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
