Process Transfer Coordinator II
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
About this opportunity :
In this role you will manage technology transfer activities for the manufacture of oligonucleotide active pharmaceutical ingredients.
Key Responsibilities:
- Lead and manage all Technology Transfer technical aspects for oligonucleotide projects from process development to oligo manufacturing Oligo Platform approach manufactures and any cross-site technology or process transfers
- Evaluate document and review oligonucleotide compounds physical attribute and modality for occupational exposure banding (OEB) and facility risk including cleaning and carryover.
- Interpret development plans external tech transfer documents or master batch records to generate accurate forecasts for GMP raw material needs.
- Prepare and maintain enterprise resource planning (SAP) inputs for all active GMP manufactures executed or upcoming.
- Lead and manage the interface between Supply Chain (SC) Process Development Quality control/Analytical Development (QC/AD) Environmental Health and Safety (EHS) and Oligo Operations (OPS) to ensure successful technical transfer of scale up and cGMP projects in manufacturing.
- Responsible for the preparation of technical transfer documentation raw material forecasting planning review process transfer related deviations and campaign summary reports.
- Provide oversight over all general Validation activities that cover cross-departmental functions (with support from ENG departments at both sites)
- Actively communicate appropriate information to representatives of SC QC/AD Business Development/Project Management OPS Quality Assurance EHS and Facilities to enable efficient execution of work activities.
- Report status of assigned activities to project teams and to Process Development leadership on a weekly basis or as needed.
- Lead on-boarding activities for new hire employees as well as process training for organizational representatives and possibly clients.
- Maintain an appropriate level of training on company and departmental procedures as determined by Avecia Process Technology.
- Adhere to all company environmental health and safety policies.
Job Knowledge Required:
- BS in Chemistry Engineering or similar study and 3-5 years of experience in synthetic organic chemistry within a chemical development or manufacturing environment.
- Broad knowledge of organic chemistry procedures concepts and literature.
- Experience in CMO environment with emphasis on technology transfer or CMC is strongly encouraged. Oligonucleotide experience is preferred.
- Strong understanding of GMP requirements.
- Demonstrated proficiency in preparation of technical presentations reports and publications.
- Proficient with Microsoft Office especially Excel.
- Experience with SAP is recommended.
The annualized salary range for this position is $83500.00 - $102200.00.
Required Experience:
IC
Key Skills
- Forklift
- Hand Tools
- Distributed Control Systems
- Basic Math
- Mechanical Knowledge
- Live Chat
- Plastics Extrusion
- Microbiology
- Sanitation
- cGMP
- Manufacturing
- Word Processing
About Company
At L3Harris, we anticipate and mitigate risk with agile end-to-end solutions that meet our customers' mission-critical needs across all domains.
