Analytical Development Technical Manager (430)
- Employer
- Nitto Avecia Pharma Services
- Location
- Malborough, Massachusetts, United States
- Start date
- Oct 19, 2019
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- Discipline
- Science/R&D, Bioanalytical Services, Chemistry
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
Purpose of the Position:
The Technical Manager is responsible for managing instrumentation and documentation needs across the Analytical Department to support research and development projects primarily focused on oligonucleotides.
Key Job Responsibilities:
Perform technical writing, editing, and proof-reading of analytical documentation
Conduct GDP and technical review of analytical documentation and data packages
Coordinate with stakeholders throughout the documentation review cycle using the Pilgrim EDMS system
Coordinate and perform instrument troubleshooting, repair and qualification activities
Develop and manage training calendar and training modules for department
Develop and manage metrics for instrumentation and documentation by identifying and tracking key performance indicators (KPI) for the department
Communicate effectively across all levels of the organization
Job Knowledge Required:
BA/BS with 5+ yrs. of related experience
Knowledge of analytical chemistry instrumentation theory and operation with demonstrated knowledge and experience troubleshooting and resolving common instrumentation (hardware and software) issues for fundamental equipment and instruments including balance, pH, UV, U/HPLC and MS systems (multiple vendor platforms desired)
Knowledge of cGMP and GDP requirements for the pharmaceutical industry
Excellent technical writing and proofreading ability with demonstrated proficiency in English
Advanced Word, Excel and PowerPoint skills including the ability to perform manual calculations
Statistical analysis and trending of analytical data
Excellent verbal communication skills
Excellent organization and time-management skills
Specific analytical documentation experience (methods, protocols, and reports) and regulatory knowledge are highly preferred
Ability to train/mentor is desired
Company
With over 25 years of experience in oligonucleotide development and production, and over 1000 sequences manufactured, Avecia has played an integral role in the advancing oligo therapeutic market. Our mission is to continue to build value for our customers, as they progress through drug development into commercialization. And as a member of the Nitto Denko Corporation (www.nitto.com), Avecia is committed to the future of the oligonucleotide market. We are driven by innovative ideas and flexible solutions, designed to provide our customers with the best in service, quality, and technology.
Additional locations:
33 Locke Drive
Marlborough, MA 01752
8560 Reading Road
Cincinnati, OH 45215
Tel: (513) 679-3000
- Website
- http://www.avecia.com/Avecia/
- Mini-site
- Nitto Avecia Pharma Services
- Phone
- +1-949-951-4425
- Location
-
10 Vanderbilt
Irvine
CA
92618-2010
US
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