Analytical Development Technical Manager (430)

Location
Malborough, Massachusetts, United States
Posted
Aug 21, 2019
Ref
430
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Equal Opportunity Employer

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