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Process Development Associate I, Analytical Sciences
The Development Associate I is responsible for performing assigned experimental and administrative tasks to support the development and optimization of manufacturing processes, analytical/ characterization methods as well as GMP stability and release testing for our client's biotherapeutic candidates. The Development Associate I will work in collaboration with other members of the Global Process Development, Quality and Analytical Sciences departments.
- Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records.
- Perform shipping/receiving duties/testing (as assigned) for in-process, drug substance and drug product release, stability process development samples.
- Perform analytical methods pertaining to gel electrophoresis, HPLC, UV spectrophotometry and ELISA (plate based) assays (as assigned).
- Draft WPDs and SOPs qualification and validation protocols and reports as assigned.
- Compile data and information related to assay and instrument performance.
- Recognize and report aberrant test and sample conditions to the area supervisor / manager.
- Order, stock, receive, label, log, and inventory laboratory supplies.
- Provide laboratory support services, clean/maintain equipment and prepare reagents/solutions.
- Ensure training is current for all job functions performed. Attend all required Company training.
- Provide timely and legible laboratory notebook data or documentation.
- Perform other related duties as assigned
- A successful candidate will typically hold a BS degree in Biochemistry, Chemistry, Chemical Engineering or related discipline from an accredited university.
- A successful candidate will typically have 6+ months of experience working in a relevant laboratory setting
- Follow written procedures when conducting experiments and applying methods
- Document procedures and data in peer-reviewed laboratory notebooks
- Order, stock and maintain inventory of laboratory supplies
- Participate in general laboratory operations including equipment maintenance and organization
- Interact with Technical Operations groups, Research and external vendors
- Communicate findings to colleagues within the group through presentations
- Proficiency with various MS Office programs, including Word, Excel, Outlook, and PowerPoint
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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