Development Associate, In-Process Analytical Method DevelopmentJOB SUMMARY:
Our client is seeking a motivated Development Associate to support the development of analytical methods. In this role, the candidate will follow SOPs; perform, troubleshoot, and help optimization of the analytical methods to support a variety of programs. The ideal candidate will have a fundamental understanding of developing analytical methods that are used for characterization of manufacturing of biologics.ESSENTIAL FUNCTIONS:
- Play a major role in analytical testing for supporting process development under the general supervision of a senior level scientist.
- Assist in development and optimization of novel analytical methods for in-process characterization of AAV-based drug products.
- Perform initial qualification of newly developed assays in preparation for tech transfer to regulated QC environment.
- Work with senior level scientist to ensure required documentation is accurate and complete.
- Contribute to the completion of milestones associated with specific project plans.
- Contribute to routine laboratory organization of samples and reagents and maintenance of lab equipment.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- BS or MS in a Chemistry, Molecular Biology, Biochemistry or equivalent.
- Minimum 2 years of relevant industry experience.
- Fundamental understanding of USP/ICH guidelines for analytical method development, qualification/validation.
- Proven laboratory experience with different molecular biology techniques including and not limited to real-time qPCR, PCR and digital droplet PCR.
- Familiarity with analytical biochemistry and protein-based assays including ELISA, SDS-PAGE, IEF, Capillary Electrophoresis, Western Blots, HPLC, DLS and LC-MS.
- Previous experience in a gene therapy-based drug development and regulated environment is a plus.
- Ability to execute experiments independently, troubleshoot molecular techniques and evaluate data of moderate complexity.
- Detail-oriented, organized with ability to work independently and collaboratively.
- Demonstrated ability to document procedures and results and keep accurate detailed records.
- Effective communication and interpersonal skills.
- Ability to be flexible in a fast-paced and dynamic environment.
- Proficient in standard computer skills, familiarity with data analysis and Statistical analysis software is a plus
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at firstname.lastname@example.org or 844-463-6178.
Posting ID: 559413829Posted: 2020-06-03