(Sr.) Manager, QC Analytical Development
Location: United States (Remote)
Science/ Focus: Protein Therapeutics
Therapeutic Area: Hematology
Job Overview: As the Senior Analytical Scientist Consultant, you will oversee various analytical projects and ensure that assays comply with all regulations and guidelines, supporting clinical studies, product licensure, and commercialization.
Primary Job Responsibilities:
- Prepare, review, and edit protocols, reports, and documentation for method transfer, qualification, and validation
- Provide technical expertise and guidance on biopharmaceutical analysis and product characterization, and present findings to senior management
- Review data, chromatograms, and GMP packages for assay accuracy, provide troubleshooting and improvement recommendations, and support regulatory interactions and submissions
- MS or PhD degree in Analytical Chemistry, Biochemistry, or a related discipline with a minimum of 4 years of experience
- Previous direct experience working with oligonucleotides
- Proficiency in analytical methods such as HPLC, MS, LC-MS, UV, and NMR; familiarity with bioassay and potency assays
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity 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 us.
EEO Employer
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 employeeservices@apexsystems.com or 844-463-6178.