Head of Analytical Development & Quality Control
AD/ Director of Analytical Development (Cell Therapy) 1346895
Location: Boston area (Onsite)
Science/ Focus: Cell Therapy
Job Overview: This key individual will lead method development and optimization efforts for the testing cell therapy products including method qualification and validation, method transfer to external test labs, and management of analytical development team.
Responsibilities:
- Oversee and manage the Analytical Development team, support analytical testing for development teams, manage tech transfer of new methods to QC team and provide oversight of external test labs.
- Collaborate closely internally and externally to provide effective technical and business leadership between R&D and CMC efforts.
- Develop and communicate budgets, project timelines, and risk mitigation strategies
Requirements:
- PhD with 10+ years of relevant experience or equivalent expert knowledge in analytical development.
- Extensive hands on experience in analytical method development to characterize cell & gene therapies using FACS/ Flow Cytometry methods and qPCR or ddPCR
- Experience drafting technical reports and GMP documentation.
- Experience with automated assay workflow preferred
About Stratacuity:
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.