Scientist, Analytical Development
Location: Waltham, MA (Hybrid)
Therapeutic Area: Gene Therapy
Job Overview: This position seeks a passionate analytic scientist with CMC expertise to develop gene therapy technology, handling analytical technology transfer and regulatory compliance in a collaborative, values-driven team.
Primary Job Responsibilities:
- Lead analytical technology transfers, collaborating with teams and mitigating risks.
- Validate analytical methods following regulatory guidelines for accuracy and precision.
- Ensure analytical activities comply with regulatory standards and prepare submissions.
- Manage timelines, resources, and budgets for projects, reporting progress to management.
- PhD, M.Sc, or B.Sc in analytical chemistry, polymer science, biochemistry, or biotechnology, coupled with relevant industry experience in Pharma/Biotech. Skilled in GMP analytical method development for biologic product quality control.
- Proficient in various analytical instruments and familiar with regulatory compliance.
- Strong analytical and communication skills, with proficiency in statistical software.
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.