Head, Analytical & Quality Control
Head of Analytical & Quality Control (Small Molecule) 1318682
Science/ Focus: Small Molecule
Therapeutic Areas: Stealth
Job Overview: This small-molecule focused Head of Analytical and QC will be responsible for leading analytical development and QC-related activities across all phases of development and collaborate closely with discovery, toxicology, manufacturing, and regulatory, to advance a fast-growing and exciting team.
- Lead the drug substance and drug product analytical chemistry efforts by developing phase appropriate approaches to support the development of preclinical and clinical stage programs
- Provide analytical development support to the internal small-scale process chemistry and pre-formulation/formulation efforts as well as manage third party laboratories
- Manage activities at CMOs related to analytical method development, troubleshoot OOS/OOT investigation, method qualification/validation, specification setting, impurity characterization, and stability studies for starting materials, intermediates, drug substances, and drug products.
- Support vendor selection and provide technical assistance during QA vendor audits.
- Author analytical chemistry sections to be included in regulatory filings.
- PhD with 12+ years of relevant small molecule analytical chemistry experience in the pharmaceutical industry
- Proven track record in managing analytical aspects of development programs in clinical stage, commercial, and QC experience
- Experience with sterile products and oral dosage forms preferred
- Successful in developing and broadly communicating cross-functional technical strategy and direction in support of CMC deliverables
- Broad understanding of analytical sciences and regulatory/GMP requirements and a proven track record in analytical development for clinical-stage programs.
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.
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Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.