Director, Analytical Development

Your Contribution Partner with global team leads to develop and implement robust method development processes and analytical control strategies Identify analytical risks and data gaps; design and execute mitigation studies (comparability, forced degradation, structure-function analysis, stability testing, investigations) Establish internal best practices and analytical playbooks Support definition of CQAs and associated control strategies through experimental studies across phases Provide technical input for CMC documentation (IND/IMPD, BLA/MAA) on analytics, product characterization, and investigations Lead technical experts in hands‑on laboratory work including method development, troubleshooting, and lifecycle management A Good Match PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences (or related) with 10+ years relevant experience, or MS with 12+ years industry experience Extensive experience in global pharma AD/AS&T for monoclonal antibodies or ADCs; late-stage clinical manufacturing/BLA readiness preferred Hands‑on expertise in biologics method development, qualification/validation, transfer processes; ADC‑specific analytics desirable Strong understanding of biologics CMC guidelines (e.g., ICH Q6B), QbD principles, PPQ/BLA readiness, specification setting and justification Proven leadership experience in cross‑departmental environments; excellent communication skills Preferred: global regulatory experience (US/EU/China) Your Benefits Medical, Dental and Vision Insurance Life, AD&D, Critical Illness Insurance Pre‑tax HSA/FSA, DCRA spending accounts EAP (24/7) Parental/Childbirth leave Paid Time Off 401(K) with company match Tuition reimbursement Professional development Commuting allowance and subsidized parking Discounted home/auto/pet insurance Apply now Submit documents via the online form for the Gaithersburg, US location. #J-18808-Ljbffr