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.