Associate Director, Analytical Development

The Associate Director, Analytical Development, Oligonucleotides leads analytical development and supports quality control strategies for oligonucleotide and small-molecule intermediates across clinical development, registration, and commercialization. This role provides strategic and technical leadership for analytical method development, validation, technology transfer, specifications, release testing, stability programs, impurity control, and product characterization. The position is full-time, based in Waltham, MA, without the possibility of being remote. Physical presence onsite is expected on 4-5 days/week.

Responsibilities

Lead analytical development and quality control strategies for oligonucleotide and small-molecule intermediates from early clinical development through commercialization; Serve as the analytical SME and strategic lead for internal and external activities related to analytical operations of linkers and oligonucleotide intermediates; Responsibilities include analytical development of drug substance intermediates including method development, validation, characterization, tech transfer, specifications, release, and stability testing; Assist with developing the analytical/QC strategy for small molecules and oligonucleotides guided by ICH framework; Develop, review, and approve method transfer/validation protocols and validation approaches; Support establishment of critical quality attributes and phase-appropriate specifications; Advise and plan extended characterization of drug substance intermediates to expand product understanding; Partner with QC and QA to provide oversight of cGMP activities and documents (change controls, deviations, CAPAs, procedures, QC raw data review, batch release support, stability protocols and programs, validation protocols, etc.); Oversee Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate; Lead, author, approve, or provide strategic direction for CMC analytically focused documentation for biologic INDs and BLAs and support FDA and EMEA interactions; Work with partner organizations to ensure timelines are met, milestones and products are delivered on schedule, and excursions, deviations, investigations, and CAPAs are addressed and closed within target timeframes; Provide oversight of CDMOs, contract testing laboratories, and other external partners

Requirements

A minimum of 8 years in Analytical Development and/or Quality Control; Bachelor's or master's degree in biology, biochemistry, chemistry, or similar related field required; Knowledge of a variety of analytical techniques including liquid and gas chromatography, NMR, Karl Fischer, CD, AEX, chiral separations, RP-HPLC, and mass spectroscopy; Strong quality and analytical background with experience in general, compendial and product-specific analytical tools and practices pertinent to small molecules and oligonucleotides; Experience with impurity control strategy including novel approaches for impurity detection, impurity ID and characterization for oligonucleotides/small molecules; Experience with managing external vendors required; Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues; Strong knowledge of cGMP/ICH/FDA/EU regulations; Ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods; Excellent interpersonal, organizational, negotiation, and communication skills; ability to work collaboratively with colleagues across functions; Ability to travel (up to ~10%)

Nice to have

Experience with monoclonal antibodies or ADCs (mab-conjugates) and relevant analytical techniques; post-approval experience; international experience; negotiation experience with regulatory authorities