Associate Director, Analytical Development, Tech Ops (Biologics)

Job Title: Associate Director, Analytical Development, Tech Ops (Biologics)

Location: Hybrid - Waltham, MA. Candidates will be required to be in-office 3 days/week. Open to remote.

Role Overview:

We are seeking an experienced and motivated Associate Director, Analytical Development, Tech Ops (Biologics) to lead the analytical function within the CMC team, in support of early-to-late-stage clinical trials. In this role, you will partner with tech ops and quality teams to ensure phase-appropriate analytical methods are developed, qualified and/or validated for release and stability testing of Oruka assets.

You are an ideal candidate for this role if you enjoy developing, optimizing and trending performance for various analytical assays in support of release and stability testing of biologics. In this role, you will have the opportunity to work to optimize assays from pre-IND through commercialization and manage lifecycle of the assays. You will manage stability studies and collaborate with quality, regulatory and clinical teams as new data arrive and impacts shelf life. This role is highly visible within the CMC team and a pivotal addition to our growing organization where you will play an integral role in supporting multiple programs' analytical activities in support of releasing supplies for clinical trials across US, Canada and EU.

Key Responsibilities:

• Lead external method development, optimization and qualification/validation efforts across liquid chromatography, capillary electrophoresis, spectrophotometric and bioassay (among others) for release and stability testing of clinical trial materials
• Manage multiple non-GMP and GMP stability studies for drug substance (DS) and drug product (DP) batches for multiple programs
• Leverage stability data to project shelf-life of both DS and DP supply through trending analysis
• Develop strategies to establish characterization and comparability packages across various DS/DP lots
• Support process and manufacturing teams towards implementation of relevant analytical methods
• Work closely with cross-functional stakeholders (QA, Regulatory, Clinical Supply Chain) for shelf-life extension of clinical material to support ongoing clinical trials
• Partner with internal and external stakeholders to justify and establish DS/DP protocols and specifications
• Work with CDMO partners to perform root cause analysis and investigations to support OOS/OOT results that may arise during stability studies
• Contribute to IND/BLA sections pertaining to analytical methods, stability studies, characterization and analytical comparability
• Lead the diligence process to select clinical and commercial CDMO vendors
• Partner with operations, legal, and finance groups to finalize confidentiality, master service and contractual agreements
• 20-25% travel in support of diligence and campaign execution at the CDMOs

Qualifications:

• Associate Director: Master's (10+ years) or a PhD (6+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC. Experience with monoclonal antibodies is a requirement.
• Relevant industry experience in method development, qualification, validation and method transfer in support of ongoing development and/or commercialization of biologics.
• Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based)
• Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada, EU, etc.
• Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
• Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies
• Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Must have a creative and strategic attitude with the ability to work in a fast-paced environment.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA is $175,00 to $200,0000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states. Potential for fully remote.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.