Job Title: Director, Analytical Development and Validation, Tech Ops (Biologics)
Location: Hybrid - Waltham, MA. Candidates will be required to be in-office 3 days/week.
Remote may be considered. Role Overview:The Director of Analytical Development and Validation will provide scientific and strategic leadership for late-stage analytical activities supporting the development, validation, and lifecycle management of biologic drug products, with a focus on monoclonal antibodies. This role will lead method validation and comparability efforts in support of BLA/MAA submissions, process changes, and commercial readiness, while partnering closely with CMC, Quality, Regulatory Affairs, and external partners.
The ideal candidate is a hands-on leader with deep expertise in analytical method validation, device functional testing, regulatory expectations for late-stage biologics, and the ability to guide teams through complex technical and compliance-driven milestones. 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 and preparing for commercialization across US, Canada and EU.
Key Responsibilities:- Lead late-stage analytical development activities for biologics, including method transfer & validation for release, stability, characterization and device functional testing assays.
- Provide subject matter expertise for ICH Q2/Q14, USP/EP/JP, and global regulatory expectations related to analytical methods.
- Oversee validation of assays including potency/bioassays, purity and impurities (SEC, CE-SDS, icIEF, HPLC), identity, characterization, residuals and device functional testing.
- Experience with PFS and Autoinjector functional testing is required, including validation per ISO guidance(s).
- Drive analytical strategies to support BLA/MAA submissions, post-approval changes, and comparability studies.
- Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness.
- Support analytical risk assessments, control strategy development, and lifecycle management activities.
- Serve as analytical lead for regulatory interactions, including agency questions and inspections.
- Build, mentor, and lead a high-performing analytical development team (internal and/or external).
- Set technical direction, priorities, and timelines for late-stage analytical deliverables.
- Manage and provide technical oversight to CDMOs and contract laboratories.
- Review and approve protocols, validation reports, development reports, and regulatory documentation.
- 10-20% travel is required for this role.
Qualifications:- Experience with monoclonal antibodies and PFS/Auto Injectors is a requirement.
- Director: Master's (10+ years) or PhD (7+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC.
- 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), device functional testing per ISO guidance.
- Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada and EU.
- Experience managing multiple stability studies, protocol development and performing trending analysis, OOS/OOT investigations, root cause analysis, etc.
- Experience with late-phase comparability studies, especially geared toward commercialization.
- 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 $213,000-240,000. 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.
Salary Range for the Role
$213,000-$240,000 USD
What We Offer:- A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
- Competitive salary and benefits package.
- A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
- Opportunities for professional growth and development.
