Director, DP MSAT

AbCellera Biologics Inc.; United States; On-site; USD 140,000 - 176,000; Full time

Benefits offered by this job

Equity

Annual bonus

RRSP contribution

Job summary

AbCellera Biologics Inc. is seeking a Director, Drug Product (DP) MSAT to lead the Manufacturing Sciences and Technology strategy for biological drug products.

You will be the senior technical authority for contract DP and fill-finish manufacturing, directing external partners, technology transfers, and process qualification. You will also author reports, design sampling plans, and oversee investigations and CAPA with CDMOs.

Qualifications

• 15+ years of industry experience in DP development and manufacturing.
• Experience with monoclonal and/or bispecific antibodies.
• Deep knowledge of GMP requirements and regulatory principles.
• Proven track record managing CMOs/CDMOs and external partners.

Responsibilities

• Serve as senior technical authority for DP/fill-finish manufacturing.
• Direct technology transfer to external facilities from strategy through execution.
• Approve CDMO batch documentation and qualification protocols.
• Drive process performance and data-driven decision making across teams.
• Draft regulatory filings and respond to information requests.

Skills

DP development

Manufacturing

Monoclonal antibodies

CMO management

Education

Bachelor's degree in science/engineering

Job description

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.

We're looking for a Director, Drug Product (DP) MSAT to define and lead our Manufacturing Sciences and Technology strategy for biological drug products. In this role, you'll serve as the senior technical authority for contract drug product and fill-finish manufacturing, setting the strategic and technical direction for external manufacturing partners across new product introductions, technology transfers, process performance, and complex issue resolution. You'll carry final accountability for batch documentation approval, technical report authorship, sampling plan design, and equipment and process qualification, while holding CDMOs and vendors to rigorous technical and delivery standards. You'll also bridge internal development, procurement, and regulatory functions, shaping raw material and equipment requirements and contributing directly to regulatory filings and agency responses. If you thrive on solving complex technical challenges, leading through influence, and helping a growing biologics program take shape, we'd love to hear from you.

How you might spend your days

• Serving as the senior subject matter expert for DP/fill-finish manufacturing processes and technologies, guiding external manufacturing, new product introductions, technology transfers, and the resolution of complex process issues across the biopharmaceutical DP portfolio .
• Directing technology transfer of drug product manufacturing processes to external manufacturing facilities, from strategy through execution
• Owning final review and approval of CDMO cGMP batch documentation (master batch records, component specifications, protocols, material specifications, etc.) required to support cGMP production
• Driving process performance improvement in close collaboration with internal and external teams, setting the technical direction for how performance is measured and advanced
• Authoring and approving DP technical reports (process characterization, /protocols, and validations) in support of cGMP activities and licensure
• Directing the development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability, and related activities.
• Leading equipment selection, qualification, and start-up activities, and ensuring manufacturing partners operate with robust, well-established procedures
• Providing senior oversight of CDMO investigations, root cause determination, and CAPA identification and implementation for manufacturing deviations
• Partnering with DP development and procurement teams to define technical requirements associated with raw materials, components, equipment, and services, and holding external vendors accountable to delivery timelines
• Contributing to the drafting of regulatory filings and providing expert response to regulatory information requests

We’d love to hear from you if

• You have 15+ years of industry experience in DP development and manufacturing of monoclonal and/or bispecific antibodies, and a bachelor's degree in science or engineering discipline; device and combination product experience a plus
• You have outstanding command of the scientific and technical principles underlying drug products and aseptic fill-finish operations for vial and prefilled syringe presentations
• You have deep knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation and qualification principles, and apply sound judgment in ambiguous or high-stakes situations
• You have significant experience in pre-formulation and formulation methods supporting t pre-clinical and clinical programs
• You have a track record leading technology transfer and scaling monoclonal antibody processes; experience with late stage development of biologics and licensure is a plus
• You have proven experience managing and partnering with CMOs/CDMOs, including holding external partners accountable to technical, quality, and timeline commitments
• You are passionate about building capabilities from the ground up, and thrive on establishing new functions that accomplish important goals
• You are a creative, forward-looking thinker who anticipates issues before they arise and sets others up to do the same
• You bring strong operational and risk management acumen, and drive data-based decision making across teams

What we offer

AbCellera’s hiring range for this role is CAD $200,000 - $250,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.

You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials.

About AbCellera

Creating medicines is the most important work we can do.

We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline.
Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications.

We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.

We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines.