Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)late

Job Title: Associate Director, Downstream, Manufacturing Sciences and Technology (Biologics)        

Location: Hybrid – Waltham, MA required to be in-office 3 days/week. 

Position Overview:

We are seeking an experienced and motivated MSAT (Manufacturing Science and Technology) leader to lead downstream late-stage and pivotal enabling optimization, scale-up and transfer of manufacturing activities. In this role, the ideal candidate will be responsible for process development, troubleshooting production issues, data analysis, and ensuring compliance with regulatory standards to maintain product quality. The successful candidate will be involved in late-stage drug substance manufacturing and process validation activities in support of BLA filing. This role involves working in a fast-paced environment and drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of a growing team with an opportunity to contribute towards developing best in class biotherapeutics.  

Key Responsibilities:

• Oversee the transfer of manufacturing processes from late-stage development to large-scale production at the CDMOs for multiple programs.
• Work with CDMOs to identify gaps and implement improvements towards enhancing product quality, robustness, and cost-effectiveness with line of sight to commercial manufacturing.
• Build strong relationships and partner cross functionally with process development, analytical, formulation, quality, regulatory and program management.
• Oversee GMP manufacturing campaigns ensuring seamless execution, timely completion and handoff to drug product manufacturing teams.
• Partner with late-stage process characterization and MSAT teams and develop robust control strategy enabling successful PPQ DS campaigns
• Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.
• Partner with stakeholders to support timely approval and execution of reports, batch records, in-process sampling plans, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.
• Support regulatory filings by authoring high quality reports enabling timely submissions for multiple jurisdictions (INDs, CTAs).
• Perform MFG/MSAT risk assessment activities in a phase appropriate manner ensuring proper measures are in place in support of production and filing requirements.
• 20-25% travel in support of manufacturing activities at CDMOs.

Qualifications:

• Master’s or a PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent with at least 8 years of relevant experience developing, scaleup, and transfer of downstream processes for biologics.
• Significant experience managing manufacturing in an MSAT environment. Direct hands-on experience with monoclonal antibodies is a plus.
• Expertise in purification process optimization with an emphasis on scale-up, scale-down models, process robustness, facility fit and overall commercial readiness.
• In depth knowledge of CMC, quality and compliance, as well as regulatory aspects of biopharmaceutical development and life-cycle management.
• Must have a solid understanding of all downstream unit operations, process parameters, product quality, and troubleshooting strategies enabling successful execution of phase appropriate manufacturing campaigns.
• Demonstrated track record of successful tech transfers to CDMOs with an eye towards late stage and commercial process development.
• Must have direct experience or exposure to transition of processes from early stage to late stages such as process characterization, FMEA and PPQ campaigns, with emphasis on phase appropriate control strategy.
• Direct experience in design-of-experiments (DoE) and robust data analysis via industry standard statistical tools.
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Self-starter with a strategic mindset and ability to thrive in a fast-paced, collaborative 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 $175,000 to $200,000. 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.

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.