Job Title: Associate Director, Upstream, Manufacturing Sciences & Technology (Biologics)  

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

Position Overview: 

We are seeking an experienced and motivated Associate Director to lead late-stage upstream manufacturing activities. This role will be instrumental in overseeing tech transfer, scale-up and process validation activities at CDMOs. The ideal candidate will collaborate cross-functionally within the CMC team including downstream, analytical, and drug product and other stakeholders such as QA, regulatory, and program management.  The successful candidate will help shape late-stage CMC strategy, contribute to gap assessments, and support regulatory submissions in a fast-paced, innovative environment. You will be an integral part of a growing team with an opportunity to contribute towards developing best in class biotherapeutics.

Key Responsibilities:

• Serve as a subject matter expert for upstream cell culture development and manufacturing at CDMOs.
• Lead tech transfer and scale-up activities, ensuring robust, consistent, and cost-effective upstream processes.
• Support batch record review, in-process sampling plans, release protocols, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.
• Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.
• Conduct risk assessments and gap analysis to support late-stage development and commercial readiness
• Manage drug substance manufacturing campaigns and timelines ensuring seamless execution, timely completion and handoff to downstream teams.
• Apply QbD principles to define process parameters and product quality attributes that support late-stage process optimization and control strategy.
• Analyze and incorporate data from process and manufacturing runs in relevant regulatory filings.
• Coordinate, review and draft relevant sections of the regulatory filings (IND, IMPD) ensuring timely completion of relevant CMC sections.
• Travel up to 20-25% to support CDMO activities.

Qualifications:

• PhD or Master’s in an Engineering discipline or Biological Sciences field with at least 8 years of experience in upstream manufacturing from relevant work in a manufacturing sciences and technology (MS&T) environment.
• Strong expertise in CHO cell culture, scale up, media formulations and bioreactor operations. Experience developing cell cultue processes for monolclonal antibodies is a plus.
• Must have solid understanding of process parameters, product quality, and troubleshooting strategies enabling successful execution of phase appropriate manufacturing campaigns.
• Track record of successful tech transfers to CDMOs with direct experience in late stage clinical and commercial manufacturing.
• Experience in late stage manufacturing, including process characterization, FMEA, and PPQ campaigns.
• Direct experience in robust data analysis via industry standard statistical tools.
• In depth knowledge of cGMP, ICH, WHO and FDA/EMA guidelines and experience utilizing them in a phase appropriate manner.
• Hands on experience with scale-up/down models, process monitoring, facility fit and overall commercial readiness.
• 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.