Scientist/Senior Scientist, Upstream, Process Development & Manufacturing (Biologics)

Job Title: Scientist/Senior Scientist, Upstream, Process Development & Manufacturing (Biologics)  

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

Position Overview: 

We are seeking an experienced and motivated Scientist/Senior Scientist to support upstream manufacturing activities. This role will be instrumental in contributing to process development and delivery of clinical trial material 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 support CMC strategy 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

• Support cell culture process development and manufacturing activities at external CDMOs.
• Execute and support upstream process development, scale-up, and tech transfer to enable drug substance supply.
• Partner closely with CDMOs to execute fit‑for‑purpose upstream processes aligned with development timelines.
• Support planning and execution of drug substance manufacturing campaigns, including batch record review, sampling plans, deviations, investigations, and change management.
• Serve as person‑in‑plant (PIP) during key manufacturing campaigns to support real‑time issue resolution.
• Identify and mitigate technical and development risks using phase‑appropriate strategies.
• Manage upstream timelines and deliverables to ensure on‑time material delivery and effective cross‑functional handoffs.
• Apply phase‑appropriate QbD principles and analyze process data to support development decisions.
• Contribute to upstream sections of regulatory submissions (INDs, IMPDs).
• Travel up to 20–25% to support CDMO activities.

Qualifications

• PhD or Master’s degree in Engineering or Biological Sciences with ~3-5 years of experience in upstream process development and/or manufacturing of biologics.
• Strong hands‑on expertise in CHO cell culture process development, scale‑up, media optimization, and bioreactor operations; mAb experience preferred.
• Solid understanding of upstream process parameters, product quality attributes, and troubleshooting in clinical manufacturing.
• Experience supporting or leading upstream tech transfer to CDMOs.
• Familiarity with phase‑appropriate cGMP and development regulatory expectations.
• Demonstrated ability to analyze and interpret process and manufacturing data.
• Exposure to upstream process characterization (PC) and process performance qualification (PPQ) is a plus
• Strong written and verbal communication skills and ability to work effectively with cross‑functional and external partners.
• Self‑motivated, execution‑focused, and comfortable operating in a fast‑paced, early‑stage biotech 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 $130,000 to $208,000. 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.