Scientist, Downstream, Process Development and Manufacturing (PD/MFG) (Biologics)

Job Title: Scientist, Downstream, Process Development and Manufacturing (PD/MFG) (Biologics)         

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

Role Overview: We are seeking a motivated Process Development individual to lead downstream pre-clinical to early stage enabling process development, optimization, scale-up and transfer of manufacturing activities. In this role, the ideal candidate will be responsible for early-stage process development, tox batch production, optimization, scale up to GMP and late stage pivotal development. The successful candidate will be involved in pre-clinical development to pre-pivotal early-stage development in support of IND 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 pre clinic to early-stage development to 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 clinical manufacturing.
• Build strong relationships and partners cross-functionally with process development, analytical, formulation, quality, regulatory and program management.
• Oversee tox production and GMP manufacturing campaigns ensuring seamless execution, timely completion and handoff to drug product manufacturing teams.
• 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).
• 15-20% travel in support of manufacturing activities at CDMOs

Qualifications:

• Bachelor’s or Master’s degree in Biochemistry, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 4 years of relevant industry experience in the development, scale-up, and technology transfer of downstream processes for biologics.
• Significant laboratory experience with early-stage development. Direct hands-on experience with monoclonal antibodies is a plus.
• Expertise in purification process optimization with an emphasis on scale-up, process robustness, and facility fit.
• Must have a solid understanding of all downstream unit operations, process parameters, product quality, and troubleshooting strategies enabling successful scale up.
• 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.

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 130,000 is $146,000. 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.