Oruka Therapeutics
Director, Process Development and Manufacturing (Biologics)
Oruka Therapeutics, Waltham, Massachusetts, United States, 02254
About Us:
Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years and have made successful public debuts. We have a lead program that we expect will be in the clinic in 2025 and could offer transformative efficacy for a disease that affects millions of people.
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Position Overview:
We are seeking an experienced and motivated candidate to lead early-stage IND enabling drug substance (DS) process development and manufacturing activities. In this role, the ideal candidate will be responsible for overseeing cell line and process development, tech transfer, scale-up and DS manufacturing at the CDMOs. You will collaborate with groups like analytical, formulation and QC to assist method development, reference standard characterization, release and stability studies. The successful candidate will establish CMC strategy for early-stage process development, perform gap assessment, and provide timely solutions while continuing to plan late-stage development. In this role, you will oversee activities at the CDMO partners to track and ensure timely completion of GMP drug substance manufacturing. This role involves drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of the team with an opportunity to work in a fast-paced environment.
Key Responsibilities:Manage cell line development, clone selection/stability, upstream/downstream development and manufacturing operations at the CDMOs.Optimize upstream and downstream unit operations with an emphasis on robustness, scalability, quality, cost, validation and commercial plans.Lead drug substance manufacturing campaigns and timelines ensuring seamless execution, timely completion and handoff to drug product team.Manage the diligence process to select commercial DS CDMOs.Partner with stakeholders to facilitate execution of analytical and formulation development, characterization and stability studies.Serve as subject matter expert and enable successful tech transfer to commercial CDMOs.Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.Analyze and incorporate data from process and manufacturing runs in relevant regulatory filings.Apply QbD principles to develop process parameters and product quality relationships to aid process optimization in support of late-stage development.Partner with stakeholders to support timely approval and execution of batch records, in-process sampling plans, release and stability protocols, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.Coordinate, review and draft relevant sections of the regulatory filings (IND, IMPD) ensuring timely completion of relevant CMC sections.Perform CMC 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 the CDMOs and testing labs.Qualifications:
Master's or a PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent with 8-10 years of relevant experience working with monoclonal antibodies.Significant experience developing upstream and downstream processes in support of biologics manufacturing.Expertise in cell culture, media and bioreactor optimization with an emphasis on scale-up, scale-down models, process monitoring, facility fit and overall commercial readiness.Must have solid understanding of 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.Experience managing unit operations involving manufacturing of high concentration products ensuring product quality, stability and overall efficiencies.Must have direct experience or exposure to transition of processes from early stage to late stages such as process characterization, FMEA and PPQ campaigns.In depth knowledge of cGMP, ICH, WHO and FDA/EMA guidelines and experience utilizing them in a phase appropriate manner.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.Must have creative and strategic attitude with the ability to work in a fast-paced environment.Salary Range for the Role
$220,000-$225,000 USD
What We Offer:
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.Competitive salary and benefits package.A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.Opportunities for professional growth and development.
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.
Oruka Therapeutics is a newly launched company whose mission is to restore skin health. We were founded by well-known investors at Fairmount Funds, in the same model as Apogee Therapeutics and Spyre Therapeutics which together have raised $700M+ over the past two years and have made successful public debuts. We have a lead program that we expect will be in the clinic in 2025 and could offer transformative efficacy for a disease that affects millions of people.
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Position Overview:
We are seeking an experienced and motivated candidate to lead early-stage IND enabling drug substance (DS) process development and manufacturing activities. In this role, the ideal candidate will be responsible for overseeing cell line and process development, tech transfer, scale-up and DS manufacturing at the CDMOs. You will collaborate with groups like analytical, formulation and QC to assist method development, reference standard characterization, release and stability studies. The successful candidate will establish CMC strategy for early-stage process development, perform gap assessment, and provide timely solutions while continuing to plan late-stage development. In this role, you will oversee activities at the CDMO partners to track and ensure timely completion of GMP drug substance manufacturing. This role involves drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of the team with an opportunity to work in a fast-paced environment.
Key Responsibilities:Manage cell line development, clone selection/stability, upstream/downstream development and manufacturing operations at the CDMOs.Optimize upstream and downstream unit operations with an emphasis on robustness, scalability, quality, cost, validation and commercial plans.Lead drug substance manufacturing campaigns and timelines ensuring seamless execution, timely completion and handoff to drug product team.Manage the diligence process to select commercial DS CDMOs.Partner with stakeholders to facilitate execution of analytical and formulation development, characterization and stability studies.Serve as subject matter expert and enable successful tech transfer to commercial CDMOs.Serve as person-in-plant (PIP) during drug substance manufacturing campaigns.Analyze and incorporate data from process and manufacturing runs in relevant regulatory filings.Apply QbD principles to develop process parameters and product quality relationships to aid process optimization in support of late-stage development.Partner with stakeholders to support timely approval and execution of batch records, in-process sampling plans, release and stability protocols, review SOPs, change controls, deviations, OOS/OOT investigations, and CAPAs.Coordinate, review and draft relevant sections of the regulatory filings (IND, IMPD) ensuring timely completion of relevant CMC sections.Perform CMC 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 the CDMOs and testing labs.Qualifications:
Master's or a PhD degree in biochemistry, biochemical engineering, biotechnology or equivalent with 8-10 years of relevant experience working with monoclonal antibodies.Significant experience developing upstream and downstream processes in support of biologics manufacturing.Expertise in cell culture, media and bioreactor optimization with an emphasis on scale-up, scale-down models, process monitoring, facility fit and overall commercial readiness.Must have solid understanding of 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.Experience managing unit operations involving manufacturing of high concentration products ensuring product quality, stability and overall efficiencies.Must have direct experience or exposure to transition of processes from early stage to late stages such as process characterization, FMEA and PPQ campaigns.In depth knowledge of cGMP, ICH, WHO and FDA/EMA guidelines and experience utilizing them in a phase appropriate manner.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.Must have creative and strategic attitude with the ability to work in a fast-paced environment.Salary Range for the Role
$220,000-$225,000 USD
What We Offer:
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.Competitive salary and benefits package.A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.Opportunities for professional growth and development.
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.