Orukatx
Associate Director, Analytical Development, Tech Ops (Biologics) New Remote; Wal
Orukatx, Waltham, Massachusetts, United States, 02254
Associate Director, Analytical Development, Tech Ops (Biologics)
Remote; Waltham, Massachusetts, United States About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. As we build our core team, we're seeking top talent in different functional areas who are passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title:
Associate Director, Analytical Development, Tech Ops (Biologics) Location:
Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Open to remote. Role Overview: We are seeking an experienced and motivated Associate Director, Analytical Development, Tech Ops (Biologics) to lead the analytical function within the CMC team, in support of early-to-late-stage clinical trials. You are an ideal candidate for this role if you enjoy developing, optimizing, and trending performance for various analytical assays in support of release and stability testing of biologics. Key Responsibilities: Lead external method development, optimization, and qualification/validation efforts across liquid chromatography, capillary electrophoresis, spectrophotometric, and bioassay for release and stability testing of clinical trial materials Manage multiple non-GMP and GMP stability studies for drug substance (DS) and drug product (DP) batches for multiple programs Leverage stability data to project shelf-life of both DS and DP supply through trending analysis Develop strategies to establish characterization and comparability packages across various DS/DP lots Support process and manufacturing teams towards implementation of relevant analytical methods Work closely with cross-functional stakeholders (QA, Regulatory, Clinical Supply Chain) for shelf-life extension of clinical material to support ongoing clinical trials Partner with internal and external stakeholders to justify and establish DS/DP protocols and specifications Work with CDMO partners to perform root cause analysis and investigations to support OOS/OOT results that may arise during stability studies Contribute to IND/BLA sections pertaining to analytical methods, stability studies, characterization, and analytical comparability Lead the diligence process to select clinical and commercial CDMO vendors Partner with operations, legal, and finance groups to finalize confidentiality, master service, and contractual agreements 20-25% travel in support of diligence and campaign execution at the CDMOs Qualifications: Associate Director: Master’s (10+ years) or a PhD (6+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC. Experience with monoclonal antibodies is a requirement. Relevant industry experience in method development, qualification, validation, and method transfer in support of ongoing development and/or commercialization of biologics. Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based) Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada, EU, etc. Experience managing multiple stability studies, protocol development, and performing trending analysis, OOS/OOT investigations, root cause analysis, etc. Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch. 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 a creative and strategic attitude with the ability to work in a fast-paced 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. 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. Oruka Therapeutics is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive workplace and encourage applications from all qualified candidates, including women, minorities, and individuals with disabilities.
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Remote; Waltham, Massachusetts, United States About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. As we build our core team, we're seeking top talent in different functional areas who are passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title:
Associate Director, Analytical Development, Tech Ops (Biologics) Location:
Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week. Open to remote. Role Overview: We are seeking an experienced and motivated Associate Director, Analytical Development, Tech Ops (Biologics) to lead the analytical function within the CMC team, in support of early-to-late-stage clinical trials. You are an ideal candidate for this role if you enjoy developing, optimizing, and trending performance for various analytical assays in support of release and stability testing of biologics. Key Responsibilities: Lead external method development, optimization, and qualification/validation efforts across liquid chromatography, capillary electrophoresis, spectrophotometric, and bioassay for release and stability testing of clinical trial materials Manage multiple non-GMP and GMP stability studies for drug substance (DS) and drug product (DP) batches for multiple programs Leverage stability data to project shelf-life of both DS and DP supply through trending analysis Develop strategies to establish characterization and comparability packages across various DS/DP lots Support process and manufacturing teams towards implementation of relevant analytical methods Work closely with cross-functional stakeholders (QA, Regulatory, Clinical Supply Chain) for shelf-life extension of clinical material to support ongoing clinical trials Partner with internal and external stakeholders to justify and establish DS/DP protocols and specifications Work with CDMO partners to perform root cause analysis and investigations to support OOS/OOT results that may arise during stability studies Contribute to IND/BLA sections pertaining to analytical methods, stability studies, characterization, and analytical comparability Lead the diligence process to select clinical and commercial CDMO vendors Partner with operations, legal, and finance groups to finalize confidentiality, master service, and contractual agreements 20-25% travel in support of diligence and campaign execution at the CDMOs Qualifications: Associate Director: Master’s (10+ years) or a PhD (6+ years) with experience in a scientific discipline with relevant experience in analytical development and/or QC. Experience with monoclonal antibodies is a requirement. Relevant industry experience in method development, qualification, validation, and method transfer in support of ongoing development and/or commercialization of biologics. Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometer, Bioassay (ELISA and Cell-Based) Deep understanding of ICH guidelines for method development/qualification and validation as well as regulatory expectations in US, Canada, EU, etc. Experience managing multiple stability studies, protocol development, and performing trending analysis, OOS/OOT investigations, root cause analysis, etc. Experience in authoring/contributing to regulatory filings, specifically Module 3 for analytical methods and stability studies Demonstrated track record of successful tech transfers between CDMOs with an eye towards late-stage development and commercial launch. 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 a creative and strategic attitude with the ability to work in a fast-paced 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. 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. Oruka Therapeutics is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive workplace and encourage applications from all qualified candidates, including women, minorities, and individuals with disabilities.
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