Janux Therapeutics
Senior Manager, Supply Chain
Janux Therapeutics, San Diego, California, United States, 92189
Reporting into Janux Therapeutics’ Director of Supply Chain, the Senior Manager, Supply Chain will be responsible for the strategic operational oversight of all aspects of clinical supply chain to ensure timely drug supply for Janux’s clinical programs. This role will collaborate with CMC, Clinical Operation, Regulatory and Quality Assurance team members to forecast and support clinical trial supply requirements including clinical drug manufacturing schedules and inventory; packaging, labeling and distribution activities.Essential Functions and Responsibilities:
Prepare and maintain demand forecasts, packaging, and distribution plans adapting strategies as required to ensure adequate supply to clinical sites and minimize product wastage.Assist in the selection and management of Contract Packaging organizations (CPO), contracts and inventories at depot sites.Provides technical and strategical oversight of packaging and labeling activities at CPOs and distribution to clinical sites.Collaborate with cross-functional departments to create and approve labeling designs in alignment with regulatory framework.Manage logistics for Master Cell Bank, Drug Substance, Drug Product shipment from CDMO to storage and CPOs.Develop and review Interactive Response Technologies (IRT) specifications and manage daily supply activities in IRT systems.Manage drug return, destruction process, and accountability at the depots.Collaborate with Quality Assurance team on Quality Events investigations, deviations/CAPA, Batch Record Review and drug disposition as required. Manage expiry date extensions, documentation, and distribution activities.Participate in forecast meetings with Clinical Operations including the preparation of slides and communication of inventory updates and operational strategies for all studies.Identify and lead process improvement initiatives.Other duties as deemed necessary.Required Skills and Qualifications
Technical degree or equivalent (BS / MS) in a scientific or pharmaceutical discipline.6+ years of biotechnology/pharmaceutical industry experience with 3+ years of experience in clinical supply chain management.Inventory management and vendor oversight experience in all phases of drug development for biologics with global clinical supply distribution is required.Solid understanding of the manufacturing of biologics is highly desirable.Demonstrated understanding of clinical research protocol requirements and experience developing IRT specifications.Experience with logistic systems and shipping required.Intermediate knowledge and understanding of cGMP, GCP regulations, and Annex 13.Effective communication and direction.Ability to identify project risks and rapidly develop and implement risk mitigation strategies in a fast-paced environment with changing priorities.$157,000 - $165,000 a year
Compensation:
In addition to a competitive base salary ranging from $157,000 to $165,000, we offer stock options, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.
Job Type:
Full-timeBenefits:·
401K·
Medical insurance·
Dental insurance·
Vision insurance·
Supplemental disability insurance plans·
Flexible schedule·
Life insurance·
Flexible vacation·
Sick time·
Incentive stock option plan·
Relocation assistanceSchedule:·
Monday to FridayWork authorization:·
United States (Required)Additional Compensation:·
Annual targeted bonus X%Work Location:·
On site (San Diego, CA)EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect theinterests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.
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Prepare and maintain demand forecasts, packaging, and distribution plans adapting strategies as required to ensure adequate supply to clinical sites and minimize product wastage.Assist in the selection and management of Contract Packaging organizations (CPO), contracts and inventories at depot sites.Provides technical and strategical oversight of packaging and labeling activities at CPOs and distribution to clinical sites.Collaborate with cross-functional departments to create and approve labeling designs in alignment with regulatory framework.Manage logistics for Master Cell Bank, Drug Substance, Drug Product shipment from CDMO to storage and CPOs.Develop and review Interactive Response Technologies (IRT) specifications and manage daily supply activities in IRT systems.Manage drug return, destruction process, and accountability at the depots.Collaborate with Quality Assurance team on Quality Events investigations, deviations/CAPA, Batch Record Review and drug disposition as required. Manage expiry date extensions, documentation, and distribution activities.Participate in forecast meetings with Clinical Operations including the preparation of slides and communication of inventory updates and operational strategies for all studies.Identify and lead process improvement initiatives.Other duties as deemed necessary.Required Skills and Qualifications
Technical degree or equivalent (BS / MS) in a scientific or pharmaceutical discipline.6+ years of biotechnology/pharmaceutical industry experience with 3+ years of experience in clinical supply chain management.Inventory management and vendor oversight experience in all phases of drug development for biologics with global clinical supply distribution is required.Solid understanding of the manufacturing of biologics is highly desirable.Demonstrated understanding of clinical research protocol requirements and experience developing IRT specifications.Experience with logistic systems and shipping required.Intermediate knowledge and understanding of cGMP, GCP regulations, and Annex 13.Effective communication and direction.Ability to identify project risks and rapidly develop and implement risk mitigation strategies in a fast-paced environment with changing priorities.$157,000 - $165,000 a year
Compensation:
In addition to a competitive base salary ranging from $157,000 to $165,000, we offer stock options, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.
Job Type:
Full-timeBenefits:·
401K·
Medical insurance·
Dental insurance·
Vision insurance·
Supplemental disability insurance plans·
Flexible schedule·
Life insurance·
Flexible vacation·
Sick time·
Incentive stock option plan·
Relocation assistanceSchedule:·
Monday to FridayWork authorization:·
United States (Required)Additional Compensation:·
Annual targeted bonus X%Work Location:·
On site (San Diego, CA)EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect theinterests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.
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