Travere Therapeutics
Director, Technical Operations (Biologics, Drug Substance)
Travere Therapeutics, San Diego, California, United States, 92189
Department:106800 Technical Operations
Location:San Diego
Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
The Director, Technical Operations is responsible for managing the drug substance and drug product development, manufacturing, scale up, and validation activities of a biologics product at the CDMOs, serving as a technical subject matter expert for Travere. This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory, supporting the corporate goals for clinical development to commercialization of a biologics drug product for a rare disease indication.
Responsibilities:
Technical oversight of the manufacturing and scale up of a biological product at Travere’s CDMOs.
Review and approve pre-BLA studies, such as process characterization protocols and reports, in collaboration with Travere’s CDMOs.
Provide technical review and approval for manufacturing related documents including change notifications, batch records, process development, tech transfer, and validation protocols/reports.
Verify suitability, qualification, and validation of processes at CDMOs and other external laboratories.
Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
Provide CMC development and manufacturing support on internal and external project teams.
Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production.
Author and review CMC sections of regulatory submissions.
Write technical reports on a variety of process development related subjects.
Education/Experience Requirements:
M.S. in Biochemistry, Chemistry, Chemical Engineering, or other related discipline. Ph.D. degree highly preferred. Equivalent combination of education and applicable job experience may be considered.
Minimum 8+ years of relevant experience including biologics manufacturing, scale-up, and late-stage drug development and commercialization.
Additional Skills/Experience:
Expertise in biologics production and aseptic fill/finish, including lyophilization, is necessary.
Manufacturing experience with microbial production and PEGylation is a plus.
Experience in managing late phase / commercial programs.
Expert knowledge in process development, QbD, validation and technology transfer procedures.
Strong professional experience in a similar role within the pharmaceutical industry, preferably in biologics development.
Broad knowledge and experience within the GMP environment and regulatory affairs.
Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.
Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
Excellent decision-making and collaboration skills with strong attention to detail.
Six Sigma and statistical knowledge is a plus.
Ability to travel 20%-25% domestically and internationally.
Total Rewards Offerings:Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits:Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Compensation:Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:$175,000.00 - $235,000.00
This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
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Location:San Diego
Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
The Director, Technical Operations is responsible for managing the drug substance and drug product development, manufacturing, scale up, and validation activities of a biologics product at the CDMOs, serving as a technical subject matter expert for Travere. This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory, supporting the corporate goals for clinical development to commercialization of a biologics drug product for a rare disease indication.
Responsibilities:
Technical oversight of the manufacturing and scale up of a biological product at Travere’s CDMOs.
Review and approve pre-BLA studies, such as process characterization protocols and reports, in collaboration with Travere’s CDMOs.
Provide technical review and approval for manufacturing related documents including change notifications, batch records, process development, tech transfer, and validation protocols/reports.
Verify suitability, qualification, and validation of processes at CDMOs and other external laboratories.
Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
Provide CMC development and manufacturing support on internal and external project teams.
Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production.
Author and review CMC sections of regulatory submissions.
Write technical reports on a variety of process development related subjects.
Education/Experience Requirements:
M.S. in Biochemistry, Chemistry, Chemical Engineering, or other related discipline. Ph.D. degree highly preferred. Equivalent combination of education and applicable job experience may be considered.
Minimum 8+ years of relevant experience including biologics manufacturing, scale-up, and late-stage drug development and commercialization.
Additional Skills/Experience:
Expertise in biologics production and aseptic fill/finish, including lyophilization, is necessary.
Manufacturing experience with microbial production and PEGylation is a plus.
Experience in managing late phase / commercial programs.
Expert knowledge in process development, QbD, validation and technology transfer procedures.
Strong professional experience in a similar role within the pharmaceutical industry, preferably in biologics development.
Broad knowledge and experience within the GMP environment and regulatory affairs.
Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies.
Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
Excellent decision-making and collaboration skills with strong attention to detail.
Six Sigma and statistical knowledge is a plus.
Ability to travel 20%-25% domestically and internationally.
Total Rewards Offerings:Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits:Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.
Compensation:Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:$175,000.00 - $235,000.00
This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.
Travere will accept applications on an ongoing basis until a candidate is selected for the position.
If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.
#J-18808-Ljbffr