Associate Director, Technical Operations (San Diego, CA or Remote) Job at Travere Therapeutics
Department:
106800 Technical Operations
Location:
San Diego, USA- Remote
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.
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients
.
Position Summary:
The Associate Director, Technical Operations is responsible for managing the upstream drug substance development, manufacturing, and scale up activities of a biologics product at the CDMOs, serving as a technical subject matter expert on upstream production (USP) 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 tech transfer, scale up, and manufacturing for the upstream drug substance production of biological products at 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, for upstream drug substance production.
- Verify suitability, qualification, and validation of upstream 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.
- Write USP technical reports on a variety of process development related subjects.
- Assist in preparation of CMC sections of regulatory submissions for USP.
Education/Experience Requirements:
- B.S. degree in Biochemistry, Chemistry, Chemical Engineering, or other related discipline. Equivalent combination of education and applicable job experience may be considered.
- 8 years of relevant experience including biologics manufacturing, scale-up, and late stage drug development.
Additional Skills/Experience:
- Manufacturing experience with upstream drug substance production of biologics; microbial fermentation is a plus.
- 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 10-20% domestically and internationally.
- positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
- Travere will require proof of vaccination status to perform onsite, face to face work or to become employed.
Travere Therapeutics, Inc. is an
EEO/AA/Veteran/Disability
Employer
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
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:
$132,000.00 - $182,000.00
- This information is current as of the initial date of this job posting and may be modified in the future. The actual pay determined for an individual will vary based on job-related factors such as location, relevant prior experience and/or education, particular skills and expertise.
COVID-19 VACCINATION REQUIREMENT
Where permitted, the Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment unless an exemption or accommodation is available and approved. Being fully vaccinated means that an individual is at least two weeks past their final dose of an authorized COVID-19 vaccine regimen and may include the individual obtaining vaccination boosters at certain intervals. Where permitted, as a condition of employment, final candidates will be required to provide proof of their COVID-19 vaccination unless an exemption or accommodation is available and approved. View the candidate COVID-19 vaccination policy webpage for information about the exemption or accommodation process for final candidates.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
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