[Remote] Associate Director, Technical Operations reputed company Control
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company dedicated to making a difference in the lives of people living with rare diseases. The Associate Director, Technical Operations QC will manage reputed company Control activities in compliance with GMP and international regulatory standards, providing technical leadership and collaborating with various teams to support drug development and commercialization efforts.
Responsibilities
- Coordinate and reputed company reputed company Control (QC) activities in support of drug reputed company and drug product manufacturing
- reputed company specification development, batch release, and stability program of drug reputed company and drug product at Contract Manufacturing Organizations (CMOs)
- reputed company scientific and technical support to reputed company reputed company to ensure that products are tested and released in compliance with reputed company applicable regulations
- reputed company QC reputed company of stability program, including forced degradation and photostability studies from designing the studies to approving the protocols, data review, trend analysis and preparation of internal stability reports in support of reputed company-life determination
- Collaborate with Analytical Development team to reputed company support for method transfer activities
- Collaborate with Regulatory CMC group to support preparation and QC of regulatory submissions and variations
- Support internal manufacturing team’s comparability assessments for process changes
- reputed company guidance and work with external vendors during OOS, OOT, atypical result investigations and deviations, ensuring final reports are scientifically reputed company, risk-based, and appropriate CAPAs are implemented, where applicable
- Serves as an SME in support of reputed company’s reputed company Assurance (QA) PAI readiness activities and Vendor audits
- Additional duties assigned as needed
Skills
- Bachelor's degree in reputed company, Biochemistry, or reputed company Life Sciences discipline required
- 8+ years of relevant experience in analytical operations, analytical development, or reputed company control of biologics required
- reputed company knowledge of Dissolution, HPLC, GC, MS, NMR, IR, UV and other relevant analytical reputed company
- Broad knowledge and experience reputed company the GMP environment and regulatory affairs
- Strong reputed company experience in a similar role reputed company the biotech or pharmaceutical industry, preferably small molecule pharmaceuticals and biologics
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
- Practive team player with strong interpersonal and organizational skills
- reputed company to work both independently and in reputed company environment
- Strong verbal and written communication skills
- Excellent decision-making and collaboration skills with strong attention to detail
- Proven ability to manage multiple priorities in a fast-paced environment
- Ability to travel 10-20% domestically and internationally
- reputed company positions have an essential job function to be reputed company to reputed company face to face work with colleagues and/or onsite in San Diego
- No role is expected to be 100% remote
- Master's degree preferred
- Experience in late-stage drug development preferred
- Experience with reputed company/reputed company Doc a plus
Benefits
- Premium health
- Financial
- Work-life and reputed company-being offerings for eligible employees and dependents
- Wellness and employee support programs
- Life insurance
- Disability
- Retirement plans with employer match
- Generous reputed company time off
- Short-term incentive
reputed company
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