Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.
We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.
The Quality Assurance Specialist III Analytical is responsible for the review and approval of analytical quality documentation supporting commercial and clinical products including intermediates drug substances (APIs) and drug products manufactured and tested by Ardelyx contract manufacturing organizations (CMOs) and contract laboratories. The role supports quality oversight of laboratory investigations including Out-of-Specification (OOS) Out-of-Trend (OOT) and other atypical analytical results while ensuring compliance with applicable GMP regulations and internal procedures. The position also contributes to continuous improvement initiatives that enhance the effectiveness and compliance of Ardelyxs Quality System.
A strong background in small molecule analytical methodologies (e.g. wet chemistry HPLC/UPLC GC dissolution and other compendial techniques) is essential to support the review of in-process release validation and stability analytical documentation. The successful candidate will collaborate effectively with CMOs contract laboratories Regulatory Affairs Manufacturing Technical Operations and cross-functional stakeholders to support timely product disposition laboratory investigations and regulatory compliance.
This is a hybrid-based role working 2-3 days per week out of our Newark CA office
Responsibilities:
Review and approve analytical quality documentation supporting regulatory submissions (e.g. INDs NDAs amendments supplements and annual reports) ensuring compliance with applicable regulatory requirements
Review and approve batch-related analytical documentation and support product disposition for clinical registration commercial and stability batches
Evaluate completed analytical records (raw data laboratory notebooks reports CoAs CoTs and supporting documentation) to ensure accuracy completeness and compliance with GMP requirements
Review analytical methods method validation protocols and reports method transfers and associated change controls
Participate in the review of specifications specification justifications and specification revisions
Support Regulatory Affairs by reviewing manufacturing process analytical method and specification changes that may impact regulatory submissions
Review Quality System records including deviations (OOS OOT laboratory investigations) CAPAs change controls and risk assessments ensuring timely completion and compliance
Review and approve stability protocols reports and stability data in accordance with internal procedures and applicable regulatory requirements
Review stability data generated internally or externally including trend evaluation
Collaborate with CMOs contract laboratories Manufacturing Analytical Development and Technical Operations to resolve quality-related issues
Participate in continuous improvement initiatives to enhance analytical quality processes and quality system effectiveness
Qualifications:
Bachelors degree in Chemistry Pharmaceutical Sciences Biology or a related field with 5 years of experience in analytical development manufacturing or quality assurance within the biotechnology industry or equivalent experience
Experience working with CMOs and contract laboratories preferred
Experience using electronic Quality Management Systems (e.g. Veeva Vault TrackWise) preferred
Experience reviewing analytical methods method validation method transfer change controls and stability documentation
Working knowledge of applicable GMP regulations and guidance including FDA ICH USP/NF and other pharmacopeial standards
Experience with drug substance and drug product analytical testing including troubleshooting and problem-solving
Strong written and verbal communication skills with internal and external stakeholders
Effective organizational planning and time-management skills
Ability to manage multiple priorities in a fast-paced environment
Demonstrated attention to detail and sound decision-making skills
Proficiency with Microsoft 365 applications SharePoint and Veeva
The anticipated annualized base pay range for this full-time position is $105000-$129000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision)life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Required Experience:
IC
DescriptionArdelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.Team Arde...
Description
Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.
We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.
The Quality Assurance Specialist III Analytical is responsible for the review and approval of analytical quality documentation supporting commercial and clinical products including intermediates drug substances (APIs) and drug products manufactured and tested by Ardelyx contract manufacturing organizations (CMOs) and contract laboratories. The role supports quality oversight of laboratory investigations including Out-of-Specification (OOS) Out-of-Trend (OOT) and other atypical analytical results while ensuring compliance with applicable GMP regulations and internal procedures. The position also contributes to continuous improvement initiatives that enhance the effectiveness and compliance of Ardelyxs Quality System.
A strong background in small molecule analytical methodologies (e.g. wet chemistry HPLC/UPLC GC dissolution and other compendial techniques) is essential to support the review of in-process release validation and stability analytical documentation. The successful candidate will collaborate effectively with CMOs contract laboratories Regulatory Affairs Manufacturing Technical Operations and cross-functional stakeholders to support timely product disposition laboratory investigations and regulatory compliance.
This is a hybrid-based role working 2-3 days per week out of our Newark CA office
Responsibilities:
Review and approve analytical quality documentation supporting regulatory submissions (e.g. INDs NDAs amendments supplements and annual reports) ensuring compliance with applicable regulatory requirements
Review and approve batch-related analytical documentation and support product disposition for clinical registration commercial and stability batches
Evaluate completed analytical records (raw data laboratory notebooks reports CoAs CoTs and supporting documentation) to ensure accuracy completeness and compliance with GMP requirements
Review analytical methods method validation protocols and reports method transfers and associated change controls
Participate in the review of specifications specification justifications and specification revisions
Support Regulatory Affairs by reviewing manufacturing process analytical method and specification changes that may impact regulatory submissions
Review Quality System records including deviations (OOS OOT laboratory investigations) CAPAs change controls and risk assessments ensuring timely completion and compliance
Review and approve stability protocols reports and stability data in accordance with internal procedures and applicable regulatory requirements
Review stability data generated internally or externally including trend evaluation
Collaborate with CMOs contract laboratories Manufacturing Analytical Development and Technical Operations to resolve quality-related issues
Participate in continuous improvement initiatives to enhance analytical quality processes and quality system effectiveness
Qualifications:
Bachelors degree in Chemistry Pharmaceutical Sciences Biology or a related field with 5 years of experience in analytical development manufacturing or quality assurance within the biotechnology industry or equivalent experience
Experience working with CMOs and contract laboratories preferred
Experience using electronic Quality Management Systems (e.g. Veeva Vault TrackWise) preferred
Experience reviewing analytical methods method validation method transfer change controls and stability documentation
Working knowledge of applicable GMP regulations and guidance including FDA ICH USP/NF and other pharmacopeial standards
Experience with drug substance and drug product analytical testing including troubleshooting and problem-solving
Strong written and verbal communication skills with internal and external stakeholders
Effective organizational planning and time-management skills
Ability to manage multiple priorities in a fast-paced environment
Demonstrated attention to detail and sound decision-making skills
Proficiency with Microsoft 365 applications SharePoint and Veeva
The anticipated annualized base pay range for this full-time position is $105000-$129000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision)life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.
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