Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells. Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options.
Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy!
What we look for At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We are relentless in our focus to offer new hope to families facing devastating diagnoses. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face. We are building an exciting and fast-paced company passionate about discovering and developing tomorrow's most innovative cancer therapies.
Abdera is seeking a Director of Good Manufacturing Practice (GMP) Quality Assurance who will be responsible for the oversight of the disposition of drug substance and final drug product manufactured by the external contract manufacturing organizations. This position demands a proactive approach, attention to detail, and a commitment to maintaining the highest standards of quality and compliance in clinical manufacturing processes.
Salary Range: US$ 190 - 230K Principal Responsibilities Work cross-functionally with CMC team to provide Quality oversight of GMP activities that occur at contract manufacturers.Be accountable for the GMP activities at multiple contracted locations, through a combination of person in plant and remote collaboration activities.Ensure appropriate Quality oversight by demonstrating a technical understanding of the relevant production processes used, including chemical synthesis, biologics production through cell culture and purification, and drug product production through radio labeling.Provide expertise in the interpretation of regulations and guidance relating to product development from a quality perspective.Represent QA on project teams and with contract manufacturers as required. Direct all aspects of quality support and strategy for the project team for designated site(s).Actively monitor ongoing contractor-related manufacturing, quality control testing, and other activities. Provide feedback to stakeholders in a timely manner as per established Quality Agreements.Review and approve partner/contractor GMP documentation, including but not limited to validation protocols/reports (e.g., process, method, etc.), analytical test methods, and stability protocols/reports, batch records and operating procedures.Accountable for the lot disposition of clinical drug substance/API and drug product which includes but not limited to reviewing master and executed batch records, product specifications, certificates of analysis, analytical test data (in-process and release).Ensure the tracking, investigation, and timely resolution of deviations/investigations, OOT, OOS, product complaints and temperature excursions.Establish and react to Quality metrics identifying gaps, trends, and opportunities for process improvements.Qualifications, Education & Experience Bachelor's degree in life science, engineering, or equivalent.Minimum of ten (10) years of Quality Assurance experience in FDA regulated industry, preferably, biologic or Antibody Drug Conjugate therapeutics.Prior experience working with contract manufacturing organizations required.Prior lot disposition experience required.Competence in FDA and international GMP requirements.Excellent verbal and written communication skills; ability to lead Quality function as part of multi-faceted projects.Excellent interpersonal and collaboration skills.Ability to operate in a fast-paced, multi-disciplinary industrial environment.Skills & Abilities Problem-solving and solution-oriented mindset.Strong leadership and project management skills with the ability and willingness to effectively build and manage a small team. Experience in people management and development.At ease in start-up environment and effectively deliver in fast-paced, dynamic and flexible-structured environments.Approximately up to 40% of travel.Abdera is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.
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