- Accountable for master batch records reviews, conduct and/or oversee in-process and final product lot release partnering with multiple CMOs through audits, and batch record and testing approvals.
- Responsible for the implementation and management of electronic Quality Management system (eQMS). Assist with the development, review and approval of quality system including Standard Operating Procedures (SOPs) required for molecularly targeted radiotherapy product manufacturing, packaging, and distribution.
- Manages and oversees change controls, deviations/investigations, CAPAs, vendor qualification, customer complaints, stability studies, regulatory agency inspections, product recalls, and annual product review.
- Supports Quality Management Review on the performance of the quality system, including periodic management reports, management review meetings, and other reviews and recommendations for system improvements.
- Perform and/oversee the completion of internal audits. Coordinate, support and facilitate third party regulatory audits/assessments.
- Minimum of a Bachelor's degree in life science or equivalent and 8+ years' experience in GXP and Quality Systems in biotechnology, antibody drug conjugated or molecularly targeted radio therapies.
- Demonstrated in-depth experience of establishing, refining, and operating Quality Assurance related systems for clinical manufacturing in the Biotechnology industry.
- In depth knowledge of regulations and guidance supporting phase appropriate cGMP to include FDA, EMA, ISO standards and ICH guidelines with direct impact to clinical programs.
- Experience reviewing and collaborating on regulatory submissions as well as hosting inspections/interactions.
- Experience working effectively with CMOs
- A solid understanding of GMPs and CMC requirements is expected.
- Strong knowledge of Quality, Compliance, US & International cGxPs, regulations, product development and manufacturing.
- Must be familiar with ICH regulations and FDA/EMA requirements and expectations, plus experience with health authority inspections.
- Demonstrated thought leadership in CMC Quality Assurance.
- Experience in preparing regulatory filings.
- Strong interpersonal and collaboration skills.
- Excellent verbal and written communication skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment.
- Ability to critically evaluate and troubleshoot complex problems and attention to detail.
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Senior Manager, CMC Quality Assurance - Menlo Park, United States - Abdera Therapeutics
Description
Who we areAbdera 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 Senior Manager, CMC Quality Assurance, to help lead quality for Abdera's novel oncology therapies. The Senior Manager of CMC Quality Assurance will be responsible for building the CMC quality assurance processes and providing Quality oversight for the GMP activities throughout the development stages of antibody-based radiopharmaceuticals.
Salary Range: US$ 145K - $180K
Principal Responsibilities
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.
