
Quality is critical in the manufacturing of drug products. Allermed is seeking an individual to provide Quality Assurance oversight of the Analytical Quality Control Laboratory and Quality Assurance function for the manufacture of licensed biologic products. The position reports to the Chief Operating Officer. The major responsibility for this position is two-fold. 1. Oversight of the Quality Control laboratory requires an individual who has had analytical laboratory experience and feels ...
May 24 - San Diego

2013…..NOW HIRING in San Diego….QA Manager Validation…..Ardea Biosciences/Astra Zeneca Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. Ardea is searching for a QA Manager, Validation to join the team. The successful candidate will assure software validation compliance with applicable regulatory requirements including ...
May 22 - San Diego

Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases We are seeking a medical writer who will be responsible for writing and/or revising regulatory documents in support of drug development, including clinical protocols, clinical study reports, patient narratives and investigator brochures. Responsibilities include: •Write and/or ...
May 22 - San Diego

2013…..NOW HIRING in San Diego….Director/Sr. Director, Regulatory & Scientific Communications…..Ardea Biosciences/Astra Zeneca Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. The successful candidate will be responsible for managing and directing the medical writing function as well as producing documents for regulatory ...
May 20 - San Diego

We are a small biopharmaceutical company located in Sorrento Valley. Our exciting product is entering into a new late phase of clinical trials. We are looking for a hands-on Quality Assurance CMC Sr. Manager/ Director to lead the strategy for CMC (chemistry, manufacturing and controls) activities leading to submission and approval of product marketing applications. The incumbent will assist in planning, reviewing, and preparing CMC documentation in CTD format to support clinical development and ...
May 15 - San Diego

The Surgical Regulatory Affairs Manager handles all regulatory development aspects for surgical devices as assigned. These include IOLs, Inserters and Solutions. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities. ...
May 8 - San Diego

Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. Ardea Biosciences is searching for a Regulatory CMC Manager/Associate Director to join the team. The Regulatory CMC Manager/Associate Director leads the regulatory strategy for, and execution of, global CMC (chemistry, manufacturing and controls) activities leading to ...
May 6 - San Diego

Allied Search Partners is looking for a qualified Molecular Genetic Technologist (Licensed CLS) candidate for a state of the art facility in the Oceanside, CA area. This position is full time permanent. Know someone for this position? We offer a $$ bonus if we place your referral in a position. For a complete list of current Allied Search Partners openings Nationwide please go to: http://www.alliedsearchpartners.com/careers.php Position: Molecular Technologist (Must be a licensed CLS) Schedule: ...
May 6 - Oceanside

We are a small biopharmaceutical company located in Sorrento Valley. Our exciting product is entering into a new late phase of clinical trials. We are looking for a hands-on CMC Project Manager to oversee internal CMC team in collaboration with the project team leader, integration of project deliverables/ activities and proactive communication with stakeholders. Facilitates the creation and maintenance of clear, concise Integrated CMC Plan consistent with guidance documents and drives the ...
Apr 18 - San Diego

AltheaDx performs assay development and clinical testing services for biopharma customers and physicians. Our biopharma service menu covers early stage biomarker discovery through companion diagnostics development, clinical trials and regulatory submission to FDA. AltheaDx is bringing theranostics into clinical use. Please visit our website http://www.altheadx.com for additional details. Clinical Lab Scientist (CLS) The successful candidate will be responsible for performing assay validation, CLIA ...
Apr 16 - San Diego

Ardea Biosciences/Astra Zeneca…NOW HIRING in San Diego... Senior Project Manager Ardea Biosciences, Inc. a wholly owned subsidiary of Astra Zeneca based in San Diego is a Biotechnology Company focused on the development of small molecule therapeutics for the treatment of serious diseases. Ardea Biosciences is searching for a Senior Project Manager to join the team. The overall responsibility will be to apply project management and leadership skills to programs through all stages of the candidate ...
Apr 16 - San Diego

Leading diagnostic organization seeks Staff Scientist to design, develop, and validate novel molecular assays for laboratory testing. Hands on experience with the following required: *** Quantitative gene expression assays and assay platforms *** DNA array based molecular assay development *** Process development and optimization *** Verification and validation studies *** CLIA approved tests MS or PhD in a scientific field required. Well established company with documented history of ...
Apr 11 - San Diego

Responsible for providing comprehensive Records Management and Documentation support and guidance to departments requiring Records Storage and/or QA Controlled Documentation support. Ensures that Oceanside documentation consistently meets our customer and regulatory requirements. Job Responsibilities: - Responsible for performing, monitoring and maintaining tasks and responsibilities for Oceanside Records Management and serve as single point of contact. - Monitor QA Documentation Vaults in ...
Apr 3 - Oceanside

Our client is a leading formulator and manufacturer of customized nutritional supplements. The Company's comprehensive partnership approach to client servicing is unique within the industry, combining clinical research, science-based formulation, advanced quality assurance testing methodologies, superior manufacturing and packaging capabilities and broad marketing experience to create nutritional products that are formulated to address specific health conditions. Summary Primarily responsible for ...
Apr 3 - San Diego

Our client is a privately held biopharmaceutical company focused on the research, development and commercialization of molecular transport agents. They are seeking a Manufacturing Technician II to join their team. This is a Contract to HIRE role and is accompanied by a competitive compensation package. Description of Duties: • Performs cGMP manufacturing of R&D, Pre-Clinical, and Clinical products. • Assembles, operates, cleans, and maintains production equipment. • Weighs, measures and checks ...
Mar 29 - San Diego

Our client is looking for a skilled QA Product Support Specialist to perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures. Assists in investigations where requested. Performs other duties to support ...
Mar 29 - Carlsbad