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Please Note - Candidate will be required to be onsite. Responsibilities - Writing and review of protocols and/or reports for manufacturing process characterization studies - Writing of protocols/batch records for manufacturing process validation - Writing and/or review of other CMC documents as needed - All activities will need to be performed in close collaboration with key team members Skills/Experience: - Excellent technical writing and reviewing skills for process development and ...

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 ...

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 ...

2013…..NOW HIRING….GMP QA Associate…..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 seeking an Associate Director, Analytical Sciences to join its’ dynamic team. The successful candidate will assure cGMP compliance with applicable regulatory requirements including audits and ...

- The Manufacturing associate will be responsible for supporting manufacturing operations by working as an operator in all aspects of plasmid DNA manufacturing, including fermentation, lysis, and chromatographic processes and applying knowledge to troubleshoot problems as well as improve manufacturing procedures. - The Manufacturing Associate will work to execute and troubleshoot equipment during Manufacturing runs. - In addition, the Manufacturing Associate will assist the Facilities department ...

Our client assists customers in rapidly developing, manufacturing and commercializing point of care lateral flow, flow through and ELISA assays for any market segment. Our client develops products for markets as broad as clinical diagnostics, veterinary diagnostics, food science, and microbiology and operates under design controls and GMP as required. They are seeking a Research Associate who will be responsible for research and development of products from feasibility through clinical trials and ...

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 ...

DUTIES: - Support the Manufacturing department by working effectively to meet department goals, objectives and tasks to achieve desired results. - Responsible for completing assigned tasks which include cleaning, sterilizing, and prepping glassware and parts used in the manufacturing environment. - Work with senior technicians and leads to prioritize tasks and assignments and make recommendations to maximize efficiency and productivity based on shift needs. - May also include ...

In this position, you will need to work effectively as part of a team responsible for ensuring successful and efficient cell culture/fermentation processes for the production of marketed recombinant proteins. This group provides ongoing technical and scientific support and oversight for the unit operations utilized in the manufacture of these marketed products. Additionally, the group conducts laboratory experiments and full-scale studies to continually improve and optimize process performance. Note: ...

Essential Duties & Responsibilities: - Candidates must be able to work during normal business hours 8am-5:00pm. - The Administrative Assistant will lend support to the Research and Development and Manufacturing Departments and will report directly to the COO. Summary of Job functions: - Maintains records, prepares reports, and composes correspondence relative to the work. - Reviews, analyzes, records and resolves customer complaints about quality control issues. Responds to and makes ...

The major responsibility for the QA Associate is to monitor the work performed by manufacturing personnel in the custom mix area to ensure that information found in the formula are correct. The position may also involve review of other documentation, verification of work processes in accordance with SOPs and directions of the QA Manager. Other tasks include assistance with batch record review and documentation, such as training records. Aseptic processing knowledge and/or experience is a plus. The ...

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 ...

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 ...

Seeking 3+ years experience developing and manufacturing microparticles as well as characterizing nanoparticles and magnetic materials using spectroscopy, electron microscopy and dynamic light scattering to support a scientific team developing of an in-vitro diagnostic systems and clinical cancer diagnostics. Opportunity to work with award winning team and gain expertise in the latest antibody cojugated technologies for diagnostic and therapeutic applications. Salary commensurate with potential ...

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 ...

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 ...

This position reports to the Executive Director of Manufacturing and is responsible for developing and implementing the company’s production planning functions including projects planning/coordination, master production scheduling, material requirements, planning systems, work-in-progress tracking, and manufacturing performance reporting. Responsibilities include but are not limited to: •Create manufacturing schedules and associated resource lists to ensure sufficient materials, staffing, and ...

Position Description: Our client, a leading alternative energy researcher, is seeking a QC Analyst to be responsible for conducting quality control routine and non-routine analysis of raw materials, in process, and finished formulation enzyme products according to standard operating procedures. Job scope includes performing new method development, method improvements and validation of enzyme activity determination or supporting assays. Critical Competencies: • Conducts microbiological and ...

Description: The successful candidate will determine best formulations and protocol parameters for a novel DNA isolation kit. The manager will oversee process validation/optimization activities, contractor manufacturing scale-up and technology transfer to a few beta test labs. Must have experience working in R&D at early stage development of new products to ensure requirements for tech transfer are addressed. Familiarity with automation, UHTS requirements and enzyme stability is desired. Experience ...