Sr. Manager, Analytical Development Jobs in San Diego, CA at Emergent BioSolutions

Title: Sr. Manager, Analytical Development

Company: Emergent BioSolutions

Location: San Diego, CA

Salary: $200K – $250K*

Category: Pharmaceuticals & Biotech

Job Description

Position Summary

The candidate will provide scientific expertise and leadership for development of analytical methods to support all phases of vaccine product development. Candidate will be highly motivated and exercise a leadership role within the Analytical Development team. The candidate will have supervisory responsibilities to ensure the work is performed within timelines and to high quality standards. The candidate will be responsible for providing strategy, planning, development, and execution of assays to support CMC activities including process development, product characterization, and release and stability testing of early to late phase clinical vaccine drug products. In addition, the candidate will be expected to prepare scientific data presentations, write and review study reports, and laboratory protocols.

Essential Functions

Provide leadership and technical direction for development and execution of analytical methods for a variety of vaccine candidates.

Lead assay development and optimize characterization assays to determine protein physico-chemical properties, activity, identity, purity, and etc. in support of CMC development activities

Supervise activities of senior scientists and ensure accountabilities to department and project team objectives.

Provide technical strategies for identifying, evaluating and prioritizing the selection of appropriate technologies to implement analytical methods to support vaccine product development.

Lead assay optimization and technology transfer to external labs

Work closely with project leaders, project managers, and other functional groups (QA, Nonclinical, Regulatory, and Clinical Development) to provide scientific direction and oversight to ensure that project and team needs are met.

Serve as anad hocscientific resource to other groups and departments as well as the company’s project teams

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts

Minimum Education,Experience, Skills

PhD in Biochemistry, Virology, or Immunology with 10 plus years of related experience.

Wide knowledge of vaccine development and protein characterization methodologies.

Extensive knowledge of GMP and CMC regulatory guidance documents.

Hands-on experience with state-of the-art methods and instrumentation to support CMC supportive method development.

Excellent organization skills, supervisory experience, and excellent writing and presentation skills are required.

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Valid through: 6/5/2020


About Emergent BioSolutions

Emergent BioSolutions is a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland. It develops vaccines and antibody therapeutics for infectious diseases, oncology and autoimmune disorders, and provides medical devices for biodefense purposes. Among the companys notable products is BioThrax (Anthrax Vaccine Adsorbed), the only anthrax vaccine licensed by the U.S. Food and Drug Administration (FDA). The company also manufactures pharmaceuticals for adults and children with acute blood disorders, people undergoing certain liver transplants, palliative care for chemo or radiation therapy patients, hemophilia B and a varicella (Chickenpox) vaccine for high risk patients. The company has two divisions: a Biodefense division for medical countermeasures and a Biosciences division to treat infectious disease, autoimmune diseases, and cancer.