Sr. Manager, Analytical Development

Location
San Diego, CA, US
Posted
Apr 08, 2020
Ref
644493600
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life .

JOB 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

Reasonable accommodations will be made to enable individuals with disabilities to perform the 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 an ad hoc scientific 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 managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

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.

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.