Senior Manager, Product Development

Location
San Diego, CA, US
Posted
Feb 15, 2021
Ref
699976200
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.

Position Summary

The Sr. Manager, Product Development will report to the Senior Director of Product Development, and independently manage and mentor a team of Scientists/Senior Scientists. The applicant will have strong leadership skills and is responsible for working with the team to meet Company timelines and objectives.

To be successful in this role, the applicant must demonstrate the leadership, experience, and scientific skills to drive team performance and meet challenging goals.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions .
  • Support development of phase appropriate clinical pharmaceutical products.
  • Develop and execute plans and schedules with the appropriate level of detail to achieve Product Development objectives.
  • Manage Scientist/Senior Scientist by creating a culture of efficient execution and continuous improvement in which individuals and teams can excel.
  • Align with Analytical, Production, Regulatory, and Quality teams, to ensure that CMC project objectives are achieved.
  • Oversee the implementation and/or technology transfer of drug substance and drug product processes and process improvements into CMOs.


Minimum Education, Experience and Skills
  • PhD or Masters in Biology, Molecular Biology, Biochemistry, or Pharmaceutical Science related degree
  • Minimum 8 years pharmaceutical environment in progressively responsible roles.
  • Experienced team leader, including managing direct reports
  • Formulation and Fill/Finish experience
  • Knowledgeable of upstream/downstream process development
  • Biophysical characterization/analytic experience
  • Strong molecular biology background (immunoassay, PCR/RT-PCR, API characterization, development/troubleshooting, etc.)
  • Solid understanding of US and European regulations including application in a
  • laboratory environment
  • Previous experience working with FDA and participating in regulatory agency inspections is desired.
  • Ability to successfully solve challenging issues, critical thinking and detail oriented
  • Strong interpersonal, verbal and written communication skills
  • Ability to work well in a fast-paced, team-oriented environment
  • Excellent organizational ability - can easily multi-task and shift priorities as needed
  • Works independently
  • Must have good written and verbal communication skills.
  • Ability to tailor communications to all levels in the organization and prepare appropriate updates to functional groups
  • Proficiency in MS Office products are required


There are physical/me ntal 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 function s.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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.

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