Senior Director, PDP
Company: Emergent BioSolutions Inc
Location: San Diego
Posted on: April 9, 2021
By clicking the Accept button, you agree to us doing so.
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. Director, Process
Development and Production (PDP) will be responsible for process
development, clinical trial material production, and technology
transfer to the commercial manufacturing site. This position will
be involved in Emergent's various viral, virus-like-particle (VLP)
and nanoparticle vaccine development programs, which includes cell
culture, viral amplification/VLP transient transfection,
chromatography purification and diafiltration/ultrafiltration
processes. This position will manage several teams: upstream
process development, downstream process development, manufacturing
engineering, cell line development, assay development and clinical
production teams to efficiently complete the vaccine process
development and clinical production work. Additionally, this role
will support IND and BLA CMC sections and all internal and external
audits. Essential Functions Reasonable accommodations will be made
to enable individuals with disabilities to perform the essential
- Successfully manage and direct the activities of the Process
Development & Production group.
- Provide leadership and technical expertise in support of
vaccine development and clinical production.
- Mentor and support the professional development of team
- Lead cross-functional teams and coordinate with Analytical
Development, Product Development, Quality Assurance and Project
Management teams, in an effort to complete the development and
clinical production work efficiently.
- Responsible for PDP planning, and multi-year resource
- Lead cGMP activities (facilities, personnel, equipment,
processes, and procedures) compliant and efficient.
- Write and review investigational new drug (IND) and BLA CMC
- Evaluate and manage CMO/vendor activities.
- Support internal and external audits.
- Support FDA and EMA agency related meetings. Minimum Education,
Experience and Skills
- Minimum of 15 years' relevant industry experience with an M.S
degree or 10 years' experience with a Ph.D. degree.
- Master or Ph.D. of Science/engineering in Biology, chemistry,
chemical engineering, or related discipline is preferred
- Understanding of mammalian cell culture and downstream
purification process development and scale up is a must.
- cGMP experience is required.
- Experience in vaccine research, development and clinical
production is required.
- Experience of IND and BLA CMC section writing is
- Experience of FDA and EMA meeting and communication is
- Experience with live virus and virus-like-particles is
- Exceptional leadership skills and proven ability to interact
effectively with all levels of organization.
- Excellent management and communication skills. 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
-- 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
-- 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. ABOUT EMERGENT Protecting and Enhancing 1
billion lives by 2030 focuses our energy to improve the quality of
life for individuals around the world, giving them the opportunity
to experience the fullness of life. Our drive towards this vision
informs all of our actions-whether it is our approach to product
development, manufacturing, encouraging employee health and
wellness or giving back to the community-we strive every day to
achieve this shared goal. WE BELIEVE IN OUR VALUES
- Stand shoulder to shoulder no matter what
- We combine our best thinking and communicate openly to support
- Break through thinking
- We take smart risks, pursue innovation and challenge ourselves
to constantly improve.
- Own it always
- Every person at Emergent is engaged and accountable for
delivering on our commitments.
- Compete where it counts
- We set the right goals and respect each other as we conquer
Keywords: Emergent BioSolutions Inc, San Diego , Senior Director, PDP, Executive , San Diego, California
Didn't find what you're looking for? Search again!