Associate Director, Process Development-Upstream
Company: Remedy Solutions
Location: Raleigh
Posted on: January 27, 2023
Job Description:
Associate Director, Process Development-Upstream
- Full-timeRemedy Solutions is a dynamic recruiting firm
representing US and International companies.A biopharm company
located in North Carolina is seeking an Upstream Process
Development Associate Director. This person will manage and serve
as technical lead for a team of 7-8 direct reports in cell culture
and harvest of mammalian cell lines (mainly CHO variants) in
support of process development, scale-up, and technology transfer
to cGMP manufacturing for Phase I through Phase III processes as
well as build and maintain client relationships.
- Serves as a subject matter expert, providing technical
oversight to the team, and training to junior scientists. Familiar
with functional area interdependencies, including cell culture,
purification, analytical, and site readiness.
- Develops the pathway/ technical direction for team
members.
- Provides technical leadership for product development efforts
in the process and manufacturing areas. Conceptualizes and proposes
process development and manufacturing based on biopharmaceutical
data. Has in-depth understanding for data analysis and
interpretation of cell culture data.
- Provides technical support for clinical manufacturing and
product testing.
- Works toward developing a broad knowledge of state-of-the-art
scientific principles, understanding of the evolving regulatory
requirements; provide technical leadership in the group, serve as
in-house advisor on key scientific discipline areas.
- Oversees cell culture-specific project plans, including raw
materials and equipment availability, in preparation of laboratory
and pilot-scale runs from their team.
- Responsible for producing high quality documentation and client
reports suitable for publication and regulatory requirements.
- Adheres to all safety requirements and assures that
departmental employees comply with required safety procedures.
- Degree within Chemical Engineering, Biotechnology or related
area:
- Master's degree with 10+ years' experience
- Ph.D. with 6+ years' experience
- Able to react to change productively and handle other essential
tasks as assigned.
- Subject matter expert in areas of process development including
high throughput technologies such as ambr, technology transfer,
scale-up of processes to pilot and manufacturing scales.
- Advanced ability with Microsoft Office (Excel, PowerPoint and
Word). Working knowledge of statistical methods for DOE design and
data analysis (e.g., JMP or Design Expert software).
- Demonstrates ability to work both independently and as a member
of a team.
- Excellent customer service skills and the ability to meet
strict client deadlines.
- Flexibility of hours to support cell culture processes over
weekend and holidays.
- Ideal Candidate will have Ph.D. and significant experience
working with mammalian cell culture and bioreactors and will have
an in-depth understanding of biological and engineering factors
that influence cell culture process performance and product
quality. In addition, demonstrated experience to lead a team and
work in multi-disciplinary team environment.All of your information
will be kept strictly confidential according to EEO
guidelines.
Keywords: Remedy Solutions, Raleigh , Associate Director, Process Development-Upstream, Executive , Raleigh, North Carolina
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