Sr. Bioprocess Engineer

2 weeks ago

Rockville, United States CareerBuilder Full time

Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The Opportunity
Manufacturing Sciences supports the production of drug substance, drug product, and complex starting materials such as cell banks and plasmids. The Senior Bioprocess Engineer/Manager, Manufacturing Sciences will be a key member of the Manufacturing Sciences team, working collaboratively and leading matrix teams to ensure successful technology transfers and manufacturing campaign execution. Additionally this individual will be responsible for supporting late stage development/commercialization activities and authoring CMC content for regulatory submissions for Drug Substance and Starting Materials.
What You'll Be Doing

Support the development of technology

transfer plans and manage transfer from Process Development and into the

selected manufacturing site (internal or external) in partnership with

Process Development, Analytical Development, Quality, and the

Manufacturing Operations. Lead

necessary meeting forums (project team meetings, tech transfer working

groups) to manage technology transfer and campaign readiness.
Conduct

process fit assessments to inform manufacturing site selection and define

technology transfer scope. Partner

with Engineering and Process Development to establish requirements for

capital equipment as required.
Collaborate

with process development and other stakeholders as necessary to define the

manufacturing process requirements.

Author tech transfer deliverables (PFD, BOM, Sample Plan) to

articulate the process for transfer.
Provide

technical oversight of manufacturing processes once transferred into

manufacturing. Lead

investigation/resolution of major manufacturing deviations. Support product impact assessment for

significant quality investigations.

Provide technical assessment of proposed process changes for

potential product, supply and/or regulatory impact.
Author process change controls,

technical support memos, tech transfer deliverables, and campaign summary

reports as relevant to support manufacturing campaigns.
Support development of the control strategy and process

validation master plans. Lead risk assessments/mitigation plans as

required to support the establishment of the control strategy. Author required PPQ/CPV

protocols/reports and provide technical guidance as required to other

protocols.
Provide technical review of product related regulatory

submissions and author CMC content as appropriate. Support

partner/regulatory audits as required.
Support process risk

assessments, including mitigation plans. Establish and maintain product

knowledge expertise, ensuring critical processing knowledge is translated

effectively to operational personnel and others as required.
Administer

purchase agreements, including contract review, ensuring deliverables

progress, and invoices are per terms of contract.
We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

BS/BA in either biological or

chemical science or engineering or equivalent technical discipline.

Masters in science or engineering is preferred.
Minimum

8 years BS / 5 years MS industry experience supporting the development or

manufacture of viral vectors, biologics, pharmaceutical or vaccine

products. Experience supporting products

across multiple stages of development desirable.
Minimum

2 years industry experience transferring or receiving manufacturing

processes. Experience transferring to both internal and third party

manufacturers is desirable.
Demonstrated

scientific creativity, technical proficiency and knowledge of scientific

concepts. Expertise in cell culture/fermentation or purification unit

operations.
Proven

ability to pragmatically manage complex technical projects and

cross-functional teams.
Strong

oral and written communication skills with demonstrated ability to communicate

at multiple levels in an organization.
Experience in authoring technical documents, reports,

protocols, and regulatory submissions including (INDs, BLAs, and

equivalent).
Why should you apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.
We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more
In addition, professional development is important to us. By joining our team, youll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.

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