Product Technology Transfer Engineer
Company: Kelly Services
Location: Olney
Posted on: April 9, 2021
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Job Description:
--Job Details:
Industry:--------------------BiopharmaceuticalWork Location:--
Gaithersburg, MDJob Title:-------------------- Product Technology
Transfer EngineerDuration:--------------------6 Months
(Temporary/Contract)Kelly Services is currently seeking an Product
Technology Transfer Engineer for one of our top clients in
Gaithersburg, MD.--JOB DESCRIPTION:Candidates will be Remote
however, may have to travel periodically (10-15%)Candidate should
have a flexible working schedule and able to support other regions
within the business.----- Note: The team will be based in the US
East Coast, CMOs receiving technology transfers are located in EU,
and Far East. Will require ability to work flexible hours to
support multiple global time zones.We are looking to augment the
GTO team working on technology transfers with a DS / DP Tech
Transfer Engineer. In this role, you will also work with GTO Drug
Substance and/or Drug Product technical stewards, R&D process
development and quality experts and partner CMO sites to support
ongoing technology transfers and process performance qualification
at the CMO. You will be expected to stay on the program for a
minimum of 6 months and up to 12 months.To succeed in this role,
you will need to be self-motivated, well organized, have strong
technical and communication skills, and a solid understanding and
hands-on experience of biologics DS and/or DP manufacturing and
quality/compliance requirements.The position provides the
opportunity to work with a highly motivated and talented global
team, working under aggressive timelines to deliver a cutting edge
monoclonal antibody manufacturing process to multiple world-class
manufacturing facilities and support efforts in dealing with the
Covid-19 pandemic.Essential Job Functions:--- Work with Drug
Substance/Drug Product Technical Stewards and SMEs from R&D,
Quality, Validation and external partner sites to support
technology transfer of drug substance processes (upstream and
downstream) to external manufacturing sites.--- Support drafting,
review and approval of tech transfer and manufacturing
documentation such as risk assessments, gap analyses, batch
records, standard operating procedures and sample plans.--- Serve
as Manufacturing /Technical point of contact on specific
workstreams/sub-projects, attending teleconferences with CMOS and
internal teams, following up with stakeholders on action items
etc.--- Update project dashboards/presentations with project status
to provide timely communication of status to internal team.
Proactively identify risks, and develop / implement work plans to
manage / mitigate / communicate risk to senior technical transfer
leads.--- Work with CMOs to compile and trend DS/DP manufacturing
process data during manufacturing campaigns.Minimum
Requirements:Education/Experience--- Degree in an engineering or
scientific discipline with experience in biopharmaceutical
Manufacturing Science& Technology/ Manufacturing/ Process
Engineering/ Quality. Prior experience in Drug Substance tech
transfers preferred.USP/DSP TT Lead ("reports" to DS TT Lead)o B.S
with 6+ years of experienceo M.S. with 4+ years of experienceo PhD
with 4+ years of experienceKnowledge/Skills--- Strong knowledge of
biologics manufacturing operations and equipment, with prior
experience in Manufacturing, Technical Operations, MFG Science and
Technology, or Quality.--- Ability to work on multiple projects and
meet deadlines as needed; emphasis on results-oriented, strong
planning and execution skills--- Strong communication skills, with
the ability to collaborate in cross functional teams across
multiple organizations--- Ability to work in a complex, dynamic,
global environmentWhy Kelly?As a Kelly Services employee, you will
have access to numerous perks, including:
Keywords: Kelly Services, Olney , Product Technology Transfer Engineer, Other , Olney, Maryland
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