Job Description
As part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Bioseparation Sciences (BSS) department provides the technical downstream process leadership and laboratory capabilities in support of late stage pipeline and commercial drug substance manufacturing processes for vaccines and biologics. For pipeline programs, BDSC supports various commercialization activities including process characterization, process science support for technology transfer to internal and external manufacturing sites, manufacturing investigation, process validation, and authoring of regulatory submissions. For commercial programs, BDSC supports process improvement, post approval next generation process development and characterization, manufacturing investigation, process validation, and regulatory submission authoring.
Under the general scientific and administrative direction of the technical leader in downstream and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule programs within BDSC. This individual will demonstrate scientific and experimental skills focusing on downstream processing.
Technical Scope

• Participates in teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.
• Responsible for laboratory-scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally.
• Provides technical leadership for the design of experiments, data analysis and interpretation, as well as the execution of (internal) or management of (external) laboratory activities.
• Primary focus will be on downstream processing, but with an emerging knowledge of the various aspects of drug substance manufacture and functional area interdependencies, including cell culture, analytical, and site readiness.
• Actively interacts with internal and external partners. May represents functional area on cross-functional teams.
• Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to standard of our Company practices.

Education Minimum Requirement:

• BS or MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 6 years (for BS) or 4 years (for MS) relevant experience. PhD candidates with 0+ year(s) of relevant experience will also be considered.

Required Experience and Skills:

• Technical background in purification of biological molecules, including laboratory models for chromatography and filtration systems.
• Hands on experience in small scale laboratory downstream process.
• Strong fundamental knowledge in downstream processing of biologics.
• Excellent oral and written communication skills. Demonstrated ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc. in a multi-disciplinary team environment.

Preferred Experience and Skills:

• Experience with downstream purification of biological molecules required, with an in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.
• Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture.
• Prior experience in late stage process development, process characterization including viral clearance studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
• Working understanding of analytical methods to characterize biologics and/or US/EU regulatory requirements and/or working knowledge of cGMPs is a plus

NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
05/19/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:05/19/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R281372