Scientific Associate II/ Scientist I (Cell and Molecular Analytics)
Company: CSL Behring
Location: Holly Springs
Posted on: May 14, 2022
Job Description:
Job Description Job Summary
The successful candidate will lead the efforts towards the
development of cell-based methods for potency assessment of
seasonal and pandemic sa-mRNA drug products as per current
regulatory (FDA, USP, etc.) guidance and industry standards. As a
key member of the Analytical team, you will be contributing
directly as hands-on experiments, independent analyses, and
interpretation of the data. This role will interact closely with
our process development and QC teams and lead documentation
activities for CMC-analytics related to tech transfer to QC. To be
successful in this role, you must be able to provide sound
scientific solutions, communicate clearly (in verbal and written
form), engaged to work collaboratively within team and cross
functionally to deliver exceptional results and ensure long-term
success. Additionally, this role would provide analytical assay
execution in support of vaccine process and product development
programs, including LNP potency assays as needed for the Cell and
Molecular Analytics team.
Principal Accountabilities
Development Work:
- Potency method development for drug products using various
cell-based assays and establish acceptance criteria for evaluation
and monitoring method performance
- Monitor performance of methods that are in operation both
internally and at external laboratories through trending of assay
QC data; detect and solve method performance issues
- Review and preparation of new and revised SOP associated with
the functions of the Analytical testing and analysis of sample
testing potency data in a scientifically sound manner
- Preparation of high-quality reports per regulatory guidance on
method development and qualification
- As required, provide analytical assay execution in support of
vaccine process and product development programs, e.g. RNA
activity, LNP potency, qPCR for process development or process
improvements.
- Perform review of analytical documents, checking for compliance
with Good Documentation Practices (GDPs) and Good Laboratory
Practices (GLPs)
- Oversee and coordinate analytical laboratory equipment
qualification documents.
- Oversees and advises on the development of Standard Operating
Procedures, Guidelines and other tools to support early phase CTM
testing support.
- Supports the quality and compliance training program;
collaborates with operations management to ensure staff training is
current as required by their role.
- Works with TD-QA team as liaison to ensure all quality
attributes are in place to support GLP testing.
- Work with TD-QA to close gaps related to GLP or GxP lab
requirements
- Evaluates procedures and processes affecting quality and
proposes process improvements when applicable.
- Experienced and very knowledgeable of FDA, EMA, and other
regulatory regulations.
- Experienced in managing concurrent complex projects/programs
(e.g. process improvement initiatives for lab).
- Proactively identify development and improvement
opportunities
- Able to work under tight deadlines.
- Functions effectively as core team member on multiple
concurrent projects and leads small projects and establishes work
processes.
- Data collection and reporting with knowledge of GLP/GMP
environments.
- Work closely with the Separation, Biochemistry, and Molecular
and Cellular Biology groups within TD-Analytical to provide
technical expertise for GLP/GxP requirements or lab support for
process improvements or assay development support.
- Provide support on reviewing documentation in notebooks and
reviewing data in LIMS for specific lab based processes that the
employee is trained on.
- Interface with electronic business systems (e.g, LIMS, SAP,
EDMS)Operations/Quality Support:
- Serves as interface between TD and Operations, and represents
TD department in cross-functional forums to support manufacturing
and QC
- Utilizes knowledge and experience with analytical techniques
used in biopharmaceutical (i.e., vaccines) process development and
GMP manufacturing
- Uses scientific and statistical knowledge to support product,
process and testing related investigations and deviations including
complaint, deviation, OOE and OOS investigations that require
support for development work
- Generates a supportive business case, and supports
cross-functional teams to deliver those opportunitiesPeople
Management:
- Provides guidance to new team members, interns and students and
acts as a resource for colleagues with less experienceOther:
- Completes individual training and maintains a state of
compliance
- Adheres to all safety requirements
- Supports communication/updates as required Project Work
- This position will support various projects to deliver the TD
portfolio of work as required and defined in the annual objectives
or through agreement with direct line manager.Scope/Accountability
- Accountable for own contribution to technical development
activities relating to the technical success of low to moderately
complex projects at a site level
- Scale of technical contributions impact success of projects and
adherence to budget at team level
- Functions effectively as a core team member on multiple
concurrent projects and leads small projects and established work
processes
- Provides guidance to new team members, interns and students and
acts as a resource for colleagues with less experience
- May provide direct supervision to less experienced colleagues
or technical support associatesImpact/Influence/Liaison
- Medium level of influence both internally and externally
relating to assigned products/projects
- Ability to negotiate with internal and external
stakeholders
- Delivers a range of customer, operational, project or service
activities
- Functions effectively as a core team member on multiple
concurrent projects including representing TD and ensuring TD
deliverables are provided for projects involving functions outside
of TD and leads small projects and established work processes
within TD
- Explains complex or technical information to others
- Effectively presents results in internal meetings and may
participate in external meetings
- Collaborates effectively with others in large, complex project
initiatives
- Aware of the workings of the business beyond own team
- Works in disciplined fashion with others to deliver team and
organizational results
- Technical expert resource within own discipline for functionKey
Relationships
- Internal: coordinates individual work with members of other TD
teams and other functions at the site level (QA, QC, SC, RegsCMC,
etc.), limited interactions with TD and other functions within
R&D, Operations and Quality at other sites in Seqirus and CSL
globally
- External: interacts with Vendors/suppliers to obtain goods and
services, limited interaction with colleagues in the field (e.g.,
at conferences or through collaborations), may participate in
discussions with regulatory bodies to explain own work
- Develops network of internal colleagues (primarily site based)
to share scientific knowledge, projects and best practices
- Collaborates within and across teams to break down barriers,
comfortably voicing own opinion
- Listens attentively to determine unstated needs, verifying
messages and clarifying expectationsDecision Making
- Solves complex problems through collaboration with others,
taking a new perspective on existing solutions and utilizing
technical experience, judgment and precedents
- Has autonomy to propose alternatives and exercises judgment
based on experience; normally follows a specified course of
action
- Analyze available information along with experiences of self
and others to make non-routine, more advanced decisions
- Focuses on making accurate and effective decisions in all types
of situations, analyzing results to understand outcomes and
adapting approach based on past learnings
- Delivers support to others across teams or function, initiating
dialogue and fostering cross-team exchange of ideas and
informationInnovation
- Solves complex problems through collaboration with others,
taking a new perspective on existing solutions
- Conducts independent research, development or support programs;
generates internal or external documents (e.g. publications,
patents, regulatory documents) related to own work
- Pro-actively engages with colleagues to identify complex areas
for continuous improvement and innovation within TD at the site
level with some impact on global TD or other functions, develops
the change
- Searches for information about new technologies and scientific
advances
- Seeks for 'best practice' rather than maintaining the status
quoTravel requirements
- Minimal domestic, regional & global travel is required of this
role ( Minimum Requirements
- Hands on experience developing cell based assays for
biopharmaceutical products.
- Experience with analysis of RNA is highly desired for support
of Analytical Lab Development and assay improvements.
- Excellent presentation skills, excellent communication skills,
time management, technical writing skills, PC skills, and critical
thinking and analysis.
- Ability to work effectively in a team environment and with
individuals at all levels within an organization...... click apply
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Keywords: CSL Behring, Cary , Scientific Associate II/ Scientist I (Cell and Molecular Analytics), Other , Holly Springs, North Carolina
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