Sr. Manager, Sterility Assurance
Company: Renaissance LLC
Posted on: January 15, 2021
Renaissance LLCAll qualified applicants will receive
consideration for employment without regard to race, color, sex,
sexual orientation, gender identity, religion, national origin,
disability, veteran status, age, marital status, pregnancy, genetic
information, or other legally protected status.Overview
The Sr. Manager, Sterility Assurance is responsible for the overall
performance of the sterility assurance group and its functions. The
purpose of this position is to lead a group of scientific personnel
in the execution and timely completion of projects. The position is
expected to use their knowledge and skills to mentor/advise less
experienced members within the group. The individual will manage
the sterility assurance group and ensure compliance with all
regulatory guidance, Renaissance procedures and good documentation
practices. The individual is responsible for being the SME for all
related procedures pertaining to sterility assurance and aseptic
manufacturing. This includes but is not limited to Media
Challenges, Smoke studies, Sterilization, Aseptic Manipulations,
Clean room management. Gown Training, and Clean room behavior.
Responsibilities may also include interviewing, hiring, training
employees, planning, assigning, and directing work; appraising
performance, rewarding and disciplining personnel, addressing
complaints and resolving issues.
This position may also interact frequently with
regulatory/compliance personnel at Renaissance Lakewood, LLC. It
will assure compliance to all FDA and international regulations
with regard to sterility assurance activities. The employee in this
role must be able to represent Renaissance with customers and
- Provide technical expertise and understanding on the
qualification and requalification approach surrounding media fills,
dose audits, EMPQ, and sterilization activities.
- Develop Design of Experiments (DOEs), develop statistical
sampling plans, assess and approve quality attribute requirements,
as well as performing statistical analysis and evaluation of data
to draw technical conclusions and make decisions.
- Review and approval of documents including, Sterilization, Dose
Audit Reports, Impact Assessments, and Media Fill
- Implementation of applicable regulatory requirements and
guidance ensuring compliance with FDA, ISO, EMA and any other
applicable domestic and international regulations and / or guidance
- Schedule, plan, manage, and deploy resources to support
sterility assurance activities and efforts, as needed, to ensure
Renaissance and customer timelines are met.
- Provide technical assistance for investigations into
process/product issues in support of sterility, media fill, EMPQ
and dose audit deviations and review of design requirements for
aseptic products and or equipment.
- Interface with customers on transfer discussions, timelines,
project deliverables, etc.
- Effectively manage personal activities and manage the
timeliness of the team as well as participate and/or lead/manage
project related team activities. The candidate must be able to
report project status and team performance capability to cross
functional team members and site leadership.
- Generate and maintain the container closure integrity,
environmental monitoring auditing, dose auditing and aseptic media
process simulation program plans including incubation requirements
and available space.
- Manage the site Media Challenge program.
- Manage the site Smoke Studies program.
- Bachelor of Science degree in a Science, Engineering or other
related field required. Advanced education is preferred.
- Minimum of five (5) years' relevant experience performing in an
aseptic pharmaceutical environment is required.
- Familiarity with current industry practices and guidelines
including those required / outlined by the FDA, ISO, EU and ICH.
Examples of successfully interacting with the FDA and governing
- At least 3+ years of leadership experience with direct reports
- Must have experience with qualification for EMPQ, media fill,
dose audits, aseptic manipulations, clean room management and/or
- Demonstrate examples utilizing DOE and statistical sampling
plans to identify, assess and implement quality changes
- Demonstrate examples of dealing with customers; fixing an
issue, meeting & managing project timelines and/or managing
technology transfer activities
Strong problem-solver with emotional maturity and servant
leadership mentality PI127909857
Keywords: Renaissance LLC, Lakewood , Sr. Manager, Sterility Assurance, Executive , Lakewood, New Jersey
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