Sr. Manager, MS&T
Company: Renaissance LLC
Posted on: January 25, 2023
All 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.
The purpose of this position is to lead a group of scientific
personnel who are responsible for the products through their
lifecycle, including the processes used to manufacture those
products. The Sr. Manager, MS&T is responsible for managing the
team involved with the technical aspects of product development as
well as commercial manufacturing. The size and scope of the
development projects will vary from small to large, will be
complex, and usually consist of high-profile development
activities. The commercial manufacturing activities will be managed
day to day by the Operations Team; however, MS&T will be
engaged in continuous improvement as well as troubleshooting. The
product profile for which the Sr. Manager, MS&T will be
knowledgeable includes, but is not limited to, nasal (Unit dose,
Bi-Dose, Multi-dose) and injectable. These products include
suspensions, solutions, and emulsions. The Sr. Manager will be
responsible for the drafting and review of documentation,
compilation, and assessment of process data, and providing
technical input for deviation investigations, change controls, and
CAPAs. The Sr. Manager will be client facing and shall work
collaboratively with clients and internal cross-functional
stakeholders to move projects forward.
As a member of the Site's Management team, participate in the
successful execution of site strategy and policies.
The Sr. Manager, MS&T works under the direction of the Director
--- Lead the technical team in the support of both development
projects and commercial production to ensure the products are
manufactured to meet the specifications including quality
--- Ensure the appropriate technical resources are available and
trained to support commercial operations and to execute development
--- Develop employees to manage all technical aspects of their
assigned products, both for development and commercial
--- Manage all technical standards and templates, including but not
limited to tech transfer reports, process development reports,
batch records, technical project deliverables and applicable
validation reports in collaboration with the validation
--- Support and direct the technical team to address issues,
deviations, CAPAs, and risks associated with production and project
execution and ensure they are communicated appropriately within the
organization and to our healthcare partners.
--- Develop and/or implement pharmaceutical packaging, both primary
and secondary level in partnership with Engineering.
--- Maintain a level of scientific knowledge in assigned area, to
include cGMP, sterile manufacturing techniques; perform scientific
literature searches and evaluations as required and understand and
comply with accepted laboratory and safety procedures.
--- Works cross functionally with Process Engineering, Operations,
Quality Assurance, R&D, EH&S, Supply Chain, Project
Management, Facilities, and other departments to effectively
maintain processes in the facility.
--- Evaluates existing processes and identifies process or
equipment improvements to advance efficiency, consistency, and
competitiveness within the market.
--- Ensure compliance with regulatory requirements including GMP,
OSHA, FDA, EPA, etc. and be the SME supporting inspections from the
--- Within area of responsibility, understand and comply with all
safety, environmental and quality practices and procedures as
outlined in organizational/departmental guidelines and SOPs as well
as applicable federal, state, and local regulations.
--- Perform other duties and responsibilities as assigned.
Master's Degree (MS) with at least 5 years related experience
and/or training; Bachelor's Degree (BS) in a Natural Science or
Engineering with at least 10 years related experience and/or
training. Experience with design of experiments (DOE) and related
multivariate experimentation approaches is desired. Must understand
concepts of QbD and pharmaceutical technology transfer.
Keywords: Renaissance LLC, Lakewood , Sr. Manager, MS&T, Executive , Lakewood, New Jersey
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