Sr. Manager, MS&T
Company: Renaissance LLC
Location: Lakewood
Posted on: January 26, 2023
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Job Description:
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.OverviewThe 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 of MS&T.
Responsibilities--- 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 considerations.--- Ensure the appropriate technical
resources are available and trained to support commercial
operations and to execute development projects.--- Develop
employees to manage all technical aspects of their assigned
products, both for development and commercial manufacturing.---
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
department.--- 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 associated
regulator.--- 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.QualificationsMaster'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.PI200403672
Keywords: Renaissance LLC, Lakewood , Sr. Manager, MS&T, Executive , Lakewood, New Jersey
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