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MS&T Scientist III

  • Permanent
  • Anywhere

Website KLM Careers

KLM Careers

Company : KLM Careers

Country: United States

Location : Lakewood, New Jersey

Post: Sun, 19 Sep 2021 07:12:17 GMT

Expires: Tue, 19 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

MS&T Scientist III

Lakewood, New Jersey

No Relocation – Local Candidates Only

Must be a US Citizen or Green Card holder.

The MS&T Scientist III role is essential for the business growth needs. This position will play an important role in the development of the MS&T group. The expectation from this position is to bring an outside perspective to the group. The current capacity of the group is limited and based on knowledge gained within Renaissance. An outside perspective will provide essential knowledge base which will help in improving the work quality of the MS&T group. Currently very limited individuals understand scientific principles required for developing a robust process and technology transfer/development report structure. This is an essential skill that will strengthen Renaissances position in the market as business leader in providing specialty product development and manufacturing capacity. The MS&T Scientist III will be responsible for designing, leading, and executing studies to support product and process optimization and automation, investigation on deviation and root cause analysis; technology transfer activities, and product characterization studies.

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.

Overview

As the MS&T Scientist III, the successful candidate will work on significant technical/scientific project activities to execute strategies and technical solutions that meet Renaissance’s and their client’s needs and expectations through broad expertise. The successful candidate will be expected to maintain a high level of expertise within their field and engages in creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects from client sites. Assume technical ownership of a given product across the various stages of development and commercialization in coordination with other functional areas.

The MS&T Scientist III will be responsible for designing, leading, and executing studies to support product and process optimization and automation, investigation on deviation and root cause analysis; technology transfer activities, and product characterization studies, and any other activities required by the MS&T organization.

Responsibilities

* Utilize and apply knowledge of basic scientific principles, theories and concepts to develop solutions to problems of moderate to high complexity. Lead multidisciplinary teams in developing and implementing solutions.
* Perform site transfer activities to Renaissance from business partner locations and provide scientifically sound development reports.
* Develop and optimize manufacturing processes for clinical, registration and commercial scale batches for sterile and non-sterile formulations.
* Prepare and review Master Batch Records for experimental/engineering, registration, scale-up and process validation batches.
* Prepare robust pharmaceutical/process development reports and other CMC documentation for regulatory submissions and represent Renaissance as SME during internal/external regulatory audits.
* Use statistical process control and other statistical tools for comparison and hypothesis testing. Apply engineering, pharmaceutical sciences or materials sciences fundamentals to model the product and process to solve complex technical problems.
* Evaluate and implement advance technologies for process evaluations and optimization (e.g., Process Analytical Technology, electronic batch records etc.)
* Review and provide inputs for validation master plans, validation protocols, validation reports, continued process verification (CPV) plans and statistical sampling plans, among other important strategic documents.
* Acts as internal/external Subject Matter Expert (SME) for drug product and process related technical issues and provide technical support to Formulation, Manufacturing, and Quality.
* Identify potential root causes of variation and deviations using a systematic approach. Expertise in use / application of variety of problem-solving tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc. and lead technical Deviation write-ups and CAPA assignments.
* Work closely with process engineering team to develop robust user requirement documents for process equipment including manufacturing and packaging.
* Provide technical input to management team regarding site capacity to evaluate new projects.
* Lead and guide other scientists/associates in process development and manufacturing.

Requirements

1. BS/MS/Ph.D. in pharmaceutical sciences/chemistry (or related field like organic, physical, biochemical, chemical engineering) with 6+ years (BS,), 4+ years (MS) or 2 years (Ph.D.) industrial GMP experience.

2. Experience in cGMP manufacture of commercial or late phase clinical products.

3. Experience with technology transfer and scale up is required.

4. Familiarity with statistical process control (SPC), complex data analysis,

mathematical modeling, and

optimization software (like MiniTab, JMP, etc.) is a must.

5. Knowledge and experience in cGMP, risk assessment and investigation tools and techniques.

6. Able to work on multiple projects simultaneously. Familiarity with project management concepts is preferred.
7. Proficiency with Quality by Design (QbD) concepts and design of experiments required.

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