Associate Principal Scientist, Microbiology AR&D

MSD•Rahway, NJ

9d•Hybrid

About The Position

Small Molecule Analytical Research and Development (SMARD) is seeking a highly motivated Associate Principal -Microbiologist to join the growing Microbiology Center of Excellence (COE). Based our company's Headquarters in Rahway NJ, this position is responsible for supporting the full company Portfolio which includes small molecule, biologics and vaccines. As a main contributor to the implementation of new technologies and alternate microbiological methods, and – with the adequate background - The individual interacts with internal and external partners to foster collaborations and actively contributes to the establishment of our Research & Development division Micro CoE. Responsibilities include supporting the rapidly growing pipeline via collaboration with stakeholders for various projects, validations, and implementation of alternate micro methods. Providing technical guidance as well as critical thinking to help resolve scientific and technical issues. This position is based at Rahway, New Jersey, site. Additional Responsibilities: Highly capable subject matter expert in non-routine and routine testing. High proficiency in all tests, techniques and background principles of every procedure and method within the Micro area of expertise. In depth knowledge of chosen area within Microbiology. Generating new technology performance qualification protocols, their execution and generation of protocol final reports and assessment of their suitability tall within a GMP compliant standard. Inter site collaboration for new projects for the continuous improvement of the Microbiology area. To participate in Audits with regulatory bodies. To deliver training on new methods and technologies introduced into the lab. To lead constant lab flow efficiency improvements (MPS), contribute ideas on how to improve existing systems. To be proficient in highly specialized testing not common in the industry such as Mycoplasma testing. Contributes to the external scientific community (publications, presentation, consortia Drives scientific, technology, and engineering innovation with internal / externals partners Directly contributes to experimental design, execution and data interpretation for projects via individual and collaborative contributions Understands the available technologies and expertly applies them as a source of innovative solutions to pipeline problems. Anticipates and solves significant scientific and technical challenges.

Requirements

Minimum 4 years of pharmaceutical industry experience for applicants with a PhD degree; 8 years of experience with a MS degree, or 12 years of experience with a BS in Microbiology or related Biological Sciences, or equivalent with microbiological testing experience.
A proven record of strong technical problem solving and laboratory experience.
Excellent written and oral communication skills, as well as interpersonal skills.
Extensive knowledge and experience of microbiology testing in context of, environmental monitoring, aseptic manufacturing, and finished product testing in a GMP environment.
Demonstrates knowledge of rapid methodologies and relevant regulations, including bringing in and qualifying new technologies to improve turnaround time for testing processes.
Has experience with rapid technologies for sterility testing, rapid incubation of testing media, endotoxin detection, and advanced microorganism identification methods.
Expertise in nonsterile and aseptic manufacturing and associated GMP product testing.
Experience in leading and supporting quality investigations in the microbiology discipline.
Experience with internal / external audit process and authoring responses to observations.
Knowledge of current microbiology industry guidelines and compendia.
Adaptability
Analytical Method Development
Assay Development
Biological Assay Development
Biological Sciences
Biomedical Sciences
Cell-Based Assays
Chromatographic Techniques
Collaborative Development
Cross-Functional Teamwork
Endotoxin Testing
Environmental Monitoring
External Collaboration
GMP Compliance
High Resolution Mass Spectrometry (HRMS)
Liquid Chromatography-Mass Spectrometry (LC-MS)
Manufacturing Compliance
Mass Spectrometry Analysis
Microbiological Analysis
Microbiological Test
Optimism
Process Analytical Technology (PAT)
Protein Analysis
Regulatory Compliance

Nice To Haves

Experience with MODA preferred.

Responsibilities

Supporting the full company Portfolio which includes small molecule, biologics and vaccines.
Contributing to the implementation of new technologies and alternate microbiological methods.
Interacting with internal and external partners to foster collaborations and actively contributes to the establishment of our Research & Development division Micro CoE.
Supporting the rapidly growing pipeline via collaboration with stakeholders for various projects, validations, and implementation of alternate micro methods.
Providing technical guidance as well as critical thinking to help resolve scientific and technical issues.
Acting as a highly capable subject matter expert in non-routine and routine testing.
Generating new technology performance qualification protocols, their execution and generation of protocol final reports and assessment of their suitability tall within a GMP compliant standard.
Inter site collaboration for new projects for the continuous improvement of the Microbiology area.
Participating in Audits with regulatory bodies.
Delivering training on new methods and technologies introduced into the lab.
Leading constant lab flow efficiency improvements (MPS), contribute ideas on how to improve existing systems.
Being proficient in highly specialized testing not common in the industry such as Mycoplasma testing.
Contributing to the external scientific community (publications, presentation, consortia).
Driving scientific, technology, and engineering innovation with internal / externals partners.
Directly contributing to experimental design, execution and data interpretation for projects via individual and collaborative contributions.
Understanding the available technologies and expertly applying them as a source of innovative solutions to pipeline problems.
Anticipating and solving significant scientific and technical challenges.
Leading and supporting quality investigations in the microbiology discipline.
Authoring responses to observations from internal / external audit process.