Associate Principal Scientist, Microbiology AR&D

Job Description

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.

Education Minimum Requirement: 

• 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.
   

Required Experience And Skills
 

• A proven record of strong technical problem solving and laboratory experience. Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.

• 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

• Experience with MODA preferred

Leadership

• Demonstrated ability to mentor, guide, and develop laboratory staff, fostering a collaborative and high-performance work environment.

• Proven experience in managing cross-functional teams and coordinating microbiology projects to meet deadlines and quality standards.

• Strong decision-making skills and the capacity to lead by example, ensuring compliance with regulatory requirements and company policies.

#AR&D

Required Skills:

Adaptability, Adaptability, Analyti