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Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Scientist also provides mentoring to analysts.

Job Description

The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists.

+ Support microbial testing for commercial and pre-commercial products

+ Support method development, validation, and transfer activities

+ Perform complex microbial analyses using lab equipment

+ Investigate complex product issues and support product development

+ Manage method lifecycle activities

+ Write and review SOPs, test methods, and validation documents

+ Serve as a subject matter expert (SME) in microbial testing

+ Mentor Scientists and Microbiologists

Key Responsibilities

+ Perform routine microbiological testing on raw materials, in-process samples, and finished products

+ Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests

+ Analyze environmental monitoring samples from cleanrooms and production areas

+ Support Validation of microbial methods for product and raw material testing

+ Prepare protocols, reports, and test methods

+ Conduct testing to support development and stability studies

+ Present and review data with project teams

+ Review lab documentation and supplier technical documents

+ Use lab software and detect abnormalities during testing

+ Provide general lab support and maintain equipment

+ Troubleshoot instruments and perform follow-up analyses

+ Report and investigate out-of-specification results

+ Write and review SOPs and investigation reports that support root cause analysis

+ Recommend corrective and preventive actions (CAPA)

+ Support training of microbiologists and improve training process records

+ Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

+ Ensure compliance with FDA and other regulatory standards

+ Follow safety procedures and handle hazardous materials properly

+ Uses laboratory software for analyses

+ Is alert to and detects abnormalities during performances of tests and reviews

65%

Lab Equipment

+ Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping

+ Troubleshoots instrumentation and performs subsequent analyses

20%

Investigations

+ Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action

+ Participates in root cause identification of complex laboratory investigations

+ Writes, edits, and reviews SOPs and laboratory investigations

10%

Training

+ Trains microbiologists

+ Continuously updates knowledge with respect to the latest technologies related to Microbiology

+ Maintains assigned training records current and in-compliance

+ Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, methodologies and procedures

5%

Compliance

+ Identifies need for SOPs and writes or revises, as appropriate

+ Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations

+ Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs

+ Takes active role in auditing laboratory logbooks/documentation to ensure compliance

+ Follows internal processes related to controlled substances

continuous

Safety

+ Follows EH&S procedures to ensure a safe work environment

+ Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS

continuous

Total

100%

Qualifications

Education & Experience

_Minimal acceptable level of education, work experience and certifications required for the job_

+ Bachelor of Science Degree in Microbiology or related field with 6 years’ relevant microbiological laboratory experience OR

+ Master’s Degree in above disciplines with 4 years’ relevant analytical lab experience OR

+ PhD in above disciplines with some relevant laboratory experience preferred

Knowledge

_Proficiency in a body of information required for the job_

_e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._

+ Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc.

+ Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, etc.

+ Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS

+ Has demonstrated competence in conducting microbial testing

+ Strong knowledge of aseptic technique and contamination control

+ Competency in Microsoft Office Suite

Skills

&

Abilities

_Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing_ _etc._

+ Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information

+ Ability to display and analyze data in a logical manner

+ Strong verbal and written communication skills as well as good computer skills

+ Strong attention to details and accurate record keeping

+ Establish and maintain cooperative working relationships with others

+ Solid organizational skills

+ Ability to coach and mentor junior staff while developing their laboratory skills and technical capabilities

+ Ability to take initiative, set priorities and follow through on assignments

Physical Requirements

_Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc._

+ Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals

+ Must occasionally lift and/or move up to 15-25 lbs.

+ Ability to wear personal protective equipment, including respirators, gloves, etc.

+ Specific visions abilities are required by this job include close vision and color vision

+ Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods

**_Disclaimer:_** _The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required._

EEO Statement:

We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.