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JOB SUMMARY:

This position will have primary responsibility for supporting all activities within Quality Control Analytical Development, with special emphasis on supporting method transfers/validations and R&D projects utilizing cGMP knowledge and skills for analytical test methodologies and practices. This role is the third tier within the Analytical Development Scientist job family. At this level, the incumbent is expected to demonstrate advanced possess advanced knowledge of commonly used concepts, practices, and testing methodologies, demonstrating technical proficiency and scientific ingenuity as they carry out their duties in collaboration with analytical development team members and cross functional colleagues. Additional areas of responsibility include but are not limited to performing cleaning validations and method verifications as well as writing instrument and method SOP's as necessary.

JOB DUTIES:

• Perform routine and complex analytical testing of samples supporting process development.
• Develop, qualify/validate, optimize, and/or transfer analytical methods suitable of intended use assuring project timelines are met
• Document/review laboratory work using laboratory notebooks/worksheets. Documentation is detailed, timely and in compliance with Process Development requirements
• Log and track samples and chemicals as well as order chemicals and laboratory supplies as needed.
• Troubleshoot assay methods and instrumentation issues as necessary
• Proactively identify assay issues, new assay needs and provide scientific suggestions and solutions.
• Author, and/or review of GLP/GMP documentation in accordance with GDP requirements, including protocols, reports and raw data
• Assist in bringing new technology and equipment into the QC lab.
• Mentor/guide junior Quality Control analysts on daily laboratory work, experimental design, data interpretation and troubleshooting. Train new group members on analytical lab skills.
• Work independently with minimal supervision and direction.
• Other duties, as needed

PROFESSIONAL SKILLS:

• Must have excellent attention to detail as well as the ability to work in a cross-functional team environment.
• Highly advanced organizational skills and the ability to work within a fast-paced environment
• Multi-disciplinary knowledge of Quality Control
• Advanced capability for logical, analytical, and strategic thinking
• Problem analysis and resolution skills required Experience working in a laboratory under cGMP, ICH, USP, or global compendial regulations and guidance, particularly as related to analytical method development and validation
• Highly effective and capable or presenting technical data to guide and influence
• Advanced skills in MS Office and lab-based data management systems
• Scientific technical writing ability including authoring and revising SOPs or technical reports
• Highly skilled at troubleshooting of assay and equipment issues

EXPERIENCE:

• 10+ years' experience in a cGMP organization
• Experience working in a contract manufacturing/development environment preferred.
• Experience working in a cGMP laboratory environment is highly preferred
• Proficiency with performing analytical testing using several of the following types of equipment: HPLC/UPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Osmometer, pH is required.
• Experience in Analytical Method Development and/or Validation is preferred

EDUCATION:

• Bachelor's degree in a scientific field with 10 or more years' experience in a cGMP laboratory environment

QUALITIES:

• Excellent interpersonal skills and the ability to communicate well both orally and in in writing
• Highly proficient at multi-task in a dynamic environment with changing priorities
• Resilient, not deterred by challenges and can quickly move forward despite issues or obstacles
• A drive to achieve results while working with limited supervision
• Maintains a positive outlook, able to work in a highly collaborative environment while balancing independent thinking.
• Honesty, integrity, respect and courtesy with leadership and peers
• Strong commitment to conducting LSNE business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of LSNE products and services

PHYSICAL REQUIREMENTS & MENTAL DEMANDS:

• Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs.
• Capacity to work on several tasks simultaneously.
• Able to organize and prioritize work activities.
• Must be able to walk and drive between locations
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
• Comfortable with working/handling of hazardous materials

COMMUNICATIONS & CONTACTS:

• Works closely with the Quality organization in performing varied activities.Interacts with all departmental staff to coordinate activities.

TRAVEL: <10%

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.