Analytical Development Scientist II

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

JOB SUMMARY:

This position will have primary responsibility for supporting all activities within Quality Control Analytical Development, with special emphasis on supporting testing for R&D projects utilizing cGMP knowledge and skills for analytical test methodologies and practices. This role is the second level within the Analytical Development Scientist job family. The incumbent must possess knowledge of commonly used concepts, practices, and testing methodologies, demonstrating technical proficiency and scientific skill 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 supporting method qualifications / transfers, as necessary.

JOB DUTIES:

• Perform routine and complex analytical testing of samples supporting process development.
• Document laboratory work using laboratory notebooks/worksheets. Documentation is detailed, timely and in compliance with GDP 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.
• With assistance from senior scientist(s), develop, qualify/validate, optimize, and/or transfer analytical methods suitable of intended use assuring project timelines are met
• May be assigned tasks to work independently with minimal supervision and direction.
• Other duties, as needed

• Must have strong attention to detail as well as ability to work in a cross-functional team environment.
• Strong organizational skills and the capacity to work within a fast-paced environment
• Knowledge of Quality Control testing requirements
• Strong competence for logical, analytical, and strategic thinking
• Problem analysis and resolution skills desired
• Knowledge of cGMP, ICH, USP, and global compendial regulations and guidance, particularly as related to analytical method development and validation
• Adept at presenting organized technical data
• Functional to proficient skills in MS Office and familiar with lab-based data management systems
• Scientific technical writing ability including authoring and revising SOPs or technical reports

• 5+ 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
• Familiar with analytical testing using some of the following types of equipment: HPLC/UPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Osmometer, pH.
• Experience in Analytical Method Development and/or Validation is preferred

• Bachelor's degree in a scientific field with 5 or more years' experience in a cGMP laboratory environment

QUALITIES:

• Good interpersonal skills and the ability to communicate well both orally and in in writing
• Able to multi-task in a dynamic environment with changing priorities
• Resilient, can quickly move forward despite challenges
• A drive to achieve results while working with limited supervision
• Positive attitude with strong team and cross team collaboration
• 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

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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.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.