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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
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 responsibility to support a wide variety and complex activities in the Quality Control Laboratory. This includes testing the following sample types R&D, in-process, finished product, stability, as well as raw materials. Job duties may also include performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management. Train others in complex analytical techniques.
JOB DUTIES
*Perform routine analytical testing of samples supporting incoming raw materials, in-process production, finished product release, long term stability and validation samples. *Ability to independently troubleshoot and solve assay and instrumentation issues *Author and/or review deviation investigation, out-of-specification or aberrant results and process changes*Act as lead in projects within the QC group and the analytical laboratory*Author and/or review of GMP documentation including test methods, protocols, reports and raw data*Independently perform analytical equipment validation, and ensure routine calibration and preventive maintenance is performed at the required intervals*Logging and tracking of samples and chemicals; order chemicals and laboratory supplies as needed*Documents/peer reviews laboratory work using laboratory notebooks/worksheets. Documentation must be detailed, timely and in compliance with cGMP/GDP requirement*Work independently with minimal supervision and direction*May participate in communication between PCI, clients, and analytical testing vendors to support activities including release testing, analytical methods transfer, qualification, validation and implementation *Other duties as assignedPROFESSIONAL SKILLS
- Strong working knowledge of analytical techniques using instruments such as: UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer, Osmometer is required.
- Technical knowledge of cGMP, ICH, USP, and global compendia regulations and guidance's, particularly as related to analytical method validation and stability studies.
- Excellent organizational skills and ability to document and present technical data.
- Proficient in MS Office. Experience with lab based data management systems a plus.
- Scientific technical writing ability including authoring and revising SOPs or technical reports.
- Experience in troubleshooting of assay and equipment issues.
- 5-7 years relevant Analytical Chemistry experience, preferably in Quality Control and in a pharmaceutical company setting.
EDUCATION
- Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of study
QUALITIES
- Excellent interpersonal skills and the ability to communicate well orally and in writing to all levels of the organization.
- Ability to multi-task in a dynamic environment with changing priorities.
- Ability to work with minimal supervision on scientific projects.
- Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment.
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
- Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear
- Ability to sit or stand for prolong periods of time
- 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
- Must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly
- Must be able to occasionally lift and/or move up to 50 pounds
- Comfortable with working/handling of hazardous materials
COMMUNICATIONS & CONTACTS
Works closely with quality assurance and quality control staff in performing varied work procedures and activities. Interacts with Operations staff.
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Join us and be part of building the bridge between life changing therapies and patients.
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.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.