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.
SUMMARY:
The Analytical Technologies Associate III develops, qualifies, validates, and transfers analytical methods to support drug product and drug substance manufacturing and fill-finish including release and stability testing. The Associate III captures testing and development data in an electronic lab notebook and test forms while maintaining compliance and data integrity standards. The Analytical Technologies Associate III will expand their knowledge and experience in ICH, GDP, GMP and regulatory guidelines on method development, qualification, validation and technical writing.
ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:
- Follows standard operating procedures (SOPs) and conducts analytical method transfer.
- Develops, qualifies, and validates analytical methods with minimal supervision.
- Investigates, creates, and develops new methods and technologies for project advancement under limited supervision.
- Supports assay improvement and process improvement implementation.
- Analyzes in-process, release and stability samples by battery of analytical methods and troubleshoots when necessary.
- Writes SOPs, qualification and validation protocols, and reports in collaboration with other team members.
- Communicates with internal & external stakeholders on project status, timelines, deliverables; May act as project lead or department representative for projects.
- Responsible for data review, interpretation and presenting data at team and group meetings.
- May work with Band 4 and Band 5 highly potent compounds.
- Coordinates with vendors for equipment service and training needs.
- Recommends new tools, equipment and software for CapEx purchases.
- Utilizes complex software packages such as LIMS, Agilent UV software, and other instrument software packages.
- Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Embodies PCI Pharma Servies cultural values and aligns daily actions with department goals and company culture.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in a Life Sciences discipline or equivalent required.
- Minimum of 4 years of relevant experience in a laboratory setting with an emphasis on HPLC, Uv-Vis, ELISA, SDS-PAGE and/or wet lab methods.
- Experience with analytical method transfer, qualification, and validation; hands-on experience in HPLC and other chromatographic, spectrophotometric and wet lab chemistry methods is required; Demonstrated ability to serve as an SME in at least one of the previously mentioned methods.
- Experience with one or more of the following is preferred: LC-MS, FTIR, dynamic light scattering.
- Familiarity with Agilent ELN, Chromeleon HPLC, Softmax Pro, and SoloVPE applications a plus.
- Critical thinking and excellent verbal and written communication skills.
- Ability to partner well internally in a matrix environment.
- Must be familiar with Microsoft Office applications.
The hiring rate for this position is $32.92 - $37.04/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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, Equity and Inclusion 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.
Top Skills
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
