Job Description Summary

The primary focus of this position is to lead analytical studies to support product development, validations, transfers and product release. The candidate will manage the analytical effort of multidisciplinary project teams, support internal customers in R&D, Quality, Operations, and Regulatory Affairs and author reports used in regulatory submissions such as stability. The candidate will also author complex technical reports used to justify product dispositions in case of out of specification investigations. The candidate will have extensive experience on a wide variety of analytical techniques and be able to leverage this experience to complete method development and validation for the analysis of active pharmaceutical ingredients, raw materials, coating formulations, and drug products.

Job Description

Essential Job Functions:

• Represents the Corporation, Division and Quality Department in a professional manner.
• Leads analytical programs for multidisciplinary project teams.
• Manages long-term stability studies, including organization of sample testing and result trending.
• Develops and validates new methods for analysis of pharmaceuticals, and products/subcomponents within a cGMP lab environment.
• Plans and executes studies to address product and process quality.
• Writes technical reports intended for submission to the FDA and other agencies.
• Supports product failure analysis activities.
• Transfers analytical procedures to other laboratories.
• Performs analytical testing in support of ongoing R&D and process development projects.
• Acts a primary customer interface and technical expert.
• Works independently with minimal supervision.
• Mentors bench analysts

Basic Qualifications:

Experience in a pharmaceutical analytical chemistry lab, including instrumental analysis, wet chemistry and sample prep

Hands-on experience with HPLC, UPLC, GC and other instrumental analysis

Capable of operating, maintaining and troubleshooting sophisticated instrumentation.

Excellent written and verbal communication skills, computer skills, and sound scientific judgment

Experienced at using statistical methods for data analysis and interpretation

Experienced in maintaining sophisticated software systems including LIMS and CDS

Implementation of new test methods which may include validations and transfers

Validations of instrumentation

Ability to multitask the items listed above while also assisting with mentoring bench analysts with daily tasks, including non routine situations

Additional Desirable Qualifications:

• Working knowledge of drug formulation, degradation mechanisms, and processing effects desired
• Experience with other analytical techniques including LC-MS, GC-MS, dissolution, FTIR, particulate analysis
• Experience with chromatographic data systems, statistical software, Word and Excel

Education and/or Experience:

• B.S. degree in Chemistry (or equivalent) with 5-10 years of directly related experience in a pharmaceutical analytical laboratory
• Experience with validating and transferring methods per FDA and ICH guidelines
• Extensive knowledge of cGMP requirements and procedures
• Significant hands-on experience & expertise in UHPLC method development and validation
• Experience with in-vitro and in-vivo drug coated medical device tests highly desired
• Demonstrate strong communications skills (written and verbal)
• Ability to manage/prioritize high volumes of analysis requests
• Consistent attention to detail
• Aptitude for experimental design and methods development

Becton, Dickinson and Company 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.

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Primary Work Location

USA NY - Glens Falls

Additional Locations

Work Shift

US BD 1st Shift 8am-430pm (United States of America)