The opportunity
Under the direction of Sr Manager, with in depth knowledge compendia and regulatory requirements, the Sr. Analytical Development Specialist will lead the analytical team to perform complex and highly specialized tasks pertinent to analytical development/optimization, analytical support to new submission and new launch projects. The incumbent will also provide guidance as a technical leader to other group members in critical decision making and troubleshooting of complex issues.
How you’ll spend your day
Method development and method revision to improve QC productivity and efficiency.
Leads the analytical development team to perform highly complex and specialized method development and method revision tasks that require a broad knowledge base, extensive hands-on experience, and independent critical judgment.
Operates and troubleshoots analytical laboratory instruments such as HPLC, UPLC, GC, Malvern Particle Size Analyzer, Dissolution Apparatus, ICP-MS, LC-MS etc.
Provides guidance as a technical leader to other group members in critical decision making and troubleshooting of complex technical issues.
Monitors team scheduling and daily activities.
Attends cross functional meetings to support new submission and new launch projects.
Supports complex material characterization testing to support supplier driven material changes, alternative API sourcing and critical product investigation.
Supports material characterization analysis and data interpretation with various techniques such as Malvern PSD analyzer, FTIR, Image analyzer, SEM, LC-MS etc.
Reviews API suppliers’ technical packages or open part Drug Master Files.
Evaluates the physical and chemical properties of the API and determines the suitability of the alternate API to be used in the drug product.
Plans and performs required experiments including additional method development/validation when required. Proposes and justifies the changes to the current specifications.
Supports QCAD technical/scientific documentation control.
Authors and reviews technical/scientific documentation including testing protocol, test method, method validation report, method evaluation report etc.
Develops and controls testing specifications for Raw material, in process samples and finished products.
Supports Compendial Update Review.
Reviews detail of compendial updates for impacted products.
Evaluates and Identify gaps.
Provides inputs as a SME on strategies for closing the gaps.
Performs complex physical analysis, identification and synthesis of unknown impurities, and chemical structure elucidation by NMR and MS that require broad knowledge of theoretical chemistry, strategic thinking, hands-on experience and sound knowledge of pertinent analytical instrumentation, such as, HPLC/UV, UPLC/MS, GC-FID/MS, DSC, FT-IR, SEM, Particle size analyzer, NMR, MS, X-ray crystallography, etc.
Supports QC staff in technical training and troubleshooting.
Provides advice, assistance and training to QC staff as required to improve technical skills and overall productivity.
Performs other related duties as required.
