Manager Resume

OBJECTIVE

To work for a company that allows me to utilize my current skills sets as well as develop continuous improvement goals to become proficient in new ones. The ability to grow and the opportunity to advance while maintaining positive visibility for the company. Maintain professional and technical knowledge and contribute to a team effort.

PROFESSIONAL EXPERIENCE

Confidential

Manager

Responsibilities:

Leadership role to organize, prioritize and monitor multiple stability studies simultaneously. Implementation of an FDA and ICH compliant stability testing, monitoring and storage program involving various products from NDA scale batch development, engineering, clinical trials for final product filing.
Development and approval of all stability related protocols, CofA’s, Cumulative Reports.
Acted as a single point of contact to provide overall stability program oversight, work directly with clients to develop stability study protocols, data evaluation services, for submission to FDA, CVM and other regulatory agencies
Maintain an effective working relationship and resolves any operational issues with sub contract laboratories as well as internal team members.
Accurately track all stability related data trends, shelf life projections. Delegation and management of testing performed at external laboratories, maintenance and qualification of stability chambers and related equipment.
Manages and directs a team of highly skilled analytical chemists to be compliant, efficient, and method proficient to foster the ongoing development of a customer focused culture as well as ensure employees meet or exceed performance goals and strategic initiatives.
Author SOPs, initiates and drives deviations, corrective actions and change controls.
Strong knowledge of chromatography, spectroscopy, titronics.
Responsible for tracking and reporting of monthly and quarterly profit and loss for the Stability Program.

Confidential

Manager

Responsibilities:

Management of all raw materials used in development, API or drug product manufacturing for the site. Negotiated and coordinated maintenance of quality agreements, initial assessment, approval and auditing of external testing laboratories.
Interpret and stay abreast of all USP/EP/JP compendia updates and requirements with proficiency in LIMS and various electronic document management systems.
Manage direct reports performing various in - house compendia testing. Orchestrate shipment, communication of testing requirements, acceptance criteria, data review, technical review, CofA generation, release and invoicing of services through multiple contract laboratories.
Direct communication with clients and weekly updates with quality control, supply chain, project management as well as manufacturing groups.
Quality Assurance lead for internal audits, author item specifications, validation protocols, SOP’s, change controls, execute investigations, review and closure of any critical quality issues that may occur such as deviations, change controls and corrective actions.
New instrument implementation/decommission, supplier quality, and maintaining workflow scheduling for manufacturing to ensure raw material and consumable materials are released for use.

Confidential

Sr. Research Chemist

Responsibilities:

Independently conducts all reference standard characterization, monitoring and disposal of controlled drug material, retesting for analytical department. Integral member of the R&D and QC team performing analytical methods for the development/validation/transfer/qualification/release of small and large molecule materials. Under close communication with process chemists perform in-process (lab and full scale batch), routine and non-routine testing on raw materials, intermediate and final product utilizing USP compendia. Also responsible for setting and chromatography testing of stability material. All testing per cGMP, ICH, GMP, GLP.
Team lead of three direct reports, delegate data review, author of SOP’s and final reports as well as approve and initiate OOS investigations, manage multiple projects where designated as lead analyst. Responsibilities also included identification of project requirements, operations, and scope. Proficient use of HPLC, GC, GC/MS, FTIR, NMR, XRPD and IQ, OQ, PQ coordination.

We provide IT Staff Augmentation Services!

We'd love your feedback!

Resume Categories

Client Services

Job Seekers

Visa Sponsorship