Associate Chemist II

Bora Pharmaceuticals•Maple Grove, MN

About The Position

The Associate Chemist II will provide analytical and technical support to new product development. Completes analytical testing method improvements and various laboratory support functions in a timely manner and according to cGMP's. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Requirements

A Bachelor's Degree in Chemistry or related field with 12 credits of college chemistry
a minimum of 3 years analytical experience, preferably in the pharmaceutical industry.
Knowledge of analytical chemistry
good verbal and written communications skills.
Ability to work independently, with others and to multitask.
Working knowledge of HPLC, GC, titration, and dissolution with trouble shooting skills.
Experience with PC's, cGMP's and USP testing.
Good problem-solving skills.
Ability to understand the concepts involved in various test procedures in order to evaluate the reliability of obtained results.
Ability to write new procedures clearly and concisely which are easily understood.
Good organizational and analytical skills.
Computer skills and experience with related software.
Conduct laboratory activities with forethought, control, consistency, respect for other's needs, and safe manner.
Keeps personal workspace and shared instrument areas clean and organized.
Ability to be flexible when changes associated project needs, directions, and processes occur without impacted in productivity and efficiency.

Responsibilities

Reads, understands and follows the current USP/NF, laboratory SOPs, analytical methods and study protocols.
Documents equipment usages and analytical results in a manner that can be readily followed by reviewers and is consistent with cGMP and in-house SOPs.
Performs analytical testing according to established or preliminary methods such as cleaning validation samples, dissolutions, assay, impurities/degradation products, content/blend uniformity, pH, viscosity, titrations, general USP testing, residual solvents and other analytical methods.
Documents with clear purposes, sequences and conclusions per GMPs.
Takes ownership to assigned work and critically reviews it prior to distribution within the functional group.
Serves as instrument or procedure trainer.
Prioritizes assigned tasks and AIP goals based on work group needs with supervision.
Is able to effectively plan work and utilize discretionary time so that assigned duties are completed in a timely manner.
Reviews raw data timely and ensures it meets cGMPs and in-house SOPs, is scientifically sound and can be readily followed by auditors.
Gathers source documentation or summary data required for regulatory submissions or technical reviews.
Serves as instrument owner.
Performs required functions including reviews and audits of instrument calibrations.
Performs routine instrument maintenance and calibrations if needed.
Maintains personal and shared workspace in an organized manner.
Cleans laboratory glassware and actively participates in lab-wide routine clean up and inspection activities.
Actively participates in continuous improvement efforts associated with laboratory operation.
Works closely with supervisor or designee to complete assigned tasks and advance skills.
Writes and/or updates analytical test methods and department SOPs.
Assists with the implementation of new methods, instrumentation and new processes.
Demonstrates cooperation and professionalism with all members of the Upsher-Smith organization.
Addresses performance concerns in a timely and positive manner.
Develops/validates methods such as cleaning verifications, water activity, particle size under the direction of the department management or designee.
Writes validation protocols and reports.