Chemists - Pharmaceutical - Formulations Analytical QC

Multiple positions listed for the Philadelphia and Central NJ areas

Formulation Scientist

Candidates will be responsible for working in pharmaceutical product formulations. There are positions available for both semi-solid formulations and for solid dosage formulation. Prior experience with sustained release tablets is a large advantage in this position. This position is responsible for formulation development, scale up and managing claims support testing of products in a timely manner. Responsibilities include prototype development, process development and stability and safety test coordination, as well as preparing and reviewing product dossiers.


Candidates must have a B.S. (advanced degree preferred) and 3+ years of experience or a M.S. with 2-4 years of experience in solid or semi-solid dosage pharmaceutical formulations.


Quality Control Chemist

The individual will report and work with the QC Manager and QC team to support testing of raw materials and development of GC methods.

Responsibilities:

•Responsible for coordinating work with project team for timely definition of and implementation of specifications.
•Develops new test methods (e.g. GC methods).
•Samples and tests raw materials, coordinates priorities with various project managers.
•Develops and validates methods for cleaning verification (mainly GC).
•Performs analytical testing of cleaning samples.
•Supports on-going projects in the development and validation of residual solvents or other GC methods.
•Assures that all raw materials received are tested in timely manner.
•Manages stock of reagents and QC supplies, and assures timely reorder of materials necessary for the laboratory.
•Prepares protocols for equipment qualification and execution of qualification tests.
•Works in the GMP laboratory in accordance with the required GMPs, and adheres to established procedures to assure compliance with cGMPs.
•Performs equipment calibration whenever necessary.
•Maintains equipment, project and general QC logbooks.
•Proposes changes for continuous improvement, either in safety, GMPs or general QC efficiency.


Analytical Chemist

Summary Analysis of finished product, in process samples, and raw materials using a variety of instrumentation in support of the timely submission of ANDAs.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Sample preparation and analysis, primarily using HPLC, and UV/Vis, and occasionally using GC, KFT, Particle Size, and FTIR.

Report preparation including the documentation of methods, techniques used, and instruments. Final product is used in the FDA submission.

Maintain a safe work environment, ensuring all instrumentation is used in accordance with SOPs.

Competencies To perform the job successfully, an individual should demonstrate the following competencies:

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.

Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.

Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.

Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.

Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions ; Uses equipment and materials properly.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals.; Completes tasks on time or notifies appropriate person with an alternate plan.

Education and/or Experience:
Bachelor's degree (B. A.) from four-year college or university in Chemistry or a related scientific field; or three plus years related experience and/or training; or equivalent combination of education and experience.
REQUIREMENTS
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