Overview:

Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles.

Routinely and effectively interacts with clients to discuss data and methods.

Works on problems of moderate and sometimes advance scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.

Responsibilities:

Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines

Independently develop and evaluate methodologies, design and implement experiments.

Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability.

Maintains compliant records with little or no supervision

Able to write technical documents with assistance

Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks

Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions

Sets up various instrumentation for testing according to written test methods and with little to no supervision.

As needed, troubleshoots laboratory instrumentation

Leads a sample project with assistance

May participate in client level meetings, with approval

May lead and develop other team members.

May advise clients on site procedures.

May act as a team /project lead supporting scheduling of project tasks and deliverables

Responsible for ensuring compliance with cGMP and other regulatory guidelines.

Analyze information for technical correctness and accuracy

Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor

Perform routine laboratory procedures in a timely and efficient manner

Gain familiarization with analytical techniques

Participate cGMP activities

Provides input on SOPs and client questions

Maintain laboratory equipment and supplies as directed

May support peer-led laboratory investigations process with assistance

Maintain a clean and safe work-space

Maintain laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices

Participate in group and project meetings as required

Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems

Attend seminars as required

Participate in and comply with all current safety, health and environmental programs

Shows initiative and interest in learning new techniques and tests

Participates in technical discussions and brainstorming sessions

Communicates issues or challenges to senior staff and/or management

May review test data acquired by others and witness others’ notebooks

Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs

Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed

Provides input on SOPs and client questions

Effectively and routinely provides training.

With guidance, prepares well written and organized development reports

Performs other related duties as assigned.

Qualifications / Skills::

Working knowledge of experimental design, including chemistry supporting method development

Working knowledge of advanced laboratory techniques

Working exposure to cross functional techniques including organic chemistry.

Subject matter expert in one or more instruments (i.e. GC, LC, dissolution, TGA/DSC)

Able to comply to SOPs and have understanding of regulatory compliance

Working knowledge of scientific concepts, principles and procedures

Actively and positively engages with team and supports process improvements

Ability to read and execute compendial methodologies

Strong understanding of current FDA and cGMP regulations

General knowledge of chemistry and scientific calculations

Hands on experience in analytical techniques such as HPLC, GC, etc

Strong computer skills

Ability to operate laboratory equipment and computers

Ability to take direction from experienced scientists and contributes in a team

Environment

Ability to effectively train and mentor others

Good problem-solving skills

Good attention to details

Can repeat and follow detailed scientific procedures

Able to clearly present results verbally in group meetings and in written progress reports

Routinely and effectively presenting findings to clients

Good interpersonal skills and is willing to ask questions about procedures and concepts

Aptitude and willingness to gain more skills and knowledge in support of GMP regulations

Good written and verbal communication skills

Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel.

Aptitude and willingness to gain more skills & knowledge.

Good attention to detail and good problem-solving skills.

Qualifications:

S./B.A. Chemistry with 8+ years of experience in related industry or MS with 4+ years related experience or PhD with 0+ years related experience