Associate Scientist, Analytical Development

Sigmapharm Laboratories, LLC; Bensalem Township (Bucks County); Hybrid; USD 52,000 - 68,000; Full time

Job summary

Sigmapharm Laboratories, LLC in the United States is seeking a laboratory professional to perform physical and chemical testing across raw materials, in-process, release, and stability samples. You will record data, analyze results, and support development to approval for ANDA/NDA projects under CGMP guidelines.

The role requires familiarity with analytical instruments (HPLC, GC, Dissolution, UV-VIS, IR) and strong data interpretation, documentation, and teamwork within a regulated QC

Qualifications

• BS in Chemistry or Pharmaceutical sciences with 1–3 years of relevant laboratory experience.
• Experience with CGMPs and regulated environments.
• Ability to perform routine/new procedures with minimal supervision.

Responsibilities

• Perform physical and chemical testing of raw material, packaging material, in-process, release, and stability samples.
• Record experimental data, analyze results, and maintain notebooks.
• Support ANDA/NDA projects from development to approval with guidance.
• Assist in maintaining the laboratory in compliance with SOPs, CGMPs, FDA and OSHA.
• Use and maintain instruments such as HPLC, GC, Dissolution, UV-VIS, IR, Titrator, etc.
• Troubleshoot and perform minor maintenance and repair of lab instrumentation.
• Assist in writing technical documents (specifications, test methods, protocols and reports).

Skills

Communication skills

General Chemistry knowledge

Multi-tasking / prioritization

CGMP experience

Technical terminology understanding

Data analysis / plotting

Education

BS in Chemistry or Pharmaceutical sciences

Tools

HPLC

GC

Dissolution

UV-VIS

IR

Titrator

Job description

Description

Duties and Responsibilities

• Perform physical and chemical testing of raw material, packaging material, in-process, release, and stability samples.
• Record experimental data, analyze results, and maintain accurate and up-to-date notebooks.
• Support ANDA/NDA projects form development to approval with guidance.
• Support method development and method validation work.
• Assist in maintaining the laboratory in compliance with SOPs, CGMPs, FDA and OSHA.
• Use and maintain instruments, such as HPLC, GC, Dissolution, UV-VIS, IR, Titrator, etc.
• Troubleshoot and perform minor maintenance and repair of lab instrumentation.
• Support investigation and troubleshooting of analytical issues.
• Carry out duties in compliance with all state and federal regulations and guidelines including FDA, DEA, EPA and OSHA.
• Assist in writing technical documents (for example specifications, test methods, protocols and reports).
• Periodically review SOPs for compliance with CGMPs and revise SOPs, if necessary.
• Perform calibration and maintenance of various analytical equipment.
• Execute EQ protocols and set up qualification program for new instruments with some guidance.
• Perform calibration and maintenance of various analytical equipment.
• Assist in preparing documents for ANDA/NDA filing.
• Review USP/NF, USP/NF supplements and FPF, as applicable, to make sure company monograph and specifications meet current USP requirements.
• Assist in reviewing technical documents for content and conformance to USP such as Drug Master File, Technical Packages, Raw Material Specification and Certificate of Analysis.
• Provide formal/informal mentoring to technicians.

Requirements

Abilities / Skills

• Strong verbal and written communication skills.
• Demonstrated proficiency with General Chemistry and various analytical instruments (HPLC, Dissolution, GC, UV-VIS, IR, etc.)
• Ability to multi-task and prioritize.
• Prior experience with CGMP.
• Must be capable of performing routine / new procedures with minimal direct supervision.
• Must be able to understand technical terminology, names of drugs and ingredients used.
• Must have good understanding of basic statistics and be able to analyze/plot data in an understandable fashion.

Education / Experience

• BS in Chemistry or Pharmaceutical sciences with 1-3 years of relevant laboratory experience.

Physical Demands

• Light work (exerting up to 20 pounds of forces occasionally, and/or up to 10 pounds of force frequently) to medium work (exerting up to 50 pounds of forces occasionally, and/or up to 30 pounds of force frequently).
• Stooping-bending body downward and forward by bending spine at the waist.
• Reaching-extending hand(s) and arm(s) in any direction.
• Standing-particularly for sustained periods of time.
• Walking-moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
• Subject to Noise-sufficient noise to cause worker to shout in order to be heard above ambient noise level.
• Subject to proximity to moving mechanical parts, or exposure to chemicals.