Job Description

API Manufacturing Chemist is responsible for a cGMP, bulk chemical, manufacturing facility to perform manufacturing and process development responsibilities related to the production of Active Pharmaceutical Ingredients (API).

Reports to the Director of Manufacturing. This position will have direct oversight of API Manufacturing Technicians. They will also have interactions with other departments including Quality Control, Quality Assurance, Analytical/Stability, Validation, and Research & Development.

DUTIES AND RESPONSIBILITIES

• Maintain production duties as scheduled by API Manufacturing Supervisor.
• Lead production operations to meet scheduled timelines and goals for production.
• Oversees daily schedule and work tasks of technicians.
• Perform bulk organic synthesis and large-scale liquid chromatography.
• Perform in-process and finished product sampling.
• Perform in-process product analysis via HPLC in a cGMP regulated laboratory.
• Ensure equipment is maintained to minimize disruption to production schedules.
• Assist in troubleshooting equipment and processing problems which may arise.
• Report all issues and concerns to supervisor.
• Perform Installation Qualifications, Operational Qualifications, and Process Validations for cGMP equipment as necessary.
• Keep current on all required training and SOPs.
• Maintain/order inventory of raw materials, lab supplies, and solutions.
• Maintain a clean laboratory.
• Perform facility and equipment cGMP cleaning.
• Ensure proper cGMP documentation – maintain quality records and inventory databases.
• Write and submit deviations according to GMP guidelines.
• Assist in training of API Manufacturing Technicians
• Ensures safety protocols and policies are being followed.
• Reviews executed Mfg. Batch records for completeness, errors, and omissions before final review.

QUALIFICATIONS

• Must be detail oriented, self-motivated, have the ability to multi-task in a production environment and be capable of planning daily activities to achieve short term and long-term objectives in a quality environment.
• Must be able to follow written procedures relevant to assigned tasks.
• Must be flexible with schedule as production timelines dictate with possibility of working overtime.
• Minimum of a bachelor’s degree in chemistry or related field with emphasis and/or experience in Organic Chemistry or 3 years of work experience in a cGMP environment.
• Experience with large scale Liquid Chromatography and cGMP operations preferred.
• Effective written and verbal English communication skills required.
• Drug Screen and DEA Background check required.

WORKING CONDITIONS/PHYSICAL REQIUREMENTS

• Position is for 2nd (3pm - 12 am) and 3rd (11 pm - 8 am) shifts
• Must have no physical limitations that would prevent:
• Being able to periodically lift 50 pounds or more
• Being able to climb a ladder
• Being able to wear a full-face respirator
• During certain operations, the worker will be required to wear a full-face respirator and perform physically strenuous activity for extended periods of time.
• Will have annual occupational medical assessment to ensure “fit for duty.”
• The worker will be required to work in an environment with chemical, fall, drop, and trip hazards.
• The worker may be required to work with electrical hazards.
• The worker will be required to handle controlled substances and work in the presence of large amounts of several hazardous materials, including those that are:
• Flammable / explosive
• Carcinogenic
• Oxidizing agents
• Respiratory hazards
• Highly acidic / basic
• Under high pressure
• At high temperature
• Halogenated solvents

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