CDMO, CMO, Contract Development and Manufacturing Organisation

Manufacturing Chemist

Job Title
Manufacturing Chemist
Location
Germantown,  WI 53022
Other Location
Description

Summary of Role

The Manufacturing Chemist is accountable for driving results in a fast-paced environment by safely and accurately operating process equipment and utilities.  The Manufacturing Chemist uses the Allen-Bradley Control System to control the process operations and must possess a sound understanding of reactor systems within various production units as well as all ancillary equipment such as storage tanks, waste tanks, vacuum units, and scrubber systems.  The Manufacturing Chemist must understand and be able to perform routine analytical procedures to monitor reaction progress (i.e. TLC, GC, NMR, HPLC, KF) and be able to isolate and purify products and intermediates by using standard laboratory techniques.  The Manufacturing Chemist must document using GMP Good Documentation Practices and prepare final reports for completed projects, including final procedures and compiling all analytical data.  The Manufacturing Chemist identifies equipment issues and utilizes the work order system to request maintenance and/or improvement work.  The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

  • Operates process equipment and utilities.
  • Uses the Allen-Bradley Control System to control process operations.
  • Performs chemical reactions on a gram to multi-kilogram scale.
  • Solves common synthetic problems.
  • Understands and interprets analytical data.
  • Manages and tracks project progress including monitoring timelines, raw materials, equipment availability and yields to ensure project success.
  • Prepares production areas for cGMP project initiation or changeover.
  • Produces clear documentation of all results and procedures.
  • Identifies and/or troubleshoots equipment problems.
  • Uses the work order system to request maintenance and/or improvement work.
  • Operates reactor systems within various production units. This includes knowledge of all ancillary equipment such as storage tanks, waste tanks, heating/cooling units, vacuum units, and scrubber systems. 
  • Uses the PLC Control System for operation of the unit, recognize and respond to alarms or emergency situations.
  • Utilizes the inventory system in order to properly document inventory transfers and usages.
  • Presents information and responds to questions from groups of managers, clients, customers and the general public.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Key Competencies

  • Demonstrates an appropriate level of understanding of the chemistry and operations performed in various production units.
  • Ability to read and write, and to analyze and interpret general business and technical procedures, SOP’s and regulations. 
  • Exemplary attention to detail and documentation practices.
  • Knowledge of and ability to perform routine analytical procedures to monitor reaction progress (i.e. TLC, GC, NMR, HPLC, KF)
  • Ability to perform basic math functions, compute ratios, rates and percentages.
  • Ability to draw and interpret graphs and charts.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists. 
  • Ability to isolate and purify products and intermediates by using standard laboratory techniques.
  • Ability to accurately interpret a variety of instructions furnished in written, oral, diagram or schedule form.
  • The ability to work with people at all levels of the organization. 
  • Basic knowledge of computers and Microsoft Office (Word, Excel, Outlook). 
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. 
  • Duties, responsibilities, and activities may change at any time with or without notice. 

Education and Experience

  • Possesses bachelor’s degree in a Chemistry related field or high school diploma with 3+ years equivalent experience in related field. 
  • Knowledge and prior work experience in a cGMP environment preferred.
Other Qualifications, Skills & Abilities
  • This position is not eligible for a flexible schedule.
  • This position is not eligible for remote / hybrid work location.
Physical Demands and Work Environment
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level is moderate to noisy.  Occasionally, employee may be exposed to airborne particles and fumes.  Occasionally, employee may be exposed to chemicals.  Must have the ability to wear PPE as required.  Employee occasionally may be exposed to moving mechanical parts and vibration.

Diversity and Inclusion

Sterling values diversity and we are committed to creating an inclusive environment for all employees.  All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

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