CDMO, CMO, Contract Development and Manufacturing Organisation

Production Chemist

Job Title
Production Chemist
Germantown,  WI 53022
Other Location

This is on a 2-2-3 rotation from 6pm-630am starting pay at $23/hour with $3.50 shift premium and up to $4,000/year shift bonus

Summary of Role

The Production Chemist is accountable for driving results in a fast-paced environment by safely and accurately operating process equipment and utilities, while simultaneously understanding reaction mechanisms and applying them to practical execution of given synthesis.  Provide feedback on the potential for optimization of conditions to proposed and designed synthetic routes such as equivalents, cycle times, work up procedures, and yields.  The Production Chemist must understand reaction pathways, principals of chemistry and chemical behaviors and how they may impact process design and performance. The Production Chemist utilizes process equipment and the PLC Control System to regulate the process operations and possesses a sound understanding of all reactor systems within the production unit as well as all ancillary equipment such as filtration systems, vacuum units, scrubber systems, and mills. The Production Chemist must document using GMP Good Documentation Practices (ALCOA) when preparing reports, compiling data, and executing production records.  The position requires superior demonstration of the Sterling core behavioral competencies and non-negotiables, as well as expertise in functional competencies included in this position profile. 

Essential Functions

  • Synthesizes, isolates and purifies products and intermediates by using standard chemistry techniques from gram to tonne scale.
  • Perform stoichiometric calculations with an understanding of the resultant process balanced equation.
  • Utilizes the PLC Control System to monitor and control the process for unit operations and recognize and respond to alarms or emergency situations; ensuring safe, high quality and “right first time” production.
  • Pays extreme attention to batch record details to ensure all procedures are closely followed, order of operation accurately performed and correct additive and volume is applied to the process.
  • Understands common synthetic problems to support troubleshooting.
  • Reviews and provides input on new batch instructions and works directly with Development to make suggestions on how to execute various unit operations.
  • Understands and interprets analytical data produced from testing.
  • Produces clear documentation of all results and procedures, utilizing GMP Good Documentation Practices (ALCOA).
  • Manages and tracks process progress including monitoring timelines, raw materials, equipment availability and yields to ensure success.  Provides written and verbal updates to supervisors or internal departments as appropriate.
  • Utilizes work order system to request maintenance and/or improvement work and tracks activities through completion.
  • Utilizes inventory system to consistently and properly document inventory transfers and consumptions, per SOP and cGMP guidelines.
  • Accesses the Management of Change System to review changes that affect the job position, shares information with peers to ensure understanding of impact.
  • Prepares production areas for cGMP project initiation or changeover.
  • Keeps current in new developments within the chemistry/chemical industry.
  • Possesses a continuous improvement mentality, providing input and suggestions on existing procedures or help with the creation of new ones.
  • Demonstrates understanding and adherence to all cGMP systems.
  • 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.

Education and Experience

  • B.S. Degree (Science-based preferred) or High School diploma with equivalent experience

Key Competencies

  • 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.
  • The ability and tact to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
  • Ability to perform basic math functions, compute ratios, rates and percentages.
  • Working and conceptual knowledge of reactor systems within production units; includes ancillary equipment such as filtration systems, vacuum units, scrubber systems, waste tanks, temperature control systems, and mills.  The incumbent will demonstrate this process knowledge through written and/or oral proficiency examinations.
  • 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 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. 
  • No direct reports, but accountable for leading and influencing others.
  • Coaches, mentors and develops other employees.
  • Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
  • Basic knowledge of computers and Microsoft Office (Word, Excel, Outlook). 

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.

Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 

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