Location: Germantown, Wisconsin, US
Department: Research and Development
Reference: VN1335
Summary of Role
The Production Support Chemist is accountable for driving results in a fast-paced environment by executing chemical reactions for programs in the commercial portfolio on a gram to multi-kilogram scale and performing routine analytical procedures to monitor reaction progress. This role requires the incumbent to efficiently organize work and properly evaluate and communicate generated data. Exercises judgment to determine appropriate action. The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile. The key funciton of the role is to troubleshoot, identifiy root cause, and provide a path forward for issues that occur at plant scale during manufacturing. Additionally, a successful candidate will be able to identify areas of improvement, conduct lab scale experiments, write reports and provide recommendation to implement at plant scale. This support chemist will act at the SME for chemical syntheses for all programs under the commercial portfolio.
Essential Functions
Key Competencies
Other Qualifications, Skills and Abilities
Education and Experience
Travel Requirement
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.
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 complemented 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.
The Production Support Chemist is accountable for driving results in a fast-paced environment by executing chemical reactions for programs in the commercial portfolio on a gram to multi-kilogram scale and performing routine analytical procedures to monitor reaction progress. This role requires the incumbent to efficiently organize work and properly evaluate and communicate generated data. Exercises judgment to determine appropriate action. The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile. The key funciton of the role is to troubleshoot, identifiy root cause, and provide a path forward for issues that occur at plant scale during manufacturing. Additionally, a successful candidate will be able to identify areas of improvement, conduct lab scale experiments, write reports and provide recommendation to implement at plant scale. This support chemist will act at the SME for chemical syntheses for all programs under the commercial portfolio.
Essential Functions
- Under supervision, executes synthesis activities from gram to multi-kilogram scale.
- Performs routine analytical procedures (e.g., KF, NMR, HPLC, XRPD, etc…) necessary for support of development activities.
- Writes project documentation (notebook entries, protocols, and reports).
- Serves as a technical contact for projects that transfer internally to the production groups (e.g., research kilo laboratory to GMP kilo laboratory, or kilo laboratory to plant).
- Conducts manufacturing investigations associated with commercial products and writes investigation reports.
- Performs routine maintenance and troubleshooting of laboratory equipment.
- Ensures timely completion of CGMP and other required training and compliance with CGMP.
- Work closely with project team engineers and analytical scientists to manage the lifecycle of commercial programs.
- 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
- Ability to perform chemical reactions at laboratory scale, isolate and purify reaction products, and analyze reaction mixtures and products using techniques such as LC, NMR, infrared spectroscopy, and Karl Fischer titration.
- Ability to analyze results and propose appropriate follow-up.
- Ability to read, analyze, interpret, review, and improve company documents, professional journals, and governmental regulations and to write, review, and improve reports, business correspondence, and procedures.
- Ability to effectively present information verbally, respond to questions from colleagues and customers, and train other Sterling employees.
- Ability to perform complex math functions and to create and interpret graphs and charts.
- Working knowledge of Microsoft Office software.
- Performs routine work without instruction, receives general instructions on new projects or assignments.
- 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.
Other Qualifications, Skills and Abilities
- This position is eligible for a flexible schedule.
- This position is not eligible for remote / hybrid work location.
Education and Experience
- Bachelor’s degree in Chemistry or related field required with minimum 1-2 years relevant experience, GMP experience preferred. The level of the role (i.e., I vs. II) will be aligned with the candidates’ experience level.
- Hands-on experience in analytical techniques such as HPLC and GC is required.
Travel Requirement
- Up to 5% travel required.
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.
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 complemented 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.
