Senior Commercial Analytical Scientist - Sterling Pharma Solutions at Sterling Pharma Solutions in Germantown, Wisconsin

Job Description:

Summary of Role

The Senior Commercial Analytical Scientist develops analytical methods and performs analytical testing in support of Commercial cGMP manufacturing. The Senior Commercial Analytical Scientist is responsible for supporting unexpected manufacturing events with an emphasis on analytical testing and providing on-going analytical support of commercial manufacturing. The Senior Commercial Analytical Scientist works closely with Production Engineers, Support Chemists, Research and Development, QC, QA and regulatory, and EHS to ensure robust production and testing of cGMP API materials. The Senior Commercial Analytical Scientist also provides leadership, technical guidance, training, advice, and development to junior colleagues and serves as liaison between the development team and quality control. The position requires superior leadership behaviours, execution of the Sterling Values, core competencies, and non-negotiables, as well as expertise in functional competencies included in this position profile, and substantial hands-on experience with a wide variety of analytical techniques and principles with the ability to work under minimal supervision.



Your Responsibilities

• Perform development and validation, routine testing, and non-routine testing for a wide variety of analytical techniques/instrumentation including appearance, IR, Karl Fischer, TGA/DSC, HPLC, GC, IC, ICP, and solid-state characterization techniques such as XRPD, particle size distribution, rheometry, and microscopy.


• Conduct testing to support process improvement/optimization projects.


• Conduct testing to support deviation and manufacturing investigations including R&D investigations for commercial projects.


• Perform training and provide mentorship for junior colleagues.


• Analyze data/results and interpret outcome of experiments, draw scientifically valid conclusions, identify possible trends, and propose follow-up actions with limited supervision.


• Perform data, protocol, and report peer review prior to finalization for GMP use.


• Ensure timely completion and compliance with cGMP regulations, Sterling SOPs and policies, and all other relevant company training requirements.


• Serve as site SME for the cleaning method development and validation program, manages solubility and cleaning information forms, and provides guidance and oversight for method standardization initiatives.


• 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.

Requirements for the Role

• Bachelor's degree in chemistry or related field with 5+ years of experience in an API GMP manufacturing facility.


• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures and governmental regulations.


• Ability to perform complex math functions, compute ratios, rates, and percentages.


• Previous work experience in a regulated environment.

What We Offer

We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.



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.



Location

This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.



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.

Sterling Pharma Solutions is an equal opportunity employer.

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