CDMO, CMO, Contract Development and Manufacturing Organisation

Analytical R&D Scientist I

Job Title
Analytical R&D Scientist I
Location
Germantown,  WI 53022
Other Location
Description

Summary of role

The Analytical R&D Scientist I is accountable for driving results in a fast-paced environment by independently executing development of analytical methods and improvement of existing ones to support API development program for Sterling facilities. This requires skills and knowledge in handling, analyzing and characterizing chemicals, pharmaceuticals, and related organic molecules. It also requires hands on experience in analytical techniques such as HPLC, GC, etc. The Scientist independently drafts analytical development reports and drafts and executes validation protocols for analytical methods. The ideal candidate will independently perform and review data analysis and draft reports for analytical method development and validation. The ideal candidate has the proven ability to apply scientific principles, theories and concepts to research problems and develop solutions for analytical problems related to drug substances in compliance with appropriate Standard Operating Procedures (SOPs) and regulatory guidelines.  The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

  • Demonstrates technical ability to assist in the design and execution of non-routine experiments with supervision.
  • Demonstrates ability to correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up with supervision.
  • Demonstrates ability to perform literature searches and extracts relevant information from published protocols and journals.
  • Performs routine maintenance and troubleshooting of analytical equipment with supervision.
  • Manages a variety of aspects of analytical projects with minimal supervision of AR&D Supervisor/ Manager.
  • Provides project related updates to internal and external customers.
  • Writes project documentation (analytical test methods, developmental reports and protocols) of medium complexity with minimal input from supervisor.
  • Establishes and coordinates activities at contract chemical and analytical laboratories, as required.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • Ensures information security is carried out while performing day-to-day functions, duties and tasks.
  • Accesses, uses, and safeguards sensitive, valuable, or critical proprietary information in a reliable manner to ensure company and information security.
  • Knows and adheres to Standard Operating Procedures (SOPs) and performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions.
  • 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

  • Knowledge of theories and principles of synthetic organic chemistry.
  • Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations. 
  • Ability to write reports, business correspondence and procedure manuals. 
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
  • Ability to perform complex math functions, compute ratios, rate, and percent. 
  • Ability to draw and interpret graphs and charts.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
  • Ability to work with people at all levels of the organization. 
  • Able to work independently and as part of a team on projects.
  • Basic knowledge of computers and PC’s.
  • Ability to use windows based software including MS Office and chromatography data collection software.
  • Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
  • 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

  • Bachelor’s degree in a scientific discipline such as analytical chemistry, or related field with 9+ years of experience, or
  • Master’s degree in a scientific discipline such as analytical chemistry, or related field, with minimum of 3+ years of industrial experience, or
  • Doctoral degree in a scientific discipline such as analytical chemistry, or related field, with minimum of 0-2 years of industrial experience 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.

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