Sr. Chemist

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs.  We are a growing organization with a bright future, and we are looking for motivated and experienced team members.  We offer a comprehensive benefits and a generous Paid Time Off package. 

The position will work closely with Analytical & Method Development Chemists on executing validation protocols, method transfers, and other project activities.  This experienced person will assist in the training of lesser experienced chemists.  Audit and review analytical testing, reagent preparation, instrument calibration and validation testing performed in the Chemistry Laboratory.  Leads the support for validation projects and coordinating methods transfers from customers while supporting NPD project activities.  Assumes responsibility for Chemistry Documentation review and troubleshooting instrumentation.  

• Perform validation protocols, method transfers and write standard operating procedures for new equipment and/or processes.  
• Coordinate testing with Validation and NPD to provide chemical testing support and personnel for testing.
• Respond to Customer and interdepartmental requests for information on raw materials and method transfers availability.
• Train chemists and entry-level chemists on analytical testing on raw materials, in-process bulk material, finished product, cleaning, customer and stability samples.
• Review and approve Documentation for the release of product.  Review Standard Operating Procedure revisions and report forms to increase efficiency of chemists and maintain cGMP and GLP’s.  
• Support new NPD projects.
• Guide Chemistry Out of Specification (OOS) investigations and non-routine events.   Investigate for the root cause of the OOS.  Help to maintain a cGMP laboratory.
• Audit and review all laboratory procedures and work including:  In- process, cleaning samples, finished product, raw material and water testing; notebook, validation and expiration studies; reagent and standard preparation and instrument usage logs.
• Assist in the biennial review of SOPs and author SOPs in MasterControl
• Review procedures and train chemists on USP, EP Compendia methods
• Coordinate training of chemists and support of validation testing
• Write and revise test methods
• Write and execute validation studies
• Complete tasks as required (in a timely manner), compliant with cGMP, regulatory and corporate requirements and conform to Health, Safety & Environmental responsibilities.  
• Creating, reviewing, and revising, in addition to following/executing the following document types:
  1. Standard Operating Procedures (i.e. Laboratory Procedures)
  2. Investigations 
  3. Analytical transfer/verification/validation protocols
• Proficient and regular data reviewer of analysis following written procedures and is capable of reviewing data for projects not based on written procedures like cleaning verification protocol, method verification or validation protocols.
• Supplies complete and organized data for report generation. 
• Follows procedures as written and trains other analysts on moderate to complex techniques.
• Demonstrates multi-tasking ability and the ability to prioritize the work for multiple projects or materials on a weekly basis.
• Coordinates and performs assigned projects and is capable of organizing and leading projects involving several parts or several associates.
• Compares data to specifications, recognizes and reports (to management) atypical data and demonstrates the ability to observe and communicate trends in data and develop/contribute to “continuous improvement” plans.  Acts on data trends with limited supervisory review.
• Proficient in multiple laboratory techniques and demonstrates an in-depth understanding of one or more core laboratory techniques such as HPLC. The individual will perform these techniques on a routine basis.
• Recognized by Peers as a technical resource of broad scope.
• Demonstrates analytical problem-solving skills including troubleshooting laboratory and instrumental problems with little supervision.  Demonstrates high levels of initiative and thinking to resolve problems.   Able to resolve problems which require some independent judgment.  Proactive in taking appropriate action to resolve routine problems and helps other staff take appropriate action. Discusses actions to be taken with supervisor before resolving non-routine problems.
• Follows and is able to recommend changes to all applicable SOPs and protocols, when needed.
• Effectively communicates within the company or department as well as outside vendors.
• Communication with customers occurs under little to no supervision.  In addition, communication with professional organizations may be required.
• May make formal presentations to small groups.  
• Writes clear, concise, complex technical reports with general guidance.
• Reviews pharmaceutical publications and integrates this knowledge into everyday job activities as well as helping others do so to solve technical problems or develop new techniques. 
• Demonstrates high ethical standards.
• Evaluates and implements new analytical technology of strategic importance to WSS.  Begins to develop scientific process, understanding and skills.
• An employee in this position has the ability to make judgments based on knowledge and experience.   The work is specialized and requires creativity and a high level of judgment and ingenuity.  Focus is intradepartmental.  Decisions made have little to moderate effects on others.
• Maintain effectiveness of the Quality System components relevant to this position.
• Identify, evaluate, and manage risk to ensure product quality.  Communicate risk policies and processes throughout the organization.
• Other duties as assigned.

Education or Equivalent:  

• Bachelor of Science in Chemistry or Sciences or equivalent

Experience:   

• 5 years experience in a cGMP and/or pharmaceutical manufacturing environment

Knowledge/Skills Requirements:   

• Visual Acuity (20/30 corrected vision).
• Demonstrated intermediate mathematical ability.
• High level of attention to detail.
• Excellent documentation skills.
• A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.).
• Strong problem solving and analytical skills.
• Must possess appropriate communication skills allowing direct interaction with outside suppliers, WSS internal Managers and Sr. Management.
• Ability to work independently on multiple projects.
• Works well in a team environment.
• Possess and demonstrate excellent verbal, written and interpersonal communications skills.
• Well organized and high level of attention to detail.
• Works well under pressure and able to prioritize workloads with little or no supervision.
• Must be able to interact effectively with a variety of individuals and personalities within and between departments.
• Perform independent work related to projects and/or routine activities.
• Review reports, etc. for accuracy and logic.
• Must be able to perform risk assessments in a timely manner and act accordingly.
• Must be proactive and willing to take initiative and responsibility.
• Should be familiar with cGMP and safe work practices.
• Maintain good records, and be able to access them rapidly.  Understand where information can be found. 
• Demonstrated ability to read, write, and speak clear English.

Physical Requirements:   

• Ability to stand for up to 8 hours per day
• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, writing, talking, listening
• Occasional stooping, kneeling, crouching, bending, handling, carrying, grasping
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds