Method Dev/Validation 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.

I. Position Overview:

The primary function of a method development/validation chemist is to support analytical chemistry method development and validation projects for raw materials including Active Pharmaceutical Ingredient (API) and finished products. This can include method development and optimization, method transfer, method validation/re-validation and method verification.

Secondarily, the method development/validation chemist will support in-process, raw material and finished product release as needed.

II. Specific Duties, Activities, and Responsibilities:

• Provide support for analytical chemistry method development/optimization, method transfer, validation, and verification.
• Work directly with customers on analytical methods. This can include method development and optimization, transfer or verification of existing external methods into the WSS QC chemistry lab.
• Support API and FP release testing and peer review once method implementation is complete.
• Define experimental designs for analytical method development and optimization. Define required laboratory equipment and instruments and onboard instruments as needed.
• Define project scope for method transfers, validation and verifications.
• Guide and author chemistry investigations and non-routine events.
• Author standard operating procedures for new equipment and/or test method.
• Act as technical subject matter expert on multi-disciplinary project teams.
• Ensure that key technical milestones with internal and external stakeholders are achieved so that the overall project can progress in a timely manner. Communicate changes and risks with project managers, internal team members and customers, as required.
• Work on complex problems of diverse scope where analysis of data requires evaluation of intangible factors. Collect and reduce experimental data and analyze results of tests.
• Exercise independent judgment in developing methods, techniques and evaluation criteria. Demonstrate success in technical proficiency, collaboration with others, influencing and independent thought.
• Demonstrate Good Documentation Practices.
• Consult with and utilize external resources (academic and industrial), guidance documents, standards and regulations as necessary to ensure appropriate knowledge base is established for actions and decisions.
• Utilize Design of Experiments, Risk assessments, Quality by Design, and statistical tools to identify and quantify problems and solve them early in development process.
• Comply with Health, Safety and Environmental responsibilities for the position.
• Maintain effectiveness of the Quality System components relevant to this position, including sponsoring change controls, deviations, and CAPAs when required.
• Provide training to other chemists post to method implementation.
• Cross-train on duties and activities of the Sr. Chemist and Lead Chemist to provide production support.
• Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
• Other duties as assigned.

III. Position Requirements:

Education or Equivalent:

• Bachelor of Science in Chemistry or relevant discipline required.

Experience:

• Minimum of 7 years relevant experience in a cGMP and/or pharmaceutical manufacturing environment or combination of lower experience with strong academic experience.
• Extensive experience with HPLC is required.
• Experience with GC and GC/MS is required.
• Experience with particle size distribution analysis is beneficial.

Knowledge/Skills Requirements:

• Visual Acuity (20/30 corrected vision).
• Strong experience with analytical method development, validation and transfers.
• Proficient in multiple laboratory techniques and demonstrates an in-depth understanding of one or more core laboratory techniques.
• Should be familiar with applicable regulatory guidelines and USP monographs.
• Strong experience with HPLC analysis. Empower experience is preferred.
• Strong experience with wet chemistry and laboratory techniques.
• General experience with instrumentation for testing of chemical and physical attributes.
• Problem-solving skills, analytical skills, and a high level of attention to detail required.
• Excellent documentation skills.
• Excellent communication skills both written and oral at all levels within the organization.
• A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.).
• Must possess appropriate communication skills to interface with both technical and non-technical customer representatives.
• Must possess appropriate communication skills allowing direct interaction with outside suppliers, WSS internal Managers and Sr. Management.
• Ability to work independently and/or in a team environment on multiple projects.
• Ability to be flexible and adapt to ever-changing expectations/priorities.
• Should be familiar with USP chapters 1224 and 1225 for method transfer and validation.
• Should be familiar with cGxP or be able to quickly learn and apply cGxP principles and must be able to follow safe work practices.
• Demonstrate a willingness to share skills and information with others.
• Blend knowledge and analysis with logic and active listening. Act ethically.
• Demonstrate a bias toward action. Be a vocal contributor to project teams, helping to guide the project direction and execution. Foster teamwork to get results.
• Demonstrated ability to read, write, and speak clear English.

Physical Requirements:

• Ability to work with various chemicals including potent compounds.
• Ability to stand for up to 8 hours per day on occasion.
• Frequent sitting, standing, reading of written documents and use of computer monitor screen.

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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