Senior Development Chemist

Senior Development Chemist

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. 

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.

Your role

Reporting to the Lead Development Chemist,

JOB SUMMARY:
Performs method validation and development from design to execution independent of supervision.  Manage complex, multi-disciplinary projects with minimum input.  Responsible for on boarding new instrumentation and analytical techniques to support development products.  Implement improvements to lab quality systems. Provides analytical support commercial products and Manufacturing. Provides technical resource for QA laboratories.  Although this position is a senior level; this position is responsible for assisting and performing day to day laboratory testing and tasks.

Analytical Responsibilities

• Performs analytical testing to support development products from lab scale through process validation.
• Writes protocols and report.  Reviews and checks analytical data generated by peers and maintains integrity of data.
• Authors deviation and LIR independently.
• Conducts incident investigations to determine root cause.
• Assesses product impact.
• Identifies, offers, and implements plans to prevent and overcome analytical issues and performs method trouble shooting.
• Provides analytical leadership and consultation internally.
• Serves as analytical lead for customer and government regulatory agency site inspections.

 Development Products & Product Transfers (Strong Knowledge)

• Functions as Analytical Development representative and SME on project teams.
• Coordinates work to support on-time delivery of analytical data to projects.
  Provides consultation regarding new test methods as required.
• Performs analytical method development, validation and project support from design to execution.
• Authors method verification, AMTE and method validation protocols and reports.
• Provides scientifically sound, clearly written analytical data packages/reports suitable for submission.
  Writes protocols for development and engineering stability studies
• Assist in developing and validating cleaning methods for API’s when required.
• Transfers and trains commercial lab on new product methods to ensure lab readiness prior to commercialization
• Efficiency Improvements to Existing Methods

Efficiency Improvements to Existing Methods

• Evaluates regulatory changes to existing methods: i,e PhrEU and USP monograph changes.
• At customer request, investigates new technologies and analytical approaches for utilizing existing in-house instrumentation to improve test efficiency/effectiveness.
• Investigates and recommends analytical instrumentation purchases for cost improvements and operational efficiencies.
• Proactively participates in activities in support of process changes. Suggests and leads process improvements to refine current systems and improve efficiencies.

Lab Applications

• Performs feasibility and ensures instrument readiness for new product method transfers and method validations.
  Coordinates purchase, installation and qualification of new instrumentation.
• Functions as instrument data administrator. Assist in instrument maintenance and training.
• To set up new methods and products to ensure readiness prior to commercialization
• Assist in instrument transfer to LIMS
• Serves as analytical instrumentation lead for customer and government regulatory agency site inspections.
  
  

Your profile

QUALIFICATIONS/EXPERIENCE:

• Bachelor’s degree in life science or closely related
• 5-10 years of experience working in analytical laboratory experience with knowledge and/or familiarity with HPLC, GC, GC/LC-MS, FTIR, UV/Vis, SEM, CE, Chiral Separations, dissolution
• 3-5 years in Regulated Industry, Pharm preferred
• Must have previous experience in cGMP environment
• Proven success in method development and validation
  
  
  SPECIFIC SKILLS:

• Statistical data evaluation to include experimental design a plus.
• Basic Outlook and PowerPoint skills, Intermediate MS Word and MS Excel skills
• LIMS Laboratory Information Management System experience preferred

Compensation range

85 000,00 - 105 000,00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

 Learn more about us:

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential. 

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility. 

Join us and make a difference!