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Senior Pharmaceutical Scientist

Unifin SAS
Rochester, NY Full Time
POSTED ON 1/22/2025
AVAILABLE BEFORE 4/8/2025

Senior Pharmaceutical Scientist

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 Sr. Manager Product Development ,

JOB SUMMARY :

The Sr. PharmaceuticalScientist is a senior level technical contributor providing project management,planning, execution, guidance, and the development of manufacturing, packaging,and cleaning processes for commercial products and clinical supplies. The Senior Pharmaceutical Scientist is responsible for the technicaltransfer and scale-up of commercial processes from bench through productionscale to support both internal and external customer projects. This includesthe management of and responsibility of creating protocols, dataanalysis / interpretation, and conclusions to achieve scientifically validoutcomes, including but not limited to leading project teams, writing andreviewing technical reports and evaluations, and ensuring project initiatives willachieve successful outcomes. he Sr. Pharmaceutical Scientist is responsible for technical input withregard to investigational problem solving and process / product improvements insupport of current commercial manufacturing, packaging, and cleaning operations.

Project Management

  • Work closely with business development to onboard new and existing external customers and maintain positive customer relationships.
  • Manage both external and internal customers and project timelines, action items, milestones and deliverables for smooth and timely technology transfers.
  • Provide technical leadership on project teams, manage internal cross-functional teams and maintain positive collaboration to support internal customers' needs and site initiatives.
  • Develop detailed project plans and timelines using appropriate project management tools and creates timelines in collaboration with cross functional departments (QA / Validation, Engineering, Operations, Supply Chain, external resources, etc.)
  • Closely monitor the status and results of all activities carried out under the project plan(s).Keep plans up-to-date, roadblocks and risks identified, communicated, and resolved as applicable.

Product Development

  • Provide technical expertise in process development from bench-top through scale-up, commercialization, and continued process optimization.
  • Develop manufacturing, packaging, and cleaning processes in support of product development, clinical supplies, process development / scale-up, and commercial operations.
  • Effectively identify critical process parameters with appropriate ranges to ensure robust, capable manufacturing processes.
  • Prepare development plans, protocols, and summary reports by collecting, analyzing, and summarizing data with recommending actions.
  • Provide technical leadership on project teams and task groups, ensuring scientifically valid outcomes.
  • Work with other scientists to provide coaching and guidance designed to improve their scientific skills.
  • Review documentation prepared by junior staff for the purpose of developing their skills in technical writing.
  • Support of customer NDA and ANDA submission documentation.
  • Technical Services

  • Identify and implement continuous improvement opportunities to eliminate waste and drive the business forward.
  • Conduct incident and deviation investigations to determine root cause.
  • Write investigation reports and assess product impact.
  • Collaborate with internal and external project teams to determine and implement corrective and preventative actions.
  • Your profile

    QUALIFICATIONS / EXPERIENCE :

  • Bachelor's degree in Life Science or closely related discipline required with 5-8 years' experience in the pharmaceutical industry in the area of Process Engineering, Technical Services, Product / Process Development, or Validation.OR
  • Master's degree in life science or closely related discipline with 3-5 years' experience in the pharmaceutical industry in the area of Process Engineering, Technical Services, Product / Process Development, or Validation.OR
  • Ph.D life science or closely related discipline and with 3 years of experience in the pharmaceutical industry in the area of Process Engineering, Technical Services, Product / Process Development, or Validation.
  • Excellent written and oral communication skills.
  • Thorough understanding of the drug development process.
  • Expertise in technology transfer.
  • Expertise with solid and liquid pharmaceutical manufacturing processes, equipment, and operations.
  • Must be capable of working independently, with self-initiative, self-motivation, and self-strategic direction, while also effectively working within a team and matrix environment to influence and guide activity.
  • Proven ability to work on complex problems and interpret scientific data where analysis requires an evaluation of multiple variables.
  • Solid understanding and interpretation of regulatory guidance documents and filing mechanisms.
  • Experience preparing and delivering technical presentations.
  • Ability to interact with people at all levels of the organization as well as potential interaction with auditing agencies.
  • Compensation range

    90 000,00 - 100 000,00 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!

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    Job openings at Unifin SAS

    Unifin SAS
    Hired Organization Address Rochester, NY Full Time
    HR Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare p...

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