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    Senior Development Chemist - Rochester, United States - Unither Pharmaceuticals

    Unither Pharmaceuticals
    Unither Pharmaceuticals Rochester, United States

    1 week ago

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    Description
    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. Manages complex, multi-disciplinary projects with minimum input. Implements improvements to lab quality systems. Provides analytical support commercial products and Manufacturing. Provides technical resource for QA laboratories.

    .


    ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
    Solutions that Minimize Commercial Lab & Manufacturing Downtime

    Conducts incident investigations to determine root cause. Assesses product impact.


    Works with the appropriate discipline to identify corrective/preventative measures necessary for each observation made for improvement and to align processes to consistently manufacture quality products.


    Coordinates documentation required at the completion of investigations; pulls all materials together into a concise summary that thoroughly documents the conclusions of the investigation.

    Collaborates with internal groups to determine and implement preventative measures to reduce/eliminate repetitive deviations.

    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.

    Methods for New Products & Product Transfers (strong knowledge)

    Coordinates work of lab personnel to support on-time delivery of analytical data to projects.

    Functions as Analytical Services representative and SME on project teams.

    Provides consultation regarding new test methods as required.

    Performs analytical method development, validation and project support from design to execution.

    Provides scientifically sound, clearly written analytical data packages/reports suitable for submission.

    Writes protocols and reports. Reviews and checks analytical data generated by peers and maintains integrity of data.

    Internal Analytical Support

    Provides analytical solutions to manufacturing troubleshooting, process development and improvements.

    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.

    Laboratory Training Program


    Builds systems that translate training and development needs into appropriate, cost-effective learning and development interventions that support the effectiveness of the individual and the Labs.

    Develops methods to transfer information and techniques from training sessions to actual on-the-job performance.


    Evaluates training effectiveness by using pre-test and post-test measures, interviews, and examining various records and reports; and recommends modifications to training as appropriate.


    Delivers one-on-one or group training to individuals on assigned processes that includes not only information on the process, but the opportunity to practice.

    Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems.


    SPECIFIC SKILLS:
    Statistical data evaluation to include experimental design a plus.

    Basic Outlook and PowerPoint skills, Intermediate MS Word and MS Excel skills

    Your profile

    Bachelor's degree in life science or closely related discipline AND 10+ years of experience

    Master's degree in life science or closely related discipline AND with 7+ years of experience

    Ph.
    D life science or closely related discipline AND with 5+ years of experience

    2+ year in Regulated Industry, Pharm preferred

    Must have previous experience in cGMP environment

    Proven success in method development and validation

    Familiarity/competency in following areas with in-depth knowledge of at least 3:HPLC, GC, GC/LC-MS, FTIR, UV/Vis, SEM, CE, Chiral Separations, dissolution

    Experienced in regulated development process & regulatory requirements.

    Compensation range

    95, ,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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