What are the responsibilities and job description for the Development Chemist position at Unither Pharmaceuticals?
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 with minor supervision. Provides analytical support of complex, multi-disciplinary projects with minimum input. Implements improvements to lab quality systems. Provides analytical support commercial products and Manufacturing. Provide technical resource for QC laboratories
Essential Duties / Responsibilities
Solutions that Minimize Commercial Lab & Manufacturing Downtime (20 %)
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.
Efficiency Improvements to Existing Methods (20%)
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.
Methods for New Products & Product Transfers (40%)
Provides consultation regarding new test methods as required.
Performs analytical method development, validation, and project support from design to execution.
Performs product development stability to support regulatory submissions.
Provides scientifically sound, clearly written analytical data packages/reports suitable for submission.
Writes and execute analytical method transfer, method verification and method validation protocols and reports.
Able understand and execute compendial methods with minimal supervision.
Reviews and checks analytical data generated by peers and maintains integrity of data.
The ability to familiarize, understand and implement new analytical instrumentation and technologies
Internal Analytical Support (20%)
Provides process method validation protocols and reports for commercial testing.
Your profile
Education & Experience
Associate's degree in science required (Chemistry preferred) and 5-10 years of experience. Bachelor’s degree preferred. 2 years in a regulated industry, pharmaceuticals preferred.
Proven experience in method development and validation
Familiarity/competency in following areas with in-depth knowledge of at least 2:HPLC, GC, GC/LC-MS, FTIR, UV/Vis, SEM, , ,ICP-MS and/or dissolution
Knowledge, Skills & Abilities
Experienced in regulated development process & regulatory requirements
Statistical data evaluation to include experimental design a plus.
Familiarity with LIMS and experience with instrument operating software
Outlook, Word, PowerPoint experience
Intermediate Excel Skills Highly Preferred
PHYSICAL REQUIREMENTS/ENVIRONMENT:
The ability to read, write and communicate in English.
Work responsibilities involve chemical and biological agents that have assigned biological and chemical hazards.
Sitting approximately 50% of day and standing approximately 50% of day.
Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping and fine manipulation.
Occasional lifting of up to 35 pounds.
Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics.
Occasionally subjected to weekend, holiday and irregular hours.
Scope Of Decision-making
Decisions require basic/routine analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.
Level Of Supervision Provided
Project direction of other employees performing the same or directly related work.
Internal / External Contacts
Primarily within department or immediate work unit: Requires contacts within the department or functional area on routine matters, or contacts with other departments. Occasionally contacts individuals outside the organization. Contacts are primarily for the purpose of supplying or seeking information.
Compensation Range
70,000.00 - 78,000.00 USD
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!
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 with minor supervision. Provides analytical support of complex, multi-disciplinary projects with minimum input. Implements improvements to lab quality systems. Provides analytical support commercial products and Manufacturing. Provide technical resource for QC laboratories
Essential Duties / Responsibilities
Solutions that Minimize Commercial Lab & Manufacturing Downtime (20 %)
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.
Efficiency Improvements to Existing Methods (20%)
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.
Methods for New Products & Product Transfers (40%)
Provides consultation regarding new test methods as required.
Performs analytical method development, validation, and project support from design to execution.
Performs product development stability to support regulatory submissions.
Provides scientifically sound, clearly written analytical data packages/reports suitable for submission.
Writes and execute analytical method transfer, method verification and method validation protocols and reports.
Able understand and execute compendial methods with minimal supervision.
Reviews and checks analytical data generated by peers and maintains integrity of data.
The ability to familiarize, understand and implement new analytical instrumentation and technologies
Internal Analytical Support (20%)
Provides process method validation protocols and reports for commercial testing.
Your profile
Education & Experience
Associate's degree in science required (Chemistry preferred) and 5-10 years of experience. Bachelor’s degree preferred. 2 years in a regulated industry, pharmaceuticals preferred.
Proven experience in method development and validation
Familiarity/competency in following areas with in-depth knowledge of at least 2:HPLC, GC, GC/LC-MS, FTIR, UV/Vis, SEM, , ,ICP-MS and/or dissolution
Knowledge, Skills & Abilities
Experienced in regulated development process & regulatory requirements
Statistical data evaluation to include experimental design a plus.
Familiarity with LIMS and experience with instrument operating software
Outlook, Word, PowerPoint experience
Intermediate Excel Skills Highly Preferred
PHYSICAL REQUIREMENTS/ENVIRONMENT:
The ability to read, write and communicate in English.
Work responsibilities involve chemical and biological agents that have assigned biological and chemical hazards.
Sitting approximately 50% of day and standing approximately 50% of day.
Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping and fine manipulation.
Occasional lifting of up to 35 pounds.
Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics.
Occasionally subjected to weekend, holiday and irregular hours.
Scope Of Decision-making
Decisions require basic/routine analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.
Level Of Supervision Provided
Project direction of other employees performing the same or directly related work.
Internal / External Contacts
Primarily within department or immediate work unit: Requires contacts within the department or functional area on routine matters, or contacts with other departments. Occasionally contacts individuals outside the organization. Contacts are primarily for the purpose of supplying or seeking information.
Compensation Range
70,000.00 - 78,000.00 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.
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!
