Address
Form of workJob Title
Staff Analytical Chemist
Requisition
JR000013618 Staff Analytical Chemist (Open)
Location
Raleigh, NC (Pharma) - USA033
Additional Locations
Raleigh, NC
Job Description
Staff Analytical Chemist is responsible for performing analytical support coordination for the Raleigh site, including developing and managing all test methods, assisting project/process development, manage commercial analytical laboratories, and ensuring continued regulatory compliance of lab operations. Performs new instrument, computer system, and method validations. Supports the QC Testing Engineer in coordinating maintenance and performing troubleshooting for laboratory instruments. Maintains contact with Corporate analytical functions to maintain best practices. Recommends analytical methods for non-routine samples needed for troubleshooting and design purposes. Partners with the site for analytical troubleshooting and chemical research and development support.
ESSENTIAL FUNCTIONS:
Provides technical support, non-routine analysis, and quality assessments using good analytical technique and judgement as needed by Raleigh site. Complies with cGMP expectations for a Quality Control laboratory. Participate in site projects as a subject matter expert for testing and analysis. Represents the main contact for QC technical support. Design and manage complex experimental methods and equipment to mimic existing and potential manufacturing processes. Responsible for coordination and review of external analytical laboratory activities, in support of routine, non-routine, and project based work. Responsible for developing and maintaining test methods used in the QC Testing laboratory. Performs periodic reviews and implements improvements for compliance and efficiency. Responsible for authoring, performing, and reviewing method validations with support from the QC Testing Engineers. Develops and executes training for the QC lab. Provides QC Technicians with training on new techniques and instruments, remedial training to correct improper technique, and training in new skill areas to broaden knowledge. Assists with performing or coordinating preventive maintenance, predictive maintenance, and calibrations on laboratory instruments. Continuously improves instrument reliability and backup systems. Support investigations related to Exceptions, OOS, and process upsets. May need to utilize ad-hoc test methods to support site troubleshooting efforts. Participates in customer and regulatory audits as requested. Review and approve changes that impact the QC laboratory. Assist with reviewing changes for impact to process chemistry. Assumes responsibilities of QC Testing Engineers in their absence.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
MINIMUM REQUIREMENTS:
Education required/ preferred:
PhD in a Chemistry discipline or related field with 5 years of related experience. Masters degree in Chemistry with 8 years of related experience or BS in Chemistry with 10 years of related experience are acceptable substitutions.
Experience:
Must have at least 3 years in an industrial laboratory as a chemist. Preferred experience in the pharmaceuticals industry with proven method development.
Preferred Skills/Qualifications:
Experience supporting a manufacturing process or process/method development in the pharmaceuticals industry is preferred.
Advanced knowledge of compendial testing (USP, EP, JP, ANVISA, etc.) and experience with regulatory bodies in an audit setting is preferred.
Required Skills/Competencies:
Must demonstrate advanced problem-solving skills. Must be able to comprehend and independently carry out written procedures, record results and observations, and perform mathematical calculations.
Must have a basic knowledge of chemical properties and reaction mechanisms with experience in testing practices and instruments. Must have a broad understanding of laboratory operations and required resources encompassing a full spectrum of analytical techniques. Good laboratory technique and procedural understanding is essential to facilitate independent work on analytical assignments. Must have good working knowledge of cGMP and Q7A regulations and be familiar with 21 CFR Part 211, and foreign pharmacopeia.
Ability to detect and solve problems with chemical analysis technique or an analytical instrument.
Ability to develop and conduct individual and small group training.
Sound and correct technical judgements required during routine and nonroutine analysis.
Good instrument and mechanical troubleshooting skills.
Strong computer skills.
Strong priority setting.
Excellent written communication and technical writing.
Customer focused and good interpersonal skills with teammates, coworkers, and external vendors.
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
WORKING CONDITIONS:
Works in an analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments. An office with adequate space and lighting is provided to handle computer work, paperwork, and interaction with other Plant personnel.
Normal dexterity is required for routine handling of laboratory glassware and instruments. Must be able to well-visualize and distinguish color. Must be able to visualize slight differences in volumes of liquids in appropriate glassware. Boxes of solvents, compressed gas cylinders, records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area.
Assigned tasks may require visits to the manufacturing area or warehouse. Must be willing and able to wear PPE including hard-hat, steel toed shoes, safety glasses, and other equipment as deemed necessary by EHS, leadership team, corporate, or safety guidelines for the position. Exposure to fugitive emissions of chemicals typical for chemical operations.
Position may require some travel to other Mallinckrodt sites or vendor locations (Less than 5%).
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
NOTE: Please attach an organizational chart to the job description.
Staff Analytical Chemist
Requisition
JR000013618 Staff Analytical Chemist (Open)
Location
Raleigh, NC (Pharma) - USA033
Additional Locations
Raleigh, NC
Job Description
Staff Analytical Chemist is responsible for performing analytical support coordination for the Raleigh site, including developing and managing all test methods, assisting project/process development, manage commercial analytical laboratories, and ensuring continued regulatory compliance of lab operations. Performs new instrument, computer system, and method validations. Supports the QC Testing Engineer in coordinating maintenance and performing troubleshooting for laboratory instruments. Maintains contact with Corporate analytical functions to maintain best practices. Recommends analytical methods for non-routine samples needed for troubleshooting and design purposes. Partners with the site for analytical troubleshooting and chemical research and development support.
ESSENTIAL FUNCTIONS:
Provides technical support, non-routine analysis, and quality assessments using good analytical technique and judgement as needed by Raleigh site. Complies with cGMP expectations for a Quality Control laboratory. Participate in site projects as a subject matter expert for testing and analysis. Represents the main contact for QC technical support. Design and manage complex experimental methods and equipment to mimic existing and potential manufacturing processes. Responsible for coordination and review of external analytical laboratory activities, in support of routine, non-routine, and project based work. Responsible for developing and maintaining test methods used in the QC Testing laboratory. Performs periodic reviews and implements improvements for compliance and efficiency. Responsible for authoring, performing, and reviewing method validations with support from the QC Testing Engineers. Develops and executes training for the QC lab. Provides QC Technicians with training on new techniques and instruments, remedial training to correct improper technique, and training in new skill areas to broaden knowledge. Assists with performing or coordinating preventive maintenance, predictive maintenance, and calibrations on laboratory instruments. Continuously improves instrument reliability and backup systems. Support investigations related to Exceptions, OOS, and process upsets. May need to utilize ad-hoc test methods to support site troubleshooting efforts. Participates in customer and regulatory audits as requested. Review and approve changes that impact the QC laboratory. Assist with reviewing changes for impact to process chemistry. Assumes responsibilities of QC Testing Engineers in their absence.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- Demonstrates the ability to work independently, stay focused, and use time wisely.
- Participates in housekeeping program and keeps workspace organized.
- Assist in reviewing new materials across site for quality impact.
- Demonstrates advanced problem solving skills to analyze and complete failure investigations and analytical testing problems.
- Thoroughly understand each instrument's operational theory in order to recognize technical problems and be able to derive appropriate solutions and repairs. Technologies include liquid chromatography, UV/Vis spectrophotometry, FTIR, NIR, Hunter Color and Karl Fischer Titrator
- Responsible for any non-routine analytical work needed to solve plant problems.
- Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS:
Education required/ preferred:
PhD in a Chemistry discipline or related field with 5 years of related experience. Masters degree in Chemistry with 8 years of related experience or BS in Chemistry with 10 years of related experience are acceptable substitutions.
Experience:
Must have at least 3 years in an industrial laboratory as a chemist. Preferred experience in the pharmaceuticals industry with proven method development.
Preferred Skills/Qualifications:
Experience supporting a manufacturing process or process/method development in the pharmaceuticals industry is preferred.
Advanced knowledge of compendial testing (USP, EP, JP, ANVISA, etc.) and experience with regulatory bodies in an audit setting is preferred.
Required Skills/Competencies:
Must demonstrate advanced problem-solving skills. Must be able to comprehend and independently carry out written procedures, record results and observations, and perform mathematical calculations.
Must have a basic knowledge of chemical properties and reaction mechanisms with experience in testing practices and instruments. Must have a broad understanding of laboratory operations and required resources encompassing a full spectrum of analytical techniques. Good laboratory technique and procedural understanding is essential to facilitate independent work on analytical assignments. Must have good working knowledge of cGMP and Q7A regulations and be familiar with 21 CFR Part 211, and foreign pharmacopeia.
Ability to detect and solve problems with chemical analysis technique or an analytical instrument.
Ability to develop and conduct individual and small group training.
Sound and correct technical judgements required during routine and nonroutine analysis.
Good instrument and mechanical troubleshooting skills.
Strong computer skills.
Strong priority setting.
Excellent written communication and technical writing.
Customer focused and good interpersonal skills with teammates, coworkers, and external vendors.
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
- Reports to Quality Control Manager
- Frequent interaction with operators, engineers, and quality management for routine and nonroutine analytical results. Communication may be verbal or written via email or technical reports.
- Works in a team environment, coordinating with QC Supervisor to assign tasks to Quality Technicians as needed.
- Works closely with QC Testing Engineers to achieve department goals.
- Ability to understand the timely nature of work and fast changing of priorities are necessary to complete assigned tasks.
- Majority of work is performed independently without direct supervision. No supervisory responsibilities are assigned to the Chemist, but they do provide indirect leadership of QC Technicians or may lead projects.
- Inability to work with set priorities can result in process delays and/or missed shipping commitments, so a focus on priorities is a must.
- Customer-requested specifications and Mallinckrodt methods of analysis are considered confidential for marketing purposes.
WORKING CONDITIONS:
Works in an analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments. An office with adequate space and lighting is provided to handle computer work, paperwork, and interaction with other Plant personnel.
Normal dexterity is required for routine handling of laboratory glassware and instruments. Must be able to well-visualize and distinguish color. Must be able to visualize slight differences in volumes of liquids in appropriate glassware. Boxes of solvents, compressed gas cylinders, records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area.
Assigned tasks may require visits to the manufacturing area or warehouse. Must be willing and able to wear PPE including hard-hat, steel toed shoes, safety glasses, and other equipment as deemed necessary by EHS, leadership team, corporate, or safety guidelines for the position. Exposure to fugitive emissions of chemicals typical for chemical operations.
Position may require some travel to other Mallinckrodt sites or vendor locations (Less than 5%).
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
NOTE: Please attach an organizational chart to the job description.
