The Analytical Development Chemist is responsible for developing analytical methods and improvement of existing methods, along with performing routine assay using modern instrumentation.
ESSENTIAL JOB FUNCTIONS
- Independently develops analytical methods for new products and new ingredients used in personal care products
- Independently develops analytical methods to support applicable regulatory requirement for current products and ingredients
- Proficient with GC/MS Masshunter software and mass spectral interpretation along with structure elucidation of small organic molecules.
- Method development and identification of trace level small molecules that may result from process impurities, degradation products, or metabolites using but not limited to mass spectrometry.
- Maintain accurate and complete notebook records for all method developmental, validation, and investigational studies in accordance with SOPs and protocols.
- Writes and/or reviews procedures, protocols, summary reports and specification documents needed to support product development efforts.
- Provides wide scope of expertise to business team regarding analytical matters.
- Plans, monitors and performs chemical and physical testing on formulas and packaging components of stability samples.
- Plans, monitors and performs assay validation for new/modified methods and new products.
- Participates on and/or leads cross functional teams within Quality and R & D for special projects.
- Maintains all analytical instruments in proper condition, including the calibration of instruments on a pre-determined time interval.
- Conducts technical literature searches.
- Provides laboratory and instrument training to technicians and coordinates technicians work schedule, where appropriate.
- Coordinates required departmental activities with other groups as needed.
- Leads and performs troubleshooting on analytical matters.
- Leads and is responsible for transferring technical documentation including assay methods, stability data summary reports and product analytical specifications of new products from pilot scale to full-up production.
- Explores and recommends new technologies, instruments and materials, which may have application for the product line.
- Develops and presents to the Manager, Analytical Development and Product Support matters requiring his/her decision.
- Conducts the transition of new products from pilot scale to full-up production, including the development of specifications, procedures, and methodologies.
- Keeps abreast of current trends, practices, developments and regulatory changes, which would impact products, procedures or packaging.
- Ensures the maintenance and/or adherence to good laboratory practices and all safety regulations.
- Creates, contributes and/or reviews Corporate SOPs and Departmental Guideline documents either independently or in conjunction with other departments.
- Maintains the confidentiality of all data and easy accessibility of such records.
- Provides technical knowledge in guiding other chemists in the Quality Laboratory.
- In conjunction with Manager, Analytical Development and Product Support, coordinates contract labs for required outside studies including writing/reviewing protocols, data and reports.
EDUCATION AND EXPERIENCE
- Performs and assumes other duties and responsibilities, as may be required by the Manager, Analytical Development and Product Support and/or Quality Director.
- Supports the Winner’s Circle and ISO processes.
- A B.S. in Chemistry or related discipline; or equivalent in training and experience.
- The knowledge and skills required for this position are typically acquired in 5 to 7 years of experience in a pharmaceutical or related healthcare industry.
SKILLS AND ABILITIES
- Strong background in theory and fundamentals of mass spectrometry and ionization methodologies for small organic molecules.
- Extensive experience in characterization of small organic molecules, natural products, synthetic polymers by mass spectrometry along with a background in theoretical and experimental organic chemistry to propose the origin of unknown components.
- Excellent oral and written communication skills; highly organized and efficient record keeping.
- Ability to provide clear reports and scientific direction to management, colleagues and collaborators.
- Must possess strong analytical skill and complex problem solving skills.
- Experience with chromatographic (HPLC/GC) method development, validation, and transfer.
- Experience with Mass Spectrometry structural characterization.
- Ability to effectively coach and mentor other analytical chemists.
- Good math aptitude.
- Considerable interpersonal skills are required to interact with internal and external customers.
- Strong verbal and written communication skills.
- A broad understanding of physical and chemical properties of chemicals, OSHA regulations, FDA regulations, USP, and cGMP with ability of adhering/complying to very disciplined scientific procedures.
- Willingness to accept other duties, as assigned.
- Must be discreet with confidential information of which he/she has access.
- Demonstrated proficiency in office and laboratory instrument software.
- Must possess the ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management and comply with Company policies
MENTAL AND PHYSICAL DEMANDS
- Physical demands include standing up 75% of the time and a combination of sitting down, writing, analyzing and calculating 25% of the time.
- Travel and overtime requirements are dependent upon departmental demands.
- Good working conditions, however, occasionally exposed to elements such as fumes and odors.
- The daily schedule of a Development Chemist is comprised of working with chemicals 100% of the time.