Principal Analytical Chemist 9/16/2017
JOB DESCRIPTIONAPPLY JOB DESCRIPTION
This individual will perform development activities related to new products and support existing products for both oral and injectable dosage forms. Provide technical leadership on analytical issues. Lead and perform activities to support R&D projects and plants in the area of impurity profiling for API and DP, unknown identification, trace analysis, characterization with the use of advanced analytical techniques. Lead and perform Extractable and Leachable studies for API and DP container closure systems, manufacturing components, and medical devices. Develop, evaluate, validate, and transfer challenging analytical methods. Provide accurate chemical and instrumental test results in support of R&D projects. Ensures quality of data and documentation conforms to established standards.
Must possess advanced knowledge of area of analytical chemistry. May contribute to the development of new concepts, practices and standards. Must demonstrate expertise in different analytical techniques, theory, application, troubleshooting, etc. Must have in-depth knowledge and extensive hands-on experience with method development for HPLC, GC, mass spectrometry, and spectroscopy. Must have extensive experience in LC/MS, GC/MS, and/or ICP/MS techniques. Must have experience in Extractable and Leachable area, and associated guidelines on E&L. Must have experience with method validation and transfers for pharmaceutical methods according to current regulatory guidelines. Evaluates and defines function activities for projects and determines appropriate timeline; coordinates activities with functional resources; keeps functional activities on schedule. Directly or indirectly supervises/mentors others; delegate activities appropriately. Demonstrates excellent verbal and written communication skills. Develops alternatives and solutions for a range of complex problems. Solutions require creativity, critical thinking, and collaboration, considering a broad range of potential impacts, including those that are downstream.
DEPARTMENT SPECIFIC FUNCTIONS:
Represents a function as core team member for R&D projects. Maintain knowledge of current analytical and laboratory practices including a current understanding of USP/EP, cGMP regulations, ICH and FDA Guidance Documents. Familiar with CDFSS/ DFSS (Operational Excellence) tools and applies these tools as appropriate. Familiar with requirements of various pharmacopeias (USP, EP, JP) and basic regulatory requirements and applies knowledge appropriately to activities. Experience in preparing summaries for IND and/or preparing sections of the CMC for ANDAs or NDAs. Experience in Extractables and Leachables area
* PhD in Chemistry or related science with a minimum of 5 years of pharmaceutical or related work experience in field.
* MS in Chemistry or related science typically with a minimum 8 years of pharmaceutical or related work experience in field.
* BA or BS in Chemistry, Biology, Pharmaceutical Science, Physics, or related science typically with a minimum of 10 years of pharmaceutical or related work experience in field.
Good written and verbal communication skills. Demonstrated ability to work well in a fast-paced team setting, especially in a resource limited environment. Demonstrated ability to take concepts and produce laboratory results leading to drug development, preferably for a launched product or one in late stage clinical trials.
A working knowledge of laboratory procedures is necessary along with effective oral and written communication skills. Individual must demonstrate problem solving skills and technical competency. Demonstrate the ability to work effectively in a team environment. Desirable laboratory skills include mass spectroscopy, laboratory automation, and extensive experience with liquid chromatography (to include a variety of detection modalities). A strong emphasis is placed on demonstrated ability for independent problem solving.
The laboratory facility is air conditioned and environmentally controlled. Employees are required to wear eye protection and lab coats while in the lab area. The employee occasionally lifts and/or moves up to 25 lbs., and may be exposed to toxic or caustic chemicals.
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..
Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.